obtained with the new HD FoV 5. 0 algorithm are compared with its
predecessor, the HD FoV 4. 0 algorithm, based on physical and
anthropomorphic phantoms.
In addition to the bench test, the performance of the algorithm was
evaluated by board-approved radio-oncologists and medical physicists by
means of retrospective blinded rater study.
This comparison is conducted to demonstrate that the HD FoV 5. 0
algorithm is as safe and effective as the HD FoV 4. 0 algorithm.

The performed bench test report describes the technical background of
Flex 4D Spiral and its functionalities with SOMATOM CT scanners,
demonstrate the proper function of those, and assess the image quality
of Flex 4D Spiral.

The bench test evaluates the performance of the ZeeFree RT
reconstruction. The objectives of the tests are to demonstrate that
compared to the Standard reconstruction, ZeeFree RT
• introduces no relevant errors in terms of CT values and noise
levels measured in a homogeneous water phantom, and
• introduces no relevant errors in terms of CT values measured in
a phantom with tissue-equivalent inserts, even in the presence
of metals and in combination with the iMAR algorithm, and
• introduces no relevant geometrical distortions in a static torso
phantom, and
• introduces no relevant deteriorations of the position or shape of
a dynamic thorax phantom when moving a spherical shape
according to regular, irregular, and patient breathing motion.
In addition, the performance of the algorithm was evaluated by board-
approved radio-oncologists by means of a retrospective blinded rater
study on 30 patient cases of respiratory 4D CT examinations.
The test results show that the ZeeFree RT reconstruction
• can successfully be applied to 4D respiratory-gated sequence
images (Direct i4D), and
• enables the optional reconstruction of stack artefact corrected
images, which reduce the strength of misalignment artefacts, if
such stack alignment artefacts are identified in non-corrected
standard images, and
• does not introduce relevant new artefacts, which were
previously not present in the non-corrected standard
reconstruction, and


Feature/Non-clinical
Bench Testing performed

• does not affect CT values and noise levels in a homogenous
water phantom outside of stack-transition areas compared to
the non-corrected standard reconstruction, and
• can be successfully applied in combination with metal artifact
correction (iMAR) and does not introduce new artifacts, which
were previously not present in the non-corrected standard
reconstruction, even in presence of metals, and
• can be successfully applied to phantom data if derived from a
suitable motion phantom demonstrating its correct technical
function on the tested device, and
• is independent from the physical detector width of the acquired
data. By design, input images for the correction part of the
algorithm are independent of kernel, slice thickness and
increment since those parameters are fixed.

The test results show for the iBHC variants Artificial120, eDDensity,
mDDensity and StoppingPowerRatio a reduced dependence on tube
voltage and filtration compared to the corresponding quantitative kernel
(Qr) with iBHC Bone for non-water-like tissues, such as adipose and
bone. Furthermore, the iBHC variants Artificial120, eDDensity,
mDDensity and StoppingPowerRatio generate image value closely
aligned with the respective material properties. In conclusion, the
feature DirectDensity at any kV has been validated for the release Som/X
VB20 on all supported SOMATOM CT scanner models


Digital Imaging and
Communications in
Medicine (DICOM) Set

Supplemental
Requirements for User
Information and System
Function Related to Dose in
CT

Table 7: Recognized Consensus Standards.


Evaluation and routine
testing in medical imaging
departments - Part 3-5:
Acceptance tests and
constancy tests - Imaging
performance of computed
tomography X-ray
equipment [Including:
Technical Corrigendum 1
(2006)]

Evaluation and routine
testing in medical imaging
departments - Part 2-6:
Constancy tests - Imaging
performance of computed
tomography X-ray
equipment

60601-1-3 Edition
2.2 2021-01
CONSOLIDATED
VERSION

Medical electrical
equipment - Part 1-3:
General requirements for
basic safety and essential
performance – Collateral
Standard: Radiation
protection in diagnostic X-
ray equipment

Medical electrical
equipment - Part 2-44:
Particular requirements for
the basic safety and
essential performance of x-
ray equipment for
computed tomography

Medical devices -
Applications of risk
management to medical
devices

Medical devices -
Application of risk
management to medical
devices

Medical device software -
Software life cycle


processes [Including
Amendment 1 (2016)]

62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION

Medical device software -
Software life cycle
processes

Medical electrical
equipment - Part 1:
General requirements for
basic safety and essential
performance (IEC 60601-
1:2005, MOD) [Including
Amendment 2 (2021)]

Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances -
Requirements and tests

60601-1-2 Edition
4.1 2020-09
CONSOLIDATED
VERSION

Medical devices Part 1:
Application of usability
engineering to medical
devices, including
Amendment 1

62366-1 Edition 1.1
2020-06
CONSOLIDATED
VERSION

Medical devices - Part 1:
Application of usability
engineering to medical
devices

Safety of laser products -
Part 1: Equipment
classification, and
requirements


60601-1-6 Edition
3.2 2020-07
CONSOLIDATED
VERSION

Medical electrical
equipment - Part 1-6:
General requirements for
basic safety and essential
performance - Collateral
standard: Usability

Medical electrical
equipment - Part 2-28:
Particular requirements for
the basic safety and
essential performance of X-
ray tube assemblies for
medical diagnosis

62563-1 Edition 1.2
2021-07
CONSOLIDATED
VERSION

Medical electrical
equipment - Medical image
display systems - Part 1:
Evaluation methods


Medical electrical
equipment - part 1:
general requirements for
basic safety and essential
performance

Conformity Assessment –
Supplier’s declaration of
conformity – Part 1:
General requirements

Declaration of
conformance to FDA
recognized consensus
standards.

Conformity assessment –
Supplier’s declaration of
conformity – Part 2:
Supporting
documentation.

General consensus
standards not currently
recognized by FDA.

Table 8: General Use Consensus Standards.


User Fees and Refunds for Premarket Notification Submissions (510(k)s):
Guidance for Industry and Food and Drug Administration Staff

Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug
Administration Staff

Electronic Submission Template for Medical Device 510(k) Submissions

Deciding When to Submit a 510(k) for a Change to an Existing Device

The 510(k) Program: Evaluating Substantial Equivalence in Premarket
Notifications [510(k)]

Content of Premarket Submissions for Software Contained in Medical
Devices

Off-The-Shelf Software Use in Medical Devices

Applying Human Factors and Usability Engineering to Medical Devices

Pediatric Information for X-ray Imaging Device Premarket Notifications

Cybersecurity in Medical Devices: Quality System Considerations and Content
of Premarket Submissions

Electromagnetic Compatibility (EMC) of Medical Devices

Design Considerations and Pre-market Submission Recommendations for
Interoperable Medical Devices

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions
for Medical Devices

Table 9: FDA Guidance Document and Effective Date


Subject Device
Aidoc’s BriefCase-Triage: CARE Multi-Triage
CT for Pneumothorax; Pericardial effusion;
Large aortic aneurysm; Shoulder fracture
or dislocation

Predicate Device
Aidoc’s Briefcase-Triage for AD
(K251406)

BriefCase-Triage: CARE (Clinical AI
Reasoning Engine) Multi-Triage CT for
Pneumothorax; Pericardial effusion; Large
aortic aneurysm; Shoulder fracture or
dislocation device is a radiological computer
aided triage and notification software
indicated for use in the analysis of contrast
and non-contrast CT images of the chest,
abdomen, or chest/abdomen, in adults or
transitional adolescents aged 18 and older.
The device is intended to assist hospital
networks and appropriately trained medical
specialists in workflow triage by flagging
and communicating suspected positive
findings, per study, of:
1. Pneumothorax;
2. Pericardial effusion;
3. Large aortic aneurysm
4. Shoulder Fracture or Dislocation
The device flags cases with at least one
suspected finding to assist with
triage/prioritization of medical images. The
device will provide a flag for each suspected

BriefCase-Triage is a radiological
computer aided triage and notification
software indicated for use in the analysis
of CT chest, abdomen, or chest/abdomen
exams with contrast (CTA and CT with
contrast) in adults or transitional
adolescents aged 18 and older. The
device is intended to assist hospital
networks and appropriately trained
medical specialists in workflow triage by
flagging and communication of suspected
positive findings of Aortic Dissection (AD)
pathology.
BriefCase-Triage uses an artificial
intelligence algorithm to analyze images
and highlight cases with detected findings
on a standalone desktop application in
parallel to the ongoing standard of care
image interpretation. The user is
presented with notifications for cases
with suspected findings. Notifications
include compressed preview images that
are meant for informational purposes


finding within this study. A preview image
will be provided for each distinct suspected
finding.
BriefCase-Triage uses a foundation
model-based artificial intelligence (AI)
system to analyze images and highlight
cases with detected findings in parallel to
the ongoing standard of care image
interpretation. The user is presented with
notifications for cases with suspected
findings. Notifications include compressed
preview images for each suspected finding
that are meant for informational purposes
only and not intended for diagnostic use
beyond notification. The device does not
alter the original medical images and is not
intended to be used as a diagnostic device.
The results of BriefCase-Triage are intended
to be used in conjunction with other patient
information and based on their professional
judgment to assist with triage/prioritization
of medical images. Notified clinicians are
responsible for viewing full images per the
standard of care.

only and not intended for diagnostic use
beyond notification. The device does not
alter the original medical image and is
not intended to be used as a diagnostic
device.
The results of BriefCase-Triage are
intended to be used in conjunction with
other patient information and based on
their professional judgment, to assist
with triage/ prioritization.

Hospital networks and appropriately trained
medical specialists

1. Pneumothorax;
2. Pericardial effusion;
3. Large aortic aneurysm;
4. Shoulder fracture or dislocation


Notificatio
n-only
(/notificati
on alerts),
parallel
workflow
tool

No. No cases are removed from
desktop app or deprioritized

Inclusion/
Exclusion
criteria for
clinical
performa
nce
testing

Inclusion Criteria:
● Patient population: CT scans
performed on adults/transitional
adults ≥ 18 years of age
● Slice thickness: 0.5 mm - 5.0 mm
axial
● Contrast-enhanced and
non-contrast CT images*
Exclusion Criteria
● All studies that have an inadequate
field of view.
*Contrast and non-contrast CT images of
the chest, abdomen, or chest/abdomen as
applicable to indication-specific inclusion
criteria.

Inclusion Criteria
● Scans performed on
adults/transitional adolescents ≥
18 years of age.
● CT exams with contrast (CTA and
CT with contrast) that include at
least part of the aorta
● Slice thickness 0.5 mm - 5.0 mm
Exclusion Criteria
● All studies that have an
inadequate field of view.


Multi-triage module, locked artificial
intelligence algorithm fine tuned from a
foundation model.

Single-triage module, locked, artificial
intelligence algorithm fine tuned from a
foundation model.

- Integrated with image routing module via
image communication platform (ICP) (image
acquisition).
- Algorithm module (image processing)
- Integrated with desktop application for
workflow integration (feed and
non-diagnostic Image Viewer).


AUC
Sensitivity (Se)
Specificity (Sp)
Case Count

Indication 4: Shoulder fracture or dislocation


BriefCase-Triage and
compatible image
communication
platform
Time-to-notification

Table 3. Time-to- notification comparison for Briefcase-Triage devices (Seconds)


Indication 1: Pneumothorax
*5 cases were unknown for gender, 4 positive and 1 negative

Indication 4: Shoulder fracture or dislocation
*8 cases were unknown for gender, all positive

Table 5. Descriptive Statistics for Gender


Table 6. Frequency Distribution of Manufacturer


Table 7. Frequency Distribution of Slice Thickness


Table 8. Sensitivity, Specificity for AOP1-AOP4


Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6

Marketed by
Canon Medical Systems USA, Inc.

Interventional Fluoroscopic X-ray System

Image-Intensified Fluoroscopic X-ray System


Number
INFX-8000V/S, V9.6 with
V9.6 with αEvolve Imaging (FOV

12-inch, 10inch (binning)
8-inch, 6-inch (non-binning)
3-inch (hi-def, non-binning)

technological characteristics between the subject and the predicate device is included below.


DHT8B: Division of Radiological Imaging Devices and

Office of Product Evaluation and Quality


Regulation Number
Regulation Name
Product Code

Medical Image Management and Processing System

Regulation Number, Name and Product Code:


Caption Interpretation Automated Ejection Fraction
Software

Automated Radiological Image Processing Software


Clarius Ultrasound Transducers
PA HD3; PAL HD3; C3 HD3

Clarius Ultrasound App (Clarius App) for iOS;
Clarius Ultrasound App (Clarius App) for Android

cleared in K213436 and K232704). Clarius Ejection Fraction AI is not a stand-alone software device.


RATIONALE
(if subject device differs from
predicate device)

Device Trade Name
Clarius Ejection Fraction AI
Caption Interpretation

510(k) Holder/ Manufacturer
Clarius Mobile Health Corp.
Caption Health, Inc.
Not applicable

Submission Reference
Current Submission
K210747
Not applicable

Primary Product Code
QIH
QIH
Same as predicate device.

Automated Radiological
Image Processing Software

Medical Image Management and
Processing System

Regulation Number
21 CFR § 892.2050
21 CFR § 892.2050
Same as predicate device.

Intended for use as an assistive
tool utilizing an artificial
intelligence/machine learning-
based algorithm for semi-
automated measurement of
cardiac ultrasound images for
determination of left ventricular
ejection fraction.

Clarius Ejection Fraction AI is
intended for semi-automatic
non-invasive measurement of
the left ventricular ejection
fraction on ultrasound data
acquired by the Clarius
Ultrasound Scanner (i.e.,
phased array and curvilinear
scanners). The user shall be a
healthcare professional
trained and qualified in
ultrasound. The user retains
the responsibility of
confirming the validity of the

The Caption Interpretation
Automated Ejection Fraction
software is used to process
previously acquired
transthoracic cardiac ultrasound
images, to store images, and to
manipulate and make
measurements on
images using an ultrasound
device, personal computer, or a
compatible DICOM-compliant
PACS system in
order to provide automated
estimation of left ventricular

Equivalent to the predicate
device. Both the subject device
and the predicate device are
indicated for automated/semi-
automated measurement of the
left ventricular ejection fraction
on ultrasound data acquired using
ultrasound devices. Both devices
are intended for use as assistive
“tools” to aid the clinician in
performing cardiac assessments.
The minor differences in the
indications for use between the
subject device and the predicate

Table 1 - Comparison of the Subject Device to the Legally Marketed Device


measurements based on
standard practices and clinical
judgment. Clarius Ejection
Fraction Al is intended for use
in adult patients only.

ejection fraction. This
measurement can be used to
assist the clinician in a cardiac
evaluation.
The Caption Interpretation
Automated Ejection Fraction
Software is indicated for use in
adult patients.

device do not impact the safety
and effectiveness of the subject
device relative to the predicate
device.

Radiological application/
Ultrasound
Ultrasound
Same as predicate device.

Ultrasound image processing
software implementing artificial
intelligence utilizing non-adaptive
machine learning algorithms
trained with clinical and/or
artificial data intended for
measurements of cardiac
ultrasound data.

Quantitative and/or Qualitative
LV EF measurement
LV EF measurement
Same as predicate device.

Yes – Segmentation of anatomical
structures (cardiac anatomy/
heart)

Yes – Measurement of LV ejection
fraction

Artificial Intelligence (AI)/Machine
Learning (ML)

Automation
Yes
Yes
Same as predicate device.

Manual adjustment/Manual
Yes
Yes
Same as predicate device.


RATIONALE
(if subject device differs from
predicate device)

Device Trade Name
Clarius Ejection Fraction AI
Caption Interpretation

Professional healthcare setting
(e.g., hospital, clinic)

Anatomical Site
Heart
Heart
Same as predicate device.

Intended Users
Licensed healthcare professionals
Licensed healthcare professionals
Same as predicate device.

Patient Population
Adults
Adults
Same as reference device.


IEC 62304:2006 + A1:2015 - Medical device software — Software life cycle processes

ISO 14971:2019 Medical devices — Application of risk management to medical devices

IEC 62366-1:2015 + A1:2020 Medical devices — Part 1: Application of usability engineering to
medical devices

ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied

following FDA-recognized consensus standards:


Table 3: ICC values of Reviewers and Clarius Ejection Fraction AI

Reviewer1 vs. Reviewer2
0.67
[0.59 0.74]

Reviewer1 vs. Reviewer3
0.64
[0.53 0.71]

Reviewer2 vs. Reviewer3
0.54
[0.41 0.64]

AI_EF vs. Mean_Reviewers
0.78
[0.71 0.83]

EF AI for the various views/measurement methods, as shown in Table 3 below:


Modification
Rationale
Testing Methods
Impact Assessment

Modification of data
input sources (Clarius
ultrasound scanners)

To add data from
current Clarius
scanners and future
510(k) cleared Clarius
scanners to the Clarius
Ejection Fraction AI
model so the model
can be deployed on
more scanners.

Internal testing, clinical
design validation and
usability validation to
assess the model’s
performance and ensure
it performs as intended
to meet users’ needs.

By accommodating a
wider array of image
geometries and
characteristics with
the use of new
510(k)-cleared
Clarius ultrasound
scanners, the
updated Ejection
Fraction AI model
will be better
equipped to handle
different transducer
models of the
Clarius Ultrasound
Scanner used in
varying clinical
scenarios.
Benefit-Risk
Analysis:
Benefits: Enhanced
compatibility;
Flexibility for diverse
clinical settings.
Risks: Data skewing
and concept drift.

Summary of planned modifications to Clarius Ejection Fraction AI per the PCCP:


Risk Mitigation:
Internal testing to
ensure that data
skewing and
concept drift are
mitigated.

Modification of training
hyperparameters (initial
learning rate, width
multiplier, dropout rate)

Re-training of the
Ejection Fraction AI
model with modified
hyperparameters to
optimize its performance
followed by internal
testing and a comparison
of the original Ejection
Fraction AI model to the
modified Ejection
Fraction AI model (using
performance metrics)
followed with clinical
performance testing
(verification and
validation).

Improved
performance
metrics of modified
Ejection Fraction AI
model with
increased accuracy
and more robust
measurements
displayed to users.
Benefit-Risk
Analysis:
Benefits: Improved
performance;
generalization.
Risks: Overfitting;
unintended bias.
Risk Mitigation:
Proper
regularization
techniques and
cross-validation and
dropout will be
employed to
mitigate overfitting.
Internal testing and
verification will be
conducted to
mitigate unintended
biases.

Improvement and
optimization of Clarius
Ejection Fraction AI’s
performance and
robustness

Internal testing and a
comparison of the
original Ejection Fraction
AI model to the modified
Ejection Fraction AI
model (using
performance metrics)
and clinical performance

Improved
performance
metrics of modified
Ejection Fraction AI
model.
Benefit-Risk
Analysis:


Benefits: Improved
performance;
generalization.
Risks: Overfitting;
unintended bias.
Risk Mitigation:
Proper
regularization
techniques and
cross-validation and
dropout will be
employed to
mitigate overfitting.
Internal testing and
verification will be
conducted to
mitigate unintended
biases.

Modification of masked
autoencoder
architecture and training

Optimization of model
robustness, accuracy,
and generalizability
across diverse patient
populations and
scanning conditions

Internal testing and a
comparison of the
original Ejection Fraction
AI model to the modified
Ejection Fraction AI
model (using
performance metrics)
and clinical performance
testing (verification and
validation).

Improved
performance
metrics of modified
Ejection Fraction AI
model with
increased accuracy,
improved
generalizability, and
more robust
measurements
displayed to users.
Benefit-Risk
Analysis:
Benefits: Improved
performance;
generalization.
Risks: Overfitting;
unintended bias.
Risk Mitigation:
Proper
regularization
techniques and
cross-validation and
dropout will be


Modification
Rationale
Testing Methods
Impact Assessment

employed to
mitigate overfitting.
Internal testing and
verification will be
conducted to
mitigate unintended
biases.


This summary of safety and
effectiveness of information is su

Manufacturer Name and
Philips Ultrasound LLC

Contact Person (Primary):
Lakshmi Sanjana Gondesi

Contact Person
Senior Regulatory Manager

Proprietary Name
EPIQ Series Diagnostic Ultrasou

Common Name
Diagnostic Ultrasound System an


Classification Description
21 CFR §
Product Code

System, imaging, pulsed doppler,
ultrasonic

System, imaging, pulsed echo,
ultrasonic

Transducer, ultrasonic, diagnostic
892.1570
ITX

Automated Radiological Image
Processing Software

Diagnostic Intravascular Catheter
870.1200
OBJ*


Measurement
Mean ± SD (Min, Max)
Mean ± SD (Min, Max)

Table 1. Clinical measurement summary for AI Auto Measure Abdomen and Ground Truth


between AI Auto Measure Abdomen and Ground Truth


Addition of a
new function in
EchoNavigator
R5.0: M-TEER
device
detection (also
known as device
tracking) and
overlay
DeviceGuide
functionality

Mitral Transcatheter Edge-to-Edge Repair
(M−TEER) device detection and overlay involves
detecting the location of the M-TEER therapy
device in the X-ray and echo images (enabled by
Artificial Intelligence).
The TEER device detection and overlay function
has the following optional features:
• visualization of the shape, trajectory, and
orientation of mitral TEER device overlaid on
X-ray and/or echo images.
• device focused echo views (on the TEER
device) to optimize the visualization of the
relationship between device and surrounding
anatomy.
The software element of this functionality

Table 1: Overview of the changes for EchoNavigator R5.0


contains the algorithms to detect/track the
location and orientation of M-TEER therapy
devices (this release only supports Edwards’
PASCAL Ace M-TEER therapy device).
• Input: 2D X-ray image + geometry information
+ 3D echo volume + TEE probe registration
result.
• Output: 3D position, orientation and
openness angle of therapy device, including
detection status.
The intent of this function is to assist physicians in
device guidance and navigation when performing
TEER procedures. This is an -on demand function
for the physician.
Please note that all the other features and the
underlying algorithms of EchoNavigator R5.0 are
the same as the features and underlying
algorithms of the predicate device.
(EchoNavigator R4.0, K221270)

Harmonization of the EchoNavigator UI with the
UI offered on the EPIQ system (Ultrasound
console):
• Harmonize the presentation of echo views
offered in EchoNavigator with those offered
on the EPIQ system, such that there are
minimal differences between the echo views
when the user switches between EPIQ system
and EchoNavigator views.
• Harmonize buttons and button presentation,
bringing it in line with the EPIQ system.

The proposed product claims for EchoNavigator
R5.0 (which are new in comparison to the
predicate device, (EchoNavigator R4.0, K221270))
are as follows:
• Automated visualization of trajectory and
orientation of mitral TEER device
• Improved imaging workflow through a
dedicated user interface for Mitral TEER.
• Automatic device augmentation on echo
(Augmented Reality)
• DeviceGuide offers real-time automatic
device detection, tracking and 3D pose-
estimation in live Echo and live X-ray enabled
by Artificial Intelligence which is built with
Deep Learning technology.


Classification Name:
Magnetic Resonance Diagnostic Device

Regulation Number:
90-LNH (Per 21 CFR § 892.1000)

Vantage Fortian / Orian 1.5T, MRT-1550, V10.0 with AiCE
Reconstruction Processing Unit for MR


Vantage Fortian/Orian 1.5T, MRT-1550,
V10.0 with AiCE Reconstruction Processing
Unit for MR

Marketed By
Canon Medical Systems USA, Inc.


System
Reference Device 1
Reference Device 2

Vantage Orian 1.5T, MRT-1550, V9.0 with
AiCE Reconstruction Processing Unit for
MR

Vantage Orian 1.5T, MRT-1550, V6.0 with
AiCE Reconstruction Processing Unit for
MR

Marketed By
Canon Medical Systems USA, Inc.
Canon Medical Systems USA, Inc.

Clearance Date
April 12, 2024
July 23, 2019


Item
Subject Device:
Predicate Device:
Notes

Vantage Fortian/Orian 1.5T,
Vantage Fortian/Orian 1.5T,

with AiCE Reconstruction
with AiCE Reconstruction

Processing Unit for MR
Processing Unit for MR

Operational Modes
Normal and 1st Operating Mode
Normal and 1st Operating Mode
Same

Allows screen access to 1st level
operating mode

4W/kg for whole body (1st
operating mode specified in IEC
60601-2-33:
2010+A1:2013+A2:2015)


1st operating mode specified in IEC
60601-2-33:
2010+A1:2013+A2:2015

Potential emergency
condition and means
provided for shutdown

Shutdown by Emergency Ramp
Down Unit for collision hazard for
ferromagnetic objects


Recognition
Standard Number and Date
Standard Name

Medical electrical equipment - Part 2-33:
Particular requirements for the basic safety and
essential performance of magnetic resonance
equipment for medical diagnosis

Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD)
[Including Amendment 2 (2021)]Medical
electrical equipment - Part 1: General
requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD)

ANSI AAMI IEC 60601-1-
2:2014 [Including AMD
1:2021]

Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral Standard:
Electromagnetic disturbances - Requirements
and tests [Including Amendment 1 (2021)]


IEC 60601-1-6 Edition 3.2
2020-07 CONSOLIDATED
VERSION

Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability

Medical Electrical Equipment - Part 1-8:
General requirements for basic safety and
essential performance - Collateral Standard:
General requirements tests and guidance for
alarm systems in medical electrical equipment
and medical electrical systems [Including
Amendment 2 (2021)]

Medical device software - Software life cycle
processes [Including Amendment 1 (2016)]

ANSI AAMI IEC 62366-
1:2015+AMD1:2020
(Consolidated Text)

Medical devices Part 1: Application of usability
engineering to medical devices including
Amendment 1

Medical devices – Application of risk
management to medical devices.


Philips Medical Systems Nederland B.V.
Veenpluis 6,
5684 PC Best,
Netherlands

Siwar Assi
Regulatory Affairs Team Lead
Phone: +972-50-7494961
E-Mail: Siwar.Assi@philips.com

Carmit Shmuel
Regulatory Affairs Manager and Site Lead
Phone: +972-54-2109054
E-Mail: Carmit.Shmuel@philips.com

Common name:
System, X-ray, Tomography, Computed

Classification Name
Computed tomography x-ray system

Classification Regulation:
21 CFR 892.1750

Manufacturer:
Philips Medical Systems Nederland B.V.

Classification Name:
Computed tomography x-ray system


AI-based image denoising and image-quality enhancement
functionality integrated within the image reconstruction pipeline.
SPI is derived from the previously cleared Precise Image framework
and does not alter the fundamental image-formation process or
introduce new clinical decision-making functionality.

Spectral Result Generation
Pipeline Optimization

Implemented this pipeline optimization to improve the Spectral
Image Time-to-First-Image (TTFI).

Revision from Version 5.2 to Version 5.4 to accommodate for
changes made under this version control.

The proposed Spectral CT Verida Family system introduces Noah
RT-2 Couch to replace the Noah HP Couch from the cleared to
market primary predicate device, Spectral CT 7500 RT device
(K240844).

The Bayonet Head Holder provides additional scannable range
when plugged into the couch head slot of the proposed Spectral CT
Verida Family system.

Change from HP G4 to HP G5 due to EOL and performance
improvements

Change to support both Varian and Elekta indexing

Table 1: New/Modified features in the proposed device


Proposed Device
Spectral CT Verida Family

Primary Predicate Device
Spectral CT 7500 RT (K240844)

Computer
and CIRS
(Common
Image
Reconstructio
n System)

PC computer based on Intel
processors and custom
Multiprocessor Array

Surview
Axial-after-axial
Dynamic Scan
Helical Scan

0.18 sec for 240° rotation,
0.27 sec for 360° rotation

Table 2 Technological Characteristics Comparison


Scanner Center of Rotation
(COR) is up to 80 mm

16 lp/cm max (high mode)
13 lp/cm max (standard
mode)

Low-contrast
resolution (with
iDose4): 2 mm @
0.3%; ≤ 42mGy
CTDIvol (body), 3 mm
@ 0.3%; ≤ 22 mGy
CTDIvol (body), 4 mm
@ 0.3%; ≤ 15.5 mGy
CTDIvol (body), 5 mm
@ 0.3%; ≤ 14 mGy
CTDIvol (body)
Low-contrast
resolution (with


Precise Image): 5 mm
@ 0.3%; ≤ 5.5 mGy
CTDIvol (body)

Noise in
Standard
Mode (as
measured on
21.6 cm water-
equivalent)

≤0.18% at 120kV,
230mAs,
CTDIcenter(head) ≤
33mGy,
10mm image
thickness,
iDose4

8 cm - Dual-Layer scintillator,
up to 128 detector rows

Single layer ceramic
scintillator plus a
photodiode

Solid-state yttrium-based
scintillator, GOS + Photodiode

Same as primary
predicate
The brand name
of the detector
is updated in
Spectral CT


Proposed Device
Spectral CT Verida Family

Primary Predicate Device
Spectral CT 7500 RT (K240844)

Verida Family to
NanoPanel
Prism Precise 3rd
Gen. No
difference in
characteristics
between
products, no
impact to safety
or effectiveness
of the device.

Various slice thickness options
available in the range of 0.67 -
10 mm for helical mode and


helical mode and 0.625 –
10 for axial mode

0.27 sec -1.5 sec (360°
rotation)
0.18 sec, 0.2 sec (240°
rotation)


Reconstruction speed
(standard console)
Essentials: Up to 80 IPS
Essentials 64: Up to 60
IPS
Reconstruction speed
(enhanced console)
Up to 100 IPS

Substantially
equivalent;
Reconstruction
performance
improvements
for conventional
CT is a part of
this change on
the proposed


Spectral CT
Verida Family.
The verification
and validation
for this
improvement
were conducted
and ensured no
new questions
on safety and/or
effectiveness
will arise.

Substantially
equivalent;
The proposed
Spectral CT
Verida Family
introduces Noah
RT-2 Couch to
replace Noah HP
Couch in cleared


to market
primary
predicate device
Spectral CT 7500
RT system
(K240844).
The verification
and validation
for this
improvement
were conducted
and ensured no
new questions
on safety and/or
effectiveness
will arise.

Maximum Speed = 600 mm/sec
Minimum Speed = 1 mm/sec

Maximum Speed = 300
mm/sec
Minimum Speed = 1
mm/sec


530 mm – STD Couch
430 mm – Noah HP
Couch

0-2413 mm for patient pallet
0-425 mm for sub pallet

With STD couch,
1,830mm—helical
scan
1,860mm—Axial scan
With Noah couch,
1,900mm—helical
scan
2,000mm—Axial scan

Substantially
equivalent;
The proposed
Spectral CT
Verida Family
system
introduces Noah
RT-2 Couch to
replace the
Noah HP Couch.
Compared with
Noah HP Couch,
there’s a sub
pallet in Noah
RT-2 Couch
which provides
the additional
support to the
patient pallet
and can be
motorized


Proposed Device
Spectral CT Verida Family

Primary Predicate Device
Spectral CT 7500 RT (K240844)

moving.
The verification
and validation
for this
improvement
were conducted
and ensured no
new questions
on safety and/or
effectiveness
will arise.

w/o Bayonet Head Holder:
1940mm
w/ Bayonet Head Holder:
2190mm

Substantially
equivalent;
Additional
scannable range
is due to
Bayonet Head
holder plug in
Couch head slot
of the proposed
Spectral CT
Verida Family
system.
The verification
and validation


for this
improvement
were conducted
and ensured no
new questions
on safety and/or
effectiveness
will arise.

w/o Bayonet Head Holder:
2000mm
w/ Bayonet Head Holder: 2250
mm

Substantially
equivalent;
Additional
scannable range
is due to
Bayonet Head
holder plug in
Couch head slot
of the proposed
Spectral CT
Verida Family.
The verification
and validation
for this
improvement
were conducted
and ensured no


new questions
on safety and/or
effectiveness
will arise.

w/o Bayonet Head Holder:
1900mm
w/ Bayonet Head Holder:
2150mm

Substantially
equivalent;
Additional
scannable range
is due to
Bayonet Head
holder plug in
Couch head slot
of the proposed
Spectral CT
Verida Family
system.
The verification
and validation
for this
improvement
were conducted
and ensured no
new questions
on safety and/or
effectiveness


675 lbs. (307 kg)
Utilizing Oncology flat tabletop
optional accessory: 628 lbs.
(285 kg)

Infant Cradle, Paper roller,
Varian Camera Adaptor,
Oncology flat tabletop, Bayonet
Head holder

Infant Cradle, Paper
roller, Oncology flat
tabletop

Substantially
equivalent;
The introduction
of the Bayonet
Head-holder on
the Spectral CT
Verida Family
system is to
allow for
additional
scannable
range.
The verification
and validation
for this


Proposed Device
Spectral CT Verida Family

Primary Predicate Device
Spectral CT 7500 RT (K240844)

improvement
were conducted
and ensured no
new questions
on safety and/or
effectiveness
will arise.

One 1TB SSD for the OS and
Console Software plus one
7.68TB U.2 PCle SSD for results

256GB OS disk plus one 7.68TB
PCIE
NVMe SSD

One 2TB SSD for the
OS and Console
Software.

Substantially
equivalent;
The proposed
Spectral CT
Verida Family
system
introduces an
improvement to
Host Drives
(increased
capacity of
computer
drives).
The verification
and validation
for this


CIRS Rack that contains two HP
Z8 servers.
Option for two additional HP Z8
Servers in the same rack.

CIRS run in the same
PC with Host
in HP Z8

In each HP Z8: Single Intel Xeon
W9-3475X with 36 cores at
2.2GHz .

In each HP Z8: Dual Intel Gold
6230 with 20 cores at 2.1GHz
each.

CPU1: Intel Xeon Silver
4214 processor 2.2
12C
CPU2: Intel Xeon Silver
4214 processor 2.2
12C

Substantially
equivalent;
The proposed
Spectral CT
Verida Family
system
introduces an
improvement to
CIRS CPUs


(increased cores
and higher
frequency).
The verification
and validation
for this
improvement
were conducted
and ensured no
new questions
on safety and/or
effectiveness
will arise.

In each HP Z8:
1TGB NVMe SSD for OS and
CIRS software.
Two 2TB NVMe SSDs for raw
data in CIRS S1

In each HP Z8:
512GB NVMe SSD for OS and
CIRS software.
Two 2TB NVMe SSDs for raw
data in CIRS S1.

Substantially
equivalent;
The proposed
Spectral CT
Verida Family
system
introduces an
improvement to
CIRS drives
(increased size
for OS and CIRS


Proposed Device
Spectral CT Verida Family

Primary Predicate Device
Spectral CT 7500 RT (K240844)

software).
The verification
and validation
for this
improvement
were conducted
and ensured no
new questions
on safety and/or
effectiveness
will arise.

Technical Basis
for collection
of two CT
Spectra:

• Low-energy
• High-energy
• Photoelectric
• Compton Scatter


• Monoenergetic
• Materials Basis/Density
Pairs, such as
I / H20
o
I / Ca
o
Ca / Uric Acid
o
• Effective Atomic
Number
• Material Separation/
Differentiation
• Attenuation Curves
• Density
Measurements/Visualiza
tion
• Reduction of Beam
Hardening
• Reduction of Calcium
Blooming
• Calcium Suppression
Index
• Electron Density

• Monoenergetic
• Materials Basis/Density
Pairs, such as
I / H20
o
I / Ca
o
Ca / Uric Acid
o
• Effective Atomic Number
• Material Separation/
Differentiation
• Attenuation Curves
• Density
Measurements/Visualizat
ion
• Reduction of Beam
Hardening
• Reduction of Calcium
Blooming
• Calcium Suppression
Index
• Electron Density
• Spectral results for
Cardiac

• Monoenergetic
• Materials
Basis/Density Pairs,
such as
I / H20
o
I / Ca
o
Ca / Uric
o
Acid
• Effective Atomic
Number
• Material Separation/
Differentiation
• Attenuation Curves
• Density
Measurements/Visu
alization
• Reduction of Beam
Hardening
• Reduction of
Calcium Blooming
• Calcium Suppression
Index


• Electron Density
• Spectral results for
Cardiac

• Axial (increment of zero)
• Axial Gated (increment
of zero)
• Axial Jog (two table
positions)
• Helical

• Axial
(increment of
zero)
• Axial Jog (two
table positions)


Standard ECG Gated
Reconstruction method
Precise Cardiac (optional
feature)

Standard ECG Gated
Reconstruction method
Motion Compensated
Reconstruction (MCR)


Test Injection
Bolus Timing
(also known as
Time Lapse)


Proposed Device
Spectral CT Verida Family

Primary Predicate Device
Spectral CT 7500 RT (K240844)

Substantially
equivalent;
This algorithm is
built off the CT
5300 (K232491)
clearance that
contains the
Precise Image
reconstruction
algorithm.
Please refer to
the Device
Description and
Software
sections, within
this eSTAR
submission, for
more
information.


Patient Population
Patients of all ages
Same

Head, Body (including bone and lung), Cardiac

DLIR is a recon option implemented on the
operator console for Revolution Apex systems.

Built into routine clinical workflow with 3
strengths to select from (Low, Medium, High)

510(k) Premarket Notification Submission - True Definition DL


Demographics
Number of patients (percentage)

North America: 58 (72.5%)
Europe: 3 (3.75%)
Asia: 19 (23.75%)
None of these testing data were from the same
clinical sites which provided the training data.


performance statistics and acceptance criteria are:


Subject Device
Philips Medical
Systems' AV
Vascular

Predicate Device
Pie Medical
Imaging’s
3mensio
Structural Heart /
3mensio
Vascular
(K153736)

Reference
Device
Philips Medical
Systems'
Spectral CT
Applications
(K150665)

Comparison
between the
subject and
predicate
devices
(identical/
different)

Device Class
Class II
Class II
Class II
Class II
Identical

Computed
tomography x-ray
system
Medical image
management and
processing
system

AV Vascular is
indicated to assist
users in the
visualization,
assessment and
quantification of
vascular anatomy

3mensio
Workstation is a
standalone
software for
medical image
analysis intended
for advanced

The Multimodality
Advanced Vessel
Analysis (MM AVA)
application is
intended for
visualization,
assessment and

The Philips
Spectral CT
Applications
support viewing
and analysis of
images at
energies selected


on CTA and/or
MRA datasets, in
order to assess
patients with
suspected or
diagnosed
vascular
pathology and to
assist with pre-
procedural
planning for
endovascular
interventions.

visualization and
quantitative
analysis for
diagnostic and/or
for assistance
during treatment in
the field of
cardiology or
radiology by
means of enabling
visualization and
measurement of
structures of the
heart and vessels
for:
• Pre-operational
planning and
sizing for
cardiovascular
interventions
and surgery
• Postoperative
evaluation
• Support of
clinical diagnosis
by quantifying
dimensions in
coronary arteries
• Support of
clinical diagnosis
by quantifying
calcifications
(calcium scoring)
in the coronary
arteries
To facilitate the
above, the
3mensio
Workstation
provides general
functionality such
as:

from the available
spectrum in order
to provide
information about
the chemical
composition of the
body materials
and/or contrast
agents. The
Spectral CT
Applications
provide for the
quantification and
graphical display
of attenuation,
material density,
and effective
atomic number.
This information
may be used by a
trained healthcare
professional as a
diagnostic tool for
the visualization
and analysis of
anatomical and
pathological
structures.
The Spectral
enhanced
Advanced Vessel
Analysis (sAVA)
application is
intended to assist
clinicians in
viewing and
evaluating CT
images, for the
inspection of
contrast-
enhanced
vessels.


• Segmentation of
cardiovascular
structures
• Automatic and
manual
centerline
detection
• Visualization and
image
reconstruction
techniques: 2D
review, Volume
Rendering,
MPR, Curved
MPR, Stretched
CMRP,
Slabbing, MIP,
AIP, MinIP
• Measurement
and annotation
tools
Reporting tools

The Spectral
enhanced
Comprehensive
Cardiac Analysis
(sCCA)
application is
intended to assist
clinicians in
viewing and
evaluating
cardiovascular CT
images.
The Spectral
enhanced Tumor
Tracking (sTT)
application is
intended to assist
clinicians in
viewing and
evaluating CT
images, for the
inspection of
tumors.

Automatic vessel
centerline
extraction of the
head, neck and


Subject Device
Philips Medical
Systems' AV
Vascular

Predicate Device
Pie Medical
Imaging’s
3mensio
Structural Heart /
3mensio
Vascular
(K153736)

Reference
Device
Philips Medical
Systems'
Spectral CT
Applications
(K150665)

Comparison
between the
subject and
predicate
devices
(identical/
different)

Automatic non-AI
based vessel
contouring of
major vessels.
Automatic AI-
based vessel
contouring
specifically for the
aorta and
common and
external iliac
arteries.

Automatic non-AI
based vessel
contouring of major
vessels, including
the aorta and
common and
external iliac
arteries.

Review Marker
tool including
manual ring
markers, and non-
AI based
automatic ring
markers for the
ostia of the SMA,
LRA and RRA


Predicate Device: SwiftMR – K230854 by AIRS Medical, Inc., Class II, CFR

892.2050, classification with product code LLZ.


SwiftMR is a stand-alone
medical imaging software
solution intended for the
acceptance,
enhancement, processing,
review, analysis,
communication, and
transfer of all body parts
MR images in DICOM
format. The software may
be used for the
enhancement of medical
images, such as noise
reduction and increased
image sharpness for MR
images.
The device is designed for
use by healthcare
professionals and is
intended to assist

SwiftMR is a stand-
alone software solution
intended to be used for
acceptance,
enhancement and
transfer of all body parts
MR images in DICOM
format. It can be used
for noise reduction and
increasing image
sharpness for MR
images. SwiftMR is not
intended for use on
mobile devices.

Equivalent
The subject device is
substantially
equivalent to the
primary predicate,
SwiftMR (K230854),
as they share the
same intended use
and core technological
principles for MR
image processing.


clinicians, who remain
responsible for making all
final patient management
decisions. The device is
not intended for use on
mobile devices.
The available filed
strengths are as follows:
0.25T, 0.31T, 0.4T, 0.55T,
0.6T, 1.5T, and 3.0T.

Equivalent (MR input
consistent with both
predicates)

Healthcare professionals;
final clinical responsibility
remains with clinician

Equivalent to
Predicate device #1
(K230854)


Indications for Use
Please type in the marketing application/submission number, if it is known. This
K253779 ?
textbox will be left blank for original applications/submissions.
Please provide the device trade name(s). ?

Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions.

Please provide your Indications for Use below.

The SIGNA™ Sprint Select is a whole body magnetic resonance scanner designed to support high
resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging
device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and
or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited
to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and
musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents
may be used.
The images produced by SIGNATM Sprint Select reflect the spatial distribution or molecular environment of
nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician
yield information that mav assist in diaQnosis.
Please select the types of uses (select one or both, as [gJ Prescription Use (21 CFR 801 Subpart D)
D ?
applicable). Over-The-Counter Use (21 CFR 801 Subpart C)


GE Medical Systems, LLC
3200 N. Grandview Blvd.
Waukesha, WI USA 53188

Xinyu Song
Lead Specialist, Regulatory Affairs, MR
GE HealthCare
Phone: 86 186 1188 4503
E-mail: Xinyu.Song@gehealthcare.com

Glen Sabin
Director - Regulatory Affairs, MR Strategy
GE HealthCare
Phone: 262 894-4968
E-mail: Glen.Sabin@gehealthcare.com

Magnetic Resonance Diagnostic Device per 21 CFR 892.1000

(1) SIGNATM Champion (K233728)
(2) SIGNATM Victor (K223439)

In accordance with 21 CFR 807.92 the following summary of information is provided:


1.5T Superconducting
Magnet with active
shielding.
The proposed device
offers two
superconducting
magnet options: the
IPM magnet and the
Demeter magnet.

The IPM magnet is identical to the
predicate device’s magnet.
The Demeter magnet is equivalent to
the predicate device’s magnet, and
both the Demeter and IPM magnets
have the same electromagnetic
performance.

predicate/reference devices, as summarized below:


A gradient coil with water-cooled, active-shielded
design.

The gradient subsystem of the
proposed device is equivalent to that
of the predicate device SIGNA™ Sprint
and is identical to the gradient
subsystem of the reference device
SIGNA™ Champion.

1.5T Transmit with embedded body coil and local
T/R coil.

The RF transmit subsystem, excluding
the body coil, is identical to the
predicate device, SIGNA™ Sprint.
The body coil is identical to that of the
reference device, SIGNA™ Champion.

1.5T Direct Digital Interface (DDI) receive chain
architecture.

The RF receive subsystem is
substantially equivalent to the
predicate device, SIGNA™ Sprint, with
an updated FPGA.

Comprehensive suite of 1.5T detachable coils for
imaging all anatomies.

The detachable RF coils are identical to
those of the predicate device, SIGNA™
Sprint, with additional compatible coil
options.

1.5T TDI Posterior
Array or
1.5T AIR Posterior
Array

The 1.5T AIR Posterior Array coil is
identical to the predicate device,
SIGNA™ Sprint’s PA coil.
The 1.5T TDI Posterior Array coil was
previously cleared under K161567.

Comprehensive suite of software features, pulse
sequences, and image processing applications to
support MR imaging of all anatomies.

SIGNA™ Sprint Select uses equivalent
software with predicate and reference
devices.
The base software platform of the
proposed device has been modified
from that of the predicate device to
provide an updated user interface for
the MR system.
The proposed device software platform
featuring various productivity
enhancements that are designed to
maximize workflow and reduce scan
time.


Respiratory peripheral and cardiac gating with
wired or wireless connection.

SIGNA™ Sprint Select uses gating
accessories identical to those of the
predicate device.


Organization
Designation Number and Edition/Date

60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION

ANSI AAMI IEC
60601-1-2: 2014 [Including AMD 1:2021]

Testing to the following voluntary standards included:


GE Medical Systems, LLC
3200 N. Grandview Blvd.
Waukesha, WI 53188

Emily Fang
Regulatory Affairs Leader
609-285-9878
signa.bolt.premarket@gehealthcare.com

Sandra Bahling
Senior Regulatory Affairs Leader
262-720-8872
Sandra.Westphal@gehealthcare.com
Glen Sabin
Regulatory Affairs Director
262-894-4968
Glen.Sabin@gehealthcare.com

Classification Name
Magnetic Resonance Diagnostic Device

Predicate Device(s)
SIGNATM Premier (K193282)

Reference Device(s)
SIGNATM Victor (K223439)

In according with 21 CFR 807.92 the following summary of information is provided:


Specification
SIGNATM Bolt – SuperXG Gradient
SIGNATM Bolt – SuperXF Gradient

3.0T superconducting magnet with a wide (70 cm) bore size and
active shielding

The SIGNATM Bolt system will be offered as two commercial configurations with the following features:


A liquid cooled In-Scan-Room RF transmit architecture with a
peak power capability of 36 kW and 3.0T Platform Body Coil

RF Receive Chain
162 Ch available
130 Ch available

Detachable SIGNA One Patient Table with embedded 3.0T AIR PA
XL coil and up to four 32-channel high density auto-coil sensing
connection ports

Software platform featuring various productivity enhancement
features, designed to improve workflow and reduce scan time
• AIRx (previously cleared in K183231) – AI-based
automated slice prescription tool now extended with new
deep learning models for spine and prostate imaging
• SIGNA One Camera – Real-time AI-enabled image
guidance that assists with automated patient positioning

Wired, wireless, and contactless physiological gating options

Traditional 510(k) Premarket Notification


Subsystem or
Predicate Device
Proposed Device
Comments

3.0T superconducting magnet with active shielding.

Identical. SIGNATM Bolt uses the same
type of magnet as used in the
predicate device.

HRMW gradient coil with
water-cooled, active-
shielded design.

ZRMW gradient coil with
water-cooled, active-
shielded design.

Substantially Equivalent. The ZRMW
gradient coil decreases heat
generation and lowers the
temperature of the inner bore.
These differences do not impact
safety or efficacy.

A liquid cooled RF
transmit architecture
with a peak power
capability of 30 kW and
3.0T RF body coil.

A liquid cooled In-Scan-
Room RF transmit
architecture with a peak
power capability of 36
kW and 3.0T Platform
Body Coil.

Substantially Equivalent. The
Platform Body Coil used in SIGNATM
Bolt is the same as the predicate
device with design modifications to
reduce heat dissipation. SIGNATM
Bolt also uses a newly designed In-
Scan-Room (ISR) Transmit Driver
which moves all the transmit driver
components except the ISR Support
Unit inside the scan room as
compared to the equipment room
for the predicate device. These
modifications do not raise any new
concern of safety or effectiveness.

3.0T Digitize-Per-Pin (DPP) receive chain architecture.

Identical. SIGNATM Bolt uses the same
type of RF receive subsystem as used
in the predicate device.

Respiratory peripheral
and cardiac gating with
wired and wireless
connection. Contactless
peripheral cardiac and
respiratory gating.

Substantially Equivalent. SIGNATM
Bolt offers the same wired and
wireless gating capabilities as the
predicate device. SIGNATM Bolt
introduces contactless gating,
enabling peripheral cardiac and
respiratory triggered MR exams
without the need for physical
attachment of monitoring
accessories. This modification does
not raise any new
concern of safety or effectiveness.

Comprehensive suite of software features, pulse
sequences, and image processing applications to
support MR imaging of all anatomies.

Substantially Equivalent. SIGNATM
Bolt software is based off that of
reference device SIGNATM Victor,
bringing additional parity with
features available on the predicate
device software platform along with
modifications and enhancements to
existing features. The modifications
do not raise any new concern of
safety or effectiveness.


Lunit Inc.
4-8 F, 374, Gangnam-daero, Gangnam-gu,
Seoul, 06241, Republic of Korea
Tel: + 82-2-2138-0827
Fax: +82-2-6919-2702

Hyeseung Yoo,
Sr. Regulatory Affairs Specialist
Email: hsyoo@lunit.io

Juyoung Jung,
Regulatory Affairs Specialist
Email: jjyoung@lunit.io
Sulgue Choi
Regulatory Affairs Team Leader
Email: sulgue@lunit.io


Radiological Computer-Assisted Detection And Diagnosis Software


Lunit INSIGHT DBT v1.2
Lunit INSIGHT DBT v1.1

Radiological Computer Assisted
Detection/Diagnosis Software For Suspicious
Lesions For Cancer

Lunit INSIGHT DBT is a computer-assisted
detection and diagnosis (CADe/x) software
intended to be used concurrently by
interpreting physicians to aid in the detection
and characterization of suspected lesions for
breast cancer in digital breast tomosynthesis
(DBT) exams from compatible DBT systems.
Through the analysis, the regions of soft
tissue lesions and calcifications are marked
with an abnormality score indicating the
likelihood of the presence of malignancy for
each lesion. Lunit INSIGHT DBT uses screening
mammograms of the female population.
Lunit INSIGHT DBT is not intended as a
replacement for a complete interpreting
physician’s review or their clinical judgment
that takes into account other relevant
information from the image or patient
history.

Target patient
Women undergoing mammography
Women undergoing mammography

Physicians interpreting screening
mammograms

Lunit INSIGHT DBT is powered by artificial
intelligence/machine learning-based software
algorithm


Company Name
Harrison-AI Medical Pty Ltd

Level P, 24 Campbell Street
Sydney, NSW 2000
Australia


Manufacturer Name
Harrison-AI Medical Pty Ltd

Radiological computer aided triage and notification software
(21 CFR 892.2080)


Characteristics
Subject Device (Annalise Enterprise)
Predicate Device (Rapid NCCT
Reference Device (Aidoc BriefCase,

Intended context
Annalise Enterprise is a device designed
to be used in the medical care
environment to aid in triage and
prioritization of studies with features
suggestive of the following findings:
• acute infarct*
*See Additional Information below.
The device analyzes studies using an
artificial intelligence algorithm to
identify findings. It makes study-level
output available to an order and imaging
management system for worklist
prioritization or triage.
The device is not intended to direct
attention to specific portions of an image
and only provides notification for
suspected findings.
Its results are not intended:
• to be used on a standalone basis for
clinical decision making
• to rule out specific findings, or
otherwise preclude clinical
assessment of non-contrast
computed tomography brain
Intended modality
Annalise Enterprise identifies suspected
findings in non-contrast brain CT
studies.
Intended user
The device is intended to be used by
trained clinicians who are qualified to
interpret CTB studies as part of their
scope of practice.
Intended patient population
The intended population is patients who
are 22 years or older.
Additional information
The device includes acute infarct of the
cerebral hemispheres or cerebellum, also
including early signs of acute middle
cerebral artery (MCA) infarct such as

Rapid NCCT Stroke is a radiological
computer aided triage and notification
software indicated for use in the
analysis of (1) nonenhanced head CT
(NCCT) images. The device is
intended to assist hospital networks
and trained clinicians in workflow
triage by flagging and communicating
suspected positive findings of (1) head
CT images for Intracranial
Hemorrhage (ICH) and (2) NCCT
large vessel occlusion (LVO) of the
ICA and MCA-M1.
Rapid NCCT Stroke uses an artificial
intelligence algorithm to analyze
images and highlight cases with
detected (1) ICH or (2) NCCT LVO on
the Rapid server on premise or in the
cloud in parallel to the ongoing
standard of care image interpretation.
The user is presented with notifications
for cases with suspected ICH or LVO
findings via PACS, email or mobile
device. Notifications include
compressed preview images that are
meant for informational purposes only,
and are not intended for diagnostic use
beyond notification.
The device does not alter the original
medical image, and it is not intended to
be used as a primary diagnostic device.
The results of Rapid NCCT Stroke are
intended to be used in conjunction with
other patient information and based on
professional judgment to assist with
triage/prioritization of medical images.
Notified clinicians are ultimately
responsible for reviewing full images
per the standard of care. Rapid NCCT
Stroke is for Adults only.
Cautions:
• All patients should get adequate
care for their symptoms
including CTA and/or other
appropriate care per the standard
clinical practice, irrespective of
the device output.
• The device is not intended to be a
rule-out device and for cases that
have been processed by the
device without notification for
“Suspected LVO” should not be
viewed as indicating that LVO is
excluded. All cases should
undergo CTA, per the standard
stroke workup.

BriefCase is a radiological computer
aided triage and notification software
indicated for use in the analysis of
head CTA images in adults or
transitional adolescents aged 18 and
older. The device is intended to assist
hospital networks and appropriately
trained medical specialists in workflow
triage by flagging and communication
of suspected positive findings of
complete Large Vessel Occlusion
(LVO) - MCA-M1, PCA-P1, ACA-
A1, ICA, Basilar; and Medium Vessel
Occlusions (MeVO) - MCA-M2,
MCA-proximal M3, PCA-P2, PCA-
proximal P3, ACA-A2, ACA-proximal
A3, and Vertebral-V4.
BriefCase uses an artificial intelligence
algorithm to analyze images and
highlight cases with detected findings
on a standalone desktop application in
parallel to the ongoing standard of care
image interpretation. The user is
presented with notifications for cases
with suspected findings. Notifications
include compressed preview images
that are meant for informational
purposes only and not intended for
diagnostic use beyond notification.
The device does not alter the original
medical image and is not intended to
be used as a diagnostic device.
The results of BriefCase are intended
to be used in conjunction with other
patient information and based on their
professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of
care.


insular ribbon sign and disappearing
basal ganglia sign.
The infarct must be a completed infarct
(i.e. include an ischemic core of ≥5mL).
The device also includes hyperdense
artery in the anterior circulation but does
not include lacunar infarcts, brainstem
infarcts or venous infarcts.
The radiological device definition of
acute infarct includes the following
territories and regions:
• anterior cerebral artery (ACA)
• middle cerebral artery (MCA)
• posterior cerebral artery (PCA)
• cerebellum
• basilar artery occlusions
• watershed regions
Specificity may be reduced in the
presence of infarcts of <5mL.
Caution:
• All patients should get adequate
care for their symptoms, including
advanced imaging (e.g., CTA,
CTP, MRI, etc.) and/or other
appropriate care per standard
clinical practice, irrespective of the
device output.
• The device is not intended to be a
rule-out device and for cases that
have been processed by the device,
an absence of a notification for
suspected acute infarct should not
be viewed as indicating that acute
infarct is excluded..
Limitations:
• The device does not replace the
need for advanced imaging in the
stroke workup. It provides
workflow prioritization and
notification only.

Limitations:
• Rapid NCCT Stroke does not
replace the need for CTA or
MRA in ischemic stroke workup,
it provides workflow
prioritization and notification
only.
• Rapid ICH has been shown to
reliably identify hemorrhages of
≥ 0.4ml.
Contraindications/Exclusions
• Patient Motion: excessive motion
leading to artifacts that make the
scan technically inadequate.
• Hemorrhagic Transformation,
Hematoma
• Very thin or no Ventricles

Adults or transitional adolescents aged
18 and older

Intended user
and clinical use
environment

Trained clinicians who, as part of their
scope of practice, are qualified to
interpret brain CT scans

Hospital networks and trained
clinicians

Hospital networks and appropriately
trained medical specialists


Acute infarct of the cerebral hemispheres
or cerebellum, also including early signs
of acute middle cerebral artery (MCA)
infarct such as insular ribbon sign and
disappearing basal ganglia sign.
The infarct must be a completed infarct
(i.e., include an ischemic core of ≥5mL).
The device also includes hyperdense
artery in the anterior circulation but does
not include lacunar infarcts, brainstem
infarcts or venous infarcts.
The radiological device definition
includes the following territories and
regions:
• Anterior cerebral artery (ACA)
• Middle cerebral artery (MCA)
• Posterior cerebral artery (PCA)
• Cerebellar regions
• Basilar artery occlusion
• Watershed regions

(Comparison made to only LVO
portion of device)
Large vessel occlusions within the ICA
and MCA-M1, identified by
hyperdense vessel sign

Large Vessel Occlusion (LVO) -
MCA-M1, PCA-P1, ACA-A1, ICA,
Basilar; and Medium Vessel
Occlusions (MeVO) - MCA-M2,
MCA-proximal M3, PCA-P2, PCA-
proximal P3, ACA-A2, ACA-proximal
A3, and Vertebral-V4

Device input and
radiological
image protocol

DICOM-compliant non-contrast brain
CT scans
Attributes model: Determines which
series the algorithm processes based on
pixel data to maximize the proportion of
series that are appropriately analyzed by
AI

DICOM-compliant head CTA scans
aiOS: Determines which series the
algorithm processes based on pixel
data to maximize the proportion of
studies that are appropriately analyzed
by AI

Device output
and means of
notification to
user

Notifications via customizable
workflows into existing systems (e.g.,
PACS, RIS, TigerConnect, Epic, etc.).
A non-diagnostic viewer, where users
can preview DICOM image series, is
provided. This viewer is for
informational purposes only.

Notifications via PACS, email, or
mobile device
A non-diagnostic viewer, where users
can preview DICOM image series, is
provided. This viewer is for
informational purposes only.

Notifications via Aidoc Desktop
Application, a dedicated tool requiring
new workflows and integrations.
A non-diagnostic viewer, where users
can preview DICOM image series, is
provided. This viewer is for
informational purposes only.

Software architecture (Integration
Adapter and Backend API services)
handles image transmission,
storage/security management and output
to medical worklist software.

AI/ML SaMD within the Rapid
Platform including DICOM
processing, job management, imaging
module execution and imaging output
including the notification and
compressed image.

(1) Aidoc Hospital Server
(AHS/Orchestrator) for image
acquisition; (2) Aidoc Cloud Server
(ACS) for image processing; and (3)
Aidoc Desktop Application for
workflow integration

Prioritization
relationship to
standard of care
workflow

Operates parallel to and independent of
the current clinical workflow
(No cases are removed from the
worklist)

Performance
level – Sensitivity
and Specificity

Operating point 1:
Se: 63.5% (95% CI: 54.4, 71.7)
Sp: 95.1% (95% CI: 89.1, 97.9)
(For LVO indication only one
operating point reported)


Characteristics
Subject Device (Annalise Enterprise)
Predicate Device (Rapid NCCT
Reference Device (Aidoc BriefCase,

Triage
effectiveness
performance
level – Turn-
around time


Characteristic
Benefit of difference
Risk of difference and mitigations

Modality: NCCT
same as Rapid
NCCT Stroke but
different from
Aidoc (CTA)

In some advanced stroke imaging centers, CTA and CT perfusion may
be performed immediately after NCCT, while the patient is still on the
scanner table. However, AHA/ASA guidelines recommend
interpretation of NCCT and determination of IV-tPA eligibility and,
where indicated, immediate administration prior to advanced imaging
to determine candidacy for endovascular treatment (Powers, et al.,
2019).
For facilities following the steps recommended by these guidelines,
prioritization and time savings based on the initial NCCT is critical.
Furthermore, care coordination is dependent on the acquisition of
CTA/CTP images. If notification can be initiated earlier, this could help
speed up surgical preparation teams and communication of the
impending patient to specialist teams.

NCCT is a less advanced imaging modality than
CTA and based on literature it could be expected that
infarct detection on NCCT would have much poorer
performance. However, the infarct cases of the
pivotal study were ground truthed with availability
of advanced imaging modality data. There are
multiple operating points that exceeded the typical,
but not prescriptive, 80% sensitivity/80% specificity
bar in triage devices.

Territory
coverage: more
comprehensive
than Rapid NCCT
Stroke but similar
to Aidoc Briefcase

Territories and regions compared to Rapid (primary predicate):
• According to the 2019 Update to the Guidelines for the Early
Management of Acute Ischemic Stroke, mechanical
thrombectomy may be considered in LVO patients outside of the
ICA and M1 segments, including the vessel regions triaged by the
subject device, if treatment can be initiated within 6 hours of
symptom onset.
• Given that MCA infarcts due to LVO account for approximately
only 30% of patients with acute ischemic strokes (AIS)
(Lakomkin, et al., 2019) (Rennert, et al., 2019) an additional
~70% of AIS patients are currently not triaged on NCCT by the
Rapid NCCT Stroke device. Furthermore, the clinical benefit of
IV-tPA may be limited in LVO patients (Hassan, 2021), whereas
patients with posterior circulation stroke account for up to 36% of
acute stroke patients receiving IV-tPA treatment (Keselman, et al.,
2020).
In comparison to the Aidoc reference device, the territories and regions
are similarly comprehensive. (The subject device also includes
cerebellum and watershed regions in its Indications for Use.)

The subject device may not be performant in
additional territories or regions (especially the rarer
locations/regions for infarct), but that risk has been
mitigated by subgroup analysis of a sufficient
number of test cases across different territories and
regions.

• Additional benefit compared to Rapid NCCT LVO because of
additional territories and regions, which may result in up to 70%
more AIS patients being triaged based on the literature quoted
above.
• Additional benefit compared to Aidoc BriefCase because triage of
patients with potential ischemic stroke can happen earlier in the
clinical workflow, at least for a subset of patients that may not
receive CTA at the same time as NCCT.

• Lower risk than Rapid because of
demonstrated higher sensitivity (while
maintaining >80% specificity) at all available
operating points.
• Similar risk to Aidoc: While the triage is based
on NCCT (in comparison to CTA or other
advanced imaging which is recognized as
more sensitive in identifying ischemic stroke),
the ground truthing included availability of an
advanced imaging modality. Furthermore,
multiple operating points exceeded 80%
sensitivity/80% specificity.

Benefit/Risk Summary Compared to Predicate and Reference Device


Not immediately allocated to
a stroke workflow due to an
initial missed or delayed
diagnosis

Unsuspected infarct prior to NCCT: A retrospective study within the US that reviewed patient charts over a one-
year period at two separate hospitals, found ~20% of ischemic stroke patients were missed in the emergency
department despite presenting within the appropriate time window for thrombolytic treatment (Arch, et al., 2016).
Suspected infarct prior to NCCT: Even for patients suspected of acute infarct prior to NCCT, not all are
immediately placed on a stroke workflow. For example, a clinician may consider multiple diagnoses when a patient
presents with stroke-like symptoms. The presence of negative and positive neurologic symptoms may lead a
clinician to suspect stroke and multiple other stroke mimics (Boushra & Lui., 2025). The positive predictive value
for infarct is lower in patients who are more stable, for example those who can ambulate and arrive at an emergency
department by personal vehicle. These patients are less likely to be immediately put on a stroke workflow, even if
they present with signs of stroke.

Up to 17% of strokes occur in patients already hospitalized (Cumbler E. , 2015). Inpatients experiencing stroke
have worse outcomes than those who have stroke in the community (Cumbler E. , 2015) (Cumbler, et al., 2014). In
many cases in-hospital strokes are silent and only detected on routine post- operative imaging; symptomatic
presentation is often non-specific and difficult to identify as patients are impacted by anesthesia, other medications
or are intubated (Benesch, et al., 2021). The median time to treatment for in-patient strokes averaged 100 minutes
(vs 76 minutes for community onset) (Zachrison, et al., 2022), and only one in five patients within-hospital stroke
were treated within the recommended 60-minute target, despite already being in a hospital setting (Cumbler, et al.,
2014).

Regional, rural, or low-
income patients

Regional patients also have poorer outcomes and higher in-hospital mortality associated with longer time to
treatment. (Hammond, Luke, Elson, Towfighi, & Maddox, 2020).
An analysis of data from 2009 to 2019 found that hospitals located in low-income and rural communities had a
lower likelihood of receiving stroke certification than hospitals in general communities. When adjusting the model
for population size, it was also discovered that patients in Black, racially segregated communities had the lowest
likelihood of access to stroke-certified hospitals (Shen, Sarkar, & Hsia, 2022).
Another study that looked at data of 5055 US hospitals from 2009 to 2022 found that hospitals in communities with
the greatest level of disadvantage had the lowest likelihood of adopting specialized stroke care services while those
in the most advantaged communities had the highest likelihood. In fact, these were 20% to 42% less likely to
become stroke-certified compared with hospitals near mixed-advantage communities (Shen, Sarkar, & Hsia, 2022).

Patients treated at hospitals
without well-established
stroke protocols

Of the 5533 hospital emergency departments on record in the United States, 56% do not include recognized stroke
centers, with services that can range from comprehensive stroke management to initiation of care before transferring
to a larger hospital (Boggs, et al., 2022).
A 2020-2021 survey of emergency departments participating in the ACEP Emergency Quality Network (E-QUAL)
Stroke Collaborative found that only 67% of respondents had a written acute stroke protocol (Zachrison, et al.,
2022). A hospital without a stroke protocol may not have a well-established process for ensuring appropriate
members of the care team are available, specifically a neuroradiologist is available to read the case as soon as the
image is acquired.

Patients may also experience disparities in stroke care based on the day or time of day of admission. For example,
in a recent US study at an institution with a comprehensive stroke center and over 80,000 patient visits per year,

consider the current state of care for a diverse patient population, as summarized below.


the median door to needle time was 22 minutes longer during night shift vs during day shift (59 min vs 37 min).
When a dedicated stroke team was present, the median door to needle time was 36 min, compared to 51 min when
they were not present (Ganti, et al., 2023). Similar delays may be encountered at some facilities over weekends
when staff are reduced.

There's evidence that many stroke centers do not meet timeline goals for treatment of patients who are identified
as suspected stroke. A recent retrospective cohort study involving AHA ‘'Get With the Guidelines-Stroke”
participating hospitals, reported a median door to DTN time of 65 minutes (IQR, 49-88 minutes) (Man, Xian, &
Holmes, 2020), indicating that the ≤ 60-minute target is unattainable even for those institutions committed to
achieving this goal. Using the American Heart Association Get With The Guidelines-Stroke registry, one study
evaluated 108 913 patients with acute stroke requiring inter-hospital transfer from 1925 hospitals and determined
that the median door-in to door-out time was 174 minutes, despite the current guidelines recommending no more
than 120 minutes at the transferring emergency department. Longer times were associated with groups of patients
such as those over 80 years of age, women, Black, and Hispanic patients (Stamm, et al., 2023).


Finding
Product Code
Slice Thickness
AUC (95% CI)

adjudicator in the case of disagreement. The key results of the study are summarized in the table below.


Finding
Slice Thickness
Operating Point
Sensitivity % (95% CI)
Specificity % (95% CI)


Parameter
Target or reported value and range

Time to image interpretation after
CT acquired

Patients on Code Stroke workflow
• Per AHA/ASA guidelines target value: <=20 minutes (<=45 minutes if interpretation time measured from
ED arrival, but <=20 minutes is the relevant parameter for comparison to the subject device time to
notification)
• Even highly experienced hospitals are reported to exceed the above time goal by 50 minutes (Honig, et
al., 2014).
• The predicate device 510(k) summary K222884 (also on NCCT) makes a comparison to “time to exam
open” for data collected for CTA LVO exams in DEN170073: 58.7 (95% CI: 51.5, 71.2) minutes. Just as
in K222884, it is reasonable to assume that such CTA exams were collected in the context of a code stroke
workflow, and so the elapsed time on the image worklist is a relevant standard of care comparison.
Patients not on Code Stroke workflow
• Target example hospital guideline expectation for STAT workflow: <2 hours
• Combined data for STAT and Routine workflows: National Radiology Data Registry GRID report for
Jan-Sept 2022, generated from data stored in a Qualified Clinical Data Registry (QCDR) for participating
hospitals, reported the following aggregated time: Median (IQR) report TAT*** of 4.7 (2.1-11) hours (the
time when exam was completed until the time the final report was signed) (National Radiology Data
Registry).

The subject device can reduce the time to notification by up to ~1 hour or more, even for patients allocated to a
code stroke workflow. Time savings will vary greatly dependent on the institution, procedures, presenting
condition of the patient.


QMS (also in compliance with 21 CFR
820)

ISO 13485/ EN ISO 13485 – medical device – Quality Management System
(Compliance also help ensured through routine audits as part of the Medical Device
Single Audit Program)

ISO 14971/ EN ISO 14971 - Medical devices — Application of risk management to
medical devices

Software best practices and submission
content

FDA Guidance: Content of Premarket Submissions for Device Software Functions

IEC 62304 - MEDICAL DEVICE SOFTWARE — SOFTWARE LIFE CYCLE
PROCESSES

IEC 62366-1 - medical devices - Application of usability engineering to medical
devices

AAMI TIR 57 - Principles for medical device security—risk management

FDA Guidance: Cybersecurity in Medical Devices: Quality System Considerations
and Content of Premarket Submissions

ISO/IEC 27001 - Information technology — Security techniques — Information
security management systems — Requirements

IEC 82304-1 – Health software - Part 1: General requirements for product safety

DICOM - Digital Imaging and Communications in Medicine

Standalone testing methodology, bias, and
generalizability considerations specific to
certain radiological imaging software
devices

FDA Guidance: Computer-Assisted Detection Devices Applied to Radiology
Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
(utilized for recommendations relevant to CADt including standalone testing)

Multidisciplinary expertise through
product lifecycle, good software
engineering and security, test set
representativeness, data set independence,
reference standards, risk mitigations
tailored to intended use, human-AI team,
clinically relevant testing, user
information, and deployment controls

Good Machine Learning Practice for Medical Device Development: Guiding
Principles (U.S. Food and Drug Administration (FDA), Health Canada, and the
United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)


Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions.

Please provide the device trade name(s).

Please provide your Indications for Use below.

.
xt
T he QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection-mode and
.
transmission-mode images of a patient's breast. The QT Scanner 2000 Model A software also calculates
He
the breast fibroglandular tissue volume (FGV) value and the ratio of FGV to total breast volume (TBV) value
lp
as determined from reflection-mode and transmission-mode ultrasound images of a patient's breast. The
Te
device is not intended to be used as a replacement for screening mammography.
xt
The QT Scanner 2000 Model A is indicated for use by trained healthcare professionals in environments
where healthcareis provided to enable breast imaging in adult patients.

Please select the types of uses (select one or both, as
applicable).


QT Scanner 2000 Model A
QT Scanner 2000 Model A

§892.1560
Ultrasonic pulsed echo imaging system
Class II

Product Code
IYO, ITX, QIH
IYO, ITX, QIH

The QT Scanner 2000 Model A is for
use as an ultrasonic imaging system to
provide reflection-mode and
transmission-mode images of a patient's
breast. The QT Scanner 2000 Model A
software also calculates the breast
fibroglandular tissue volume (FGV)
value and the ratio of FGV to total
breast volume (TBV) value as
determined from reflection-mode and
transmission-mode ultrasound images of
a patient's breast. The device is not
intended to be used as a replacement for
screening mammography.

• Reflection (B-Mode) and
Transmission (Speed of Sound)
Ultrasound
• Displays 2D slice images and
volume data
• No compression – positions breast
in pendulous position within a water
bath

Transducer Configuration
and Orientation

3 Reflection Mode, 1 Transmission
Mode transmitter, and 1 Transmission
Mode Receiver

Same configuration. The orientation of
the transmission transmitter and receiver
are tilted five degrees to improve
incident field alignment.

Both devices share the same basic system layout and operational principles.


Acquires and processes B-mode
(reflection) and speed of sound
(transmission) images of a patient’s
breast

• General Processing
• Implant Processing
• Reprocessing: remove blur,
artifacts, and dark spots
All image processing/reprocessing can
be performed on the device or on an
offboard image processor

• General Processing
• Implant Processing
All image processing can be performed
on the device or on an offboard image
processor.

Outputs DICOM images to a QTviewer
workstation.

Image Views
Coronal, axial, and sagittal
Same

Correlate
Probe
Region of Interest (ROI)
Segment
Linear Measurement
Manual Annotation

Positions patient in the prone position on
exam table with patient’s breast in
pendulous position within an imaging
chamber

Positions patient’s breast in fluid
environment to eliminate need for breast
compression and facilitate transmission
of ultrasound waves.

Positions patient’s breast by use of a
patient positioning system comprised of
breast insert ring, retention rod and
device to align a patient’s breast in
imaging chamber


Indications for Use
Please type in the marketing application/submission number, if it is known. This
1<254001 ?
textbox will be left blank for original applications/submissions.
Please provide the device trade name(s). ?

Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions.

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)
VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

Please provide your Indications for Use below.

Spectrum Dynamics Medical's VERITON system is intended for use by trained healthcare professionals to
aid in the detection, localization, diagnosis, staging and restaging of lesions, diseases, and organ function.
For evaluating diseases and disorders such as cardiovascular disease, neurological disorders, and trauma.
System outcomes can be used to plan, guide, and monitor therapy.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body
or organ (physiology), using the following techniques: whole body and tomographic imaging.
CT: The CT component is intended to produce cross-sectional images of the body by computer
reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different
angles or spiral planes take at different angles.
SPECT+ CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT
images can be corrected for attenuation with the CT images, and can be combined (image registration) to
merqe the patient's ohvsioloqical (SPECT) and anatomical (CT) imaqes.
CZJ
Please select the types of uses (select one or both, as Prescription Use (21 CFR 801 Subpart 0)
D ?
applicable). Over-The-Counter Use (21 CFR 801 Subpart C)


Digital Imaging and Communications in Medicine
(DICOM) Set

62304
Edition 1.1
2015-06
CONSOLIDA
TED
VERSION

Medical Device Software –Software Life Cycle
Processes

Medical devices – Application of risk management to
medical devices

62366-1
Edition 1.1
2020-06
CONSOLIDA
TED
VERSION

Medical devices - Part 1: Application of usability
engineering to medical devices

Medical devices - Symbols to be used with medical
device labels, labelling, and information to be
supplied - Part 1: General requirements


GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
3200 N Grandview Blvd.
Waukesha, WI, 53188, United States

Zahra Ghanian
Email: zahra.ghanian@gehealthcare.com
Phone: +1 (385)866-0594

Tahir Rizvi, Sr. Director of Regulatory Affairs
Email: Tahir.rizvi@gehealthcare.com
Phone: +1 (781)290-6264

Device Trade Name
Automated Aortic Stenosis Software

892.2060 - Radiological computer-assisted diagnostic software for lesions
suspicious of cancer


AutoAS produces a confidence
metric, also known simply as
“confidence”, whenever it
makes a prediction. With this
metric, the algorithm aims to
highly correlate with the true
probability of a successful
binary classification of the
severity of aortic stenosis.

Testing demonstrated a statistically monotonically
increasing relationship between the confidence
value and the probability of accurately detecting
whether moderate / severe aortic stenosis was
present.

Before analysis, AutoAS
evaluates each clip with a clip
annotator. The function of the
clip annotator is to confirm if
the clip is B-mode and part of
“valid” views (such as PLAX,
PSAX-AV etc.) and rejects any
other views.

Testing demonstrated both a positive predictive
value (PPV) and Sensitivity of 100% (95% CI: (98.5%,
100.0%)) across all view types (i.e., PLAX, AP5, PSAX-
AV, and all other views) when classifying the B-mode
image. For any image that was classified as B-mode,
the ability to accurately classify the view was also
tested, and the verification test results revealed a
PPV of at least 97.1% (95% CI: (94.2%, 98.8%)) and a
Sensitivity of at least 87.5% (95% CI: (83.1%, 91.2%))
across all view types.

AutoAS has the ability to predict
a patient’s heart period by
looking solely at the video clip.
The estimated heart rate is not
reported to the user and is used
only internally to the software.

The verification testing demonstrated a statistically
significantly lesser MAD / MAE than the established
benchmark for all views (AP5, PLAX, and PSAX).
Based on these results, there were no clinically
significant differences between the estimated heart
rates by the software and the reference
measurements.


Table 1. Consistency of performance metrics across relevant sub-group parameters


Category
Subject Device
Predicate Device
Discussion

Manufacturer
GE HealthCare
Ultromics Ltd.

AutoAS is a software application intended
to assist medical professionals in the
assessment of moderate/severe aortic
stenosis (AS). The software uses an
artificial intelligence (AI) algorithm to
process previously acquired two-
dimensional transthoracic
echocardiography (2D-TTE) images to
provide a suggestion of moderate/severe
aortic stenosis along with an associated
confidence metric that can be a diagnostic
aid to a physician in a point of care or
similar setting in determining if further
evaluation is needed, including whether a
full echocardiogram (2D, Doppler) needs
to be performed.
The results of AutoAS are not intended to
be used on a stand-alone basis for clinical
decision making and are not intended to
supplement or replace a full
echocardiographic examination. AutoAS
results, along with the obtained
ultrasound images, must be reviewed by a
qualified physician.

EchoGo Pro v1.0.2 is a machine learning-
based decision support system, indicated
as an adjunct to diagnostic stress
echocardiography for patients undergoing
assessment for coronary artery disease
(CAD). When utilized by an interpreting
physician, this device provides information
that may be useful in rendering an accurate
diagnosis. Patient management decisions
should not be made solely on the results of
the EchoGo Pro v1.0.2 analysis. EchoGo Pro
v1.0.2 is to be used with stress echo exam
protocols that contain A2C, A4C, and mid-
ventricular short-axis views at rest and at
peak stress. EchoGo Pro v1.0.2 is not
intended for the assessment of mild or
moderate myocardial ischemia, or
localization of coronary artery disease, or
for the assessment of myocardial perfusion,
myocardial viability, or valve disease.
Limitations: EchoGo Pro v1.0.2 has not
been validated on patients who underwent
previous coronary artery bypass graft
(CABG) surgery.

Similar. Both devices are intended
to be used as diagnostic aids for
cardiac evaluation. Both devices
specify in the indications for use
that patient management should
not be driven solely by the output
of the devices. and both devices
are intended to be used by the
reading physician as part of
patient evaluation i.e., obtained
images must be formally
interpreted and reported by a
qualified physician. Therefore,
both devices are not intended to
replace the skill and judgment of
a qualified medical practitioner.
There is a minor difference in the
specific condition that is being
automatically detected between
the devices, with the predicate
assessing coronary artery disease
(CAD) and the subject device
assessing AS; however, both
devices are designed to operate
within the same anatomical area.

Table 2: Substantial Equivalence Comparison Chart


The AutoAS product is not intended to be
used on patients who have prosthetic
valves and/or have had prior valve repair
or replacement.
AutoAS software is indicated for use in
adult patients and is intended to be an
accessory to compatible ultrasound
systems in environments where
healthcare is provided.

Radiological computer-assisted diagnostic
software for lesions suspicious of cancer

Modality
Ultrasound (Echocardiography)
Ultrasound (Echocardiography)
Identical

Anatomical Site
Cardiovascular
Cardiovascular
Identical

Similar. Despite minor difference
in specific conditions evaluated,
this distinction does not raise new
safety or efficacy concerns as
both clinical conditions are
diagnostic in nature in the same
anatomical site.

While the specific image views
required differ slightly between
the devices, both incorporate
quality-control measures to


ensure sufficient input data and
generate user-facing reports to
support cardiac evaluations.

Substantially equivalent. Both
devices utilize deep-learning
artificial intelligence as the core
technology to provide diagnostic
aid to the user in the assessment
of heart conditions.

Two-level (Binary) Output:
Suggestive of moderate to severe AS
Or
Not suggestive of moderate to severe AS
Confidence score generated at study-level.

Two-level (Binary) Output:
Suggestive of a lower risk of prognostically
significant coronary artery disease
Or
Suggestive of a higher risk of prognostically
significant coronary artery disease.

Both devices process ultrasound
images to generate a two-level
diagnostic output intended to
assist medical professionals. The
subject device includes a
confidence score whereas the
predicate device does not. The
confidence score indicates how
certain the algorithm is in its
prediction, based on the clips
analyzed.
This difference does not raise
safety or efficacy concerns
because the confidence score is
only intended as supporting
information but does not replace
physician responsibility for
diagnosis.

Labelled for
Interpreting
Physician Read

Identical. Both devices do not
replace clinical judgment,
emphasizing that all exams must


Category
Subject Device
Predicate Device
Discussion

be reviewed by an interpreting
reading physician.


Device
Predicate Device:
Subject Device: AiORTA
Comparison

Manufacturer
ViTAA Medical, Inc.
ViTAA Medical, Inc.
Identical

Classification
21 CFR 892.2050
21 CFR 892.2050
Identical

The AiORTA - Plan tool is
an image analysis
software tool for
volumetric assessment.

The AiORTA - Plan tool is
an image analysis
software tool for
volumetric assessment,

Addition of
“patients 22
years old and
older” added to


It provides volumetric
visualization and
measurements based
on 3D reconstruction
computed from
cardiovascular CTA
scans. The software
device is intended to
provide adjunct
information to a licensed
healthcare practitioner
(HCP) in addition to
clinical data and other
inputs, as a
measurement tool used
in assessment of aortic
aneurysm, pre-operative
evaluation, planning and
sizing for cardiovascular
intervention and surgery,
and for post-operative
evaluation.
The device is not
intended to provide
stand-alone diagnosis or
suggest an immediate
course of action in
treatment or patient
management.

image analysis,
geometric analysis, and
pre-operative sizing and
planning. It provides
volumetric visualization
and measurements
based on 3D
reconstruction
computed from
cardiovascular CTA
scans. The software
device is intended to
provide adjunct
information to a licensed
healthcare practitioner
(HCP) in addition to
clinical data and other
inputs, as a
measurement tool used
in assessment of aortic
aneurysm, pre-operative
evaluation, planning and
sizing for cardiovascular
intervention and surgery,
and for post-operative
evaluation in patients 22
years old and older.
The device is not
intended to provide
stand-alone diagnosis or
suggest an immediate
course of action in
treatment or patient
management

intended use &
indications for
use statement
per FDA
recommendation
.

Abdominal aorta +
external iliac arteries

The region of
interest has been
expanded in v2.0

ViTAA Medical Solutions, Inc. K254207: AiORTA – Plan v2.0 510(k) Summary


and a larger portion of
the descending aorta

to give clinicians
better ability to
assess access
vessels and
supra-renal
considerations.
This expansion of
ROI does not
introduce new
questions of
safety or
effectiveness.

Semi-automatic analysis
pipeline requiring input
from ViTAA analysts.
Analysis is completed
within 30 minutes under
normal conditions.

Fully automated
analysis pipeline.
Clinicians retain the
ability to edit outputs.

A full suite of
image analysis
tools for manual
correction by a
clinician has
been added. All
corrections and
edits are
performed by the
physician.

Provides tools for
measuring vessel
geometry, including
diameters, lengths, and
volumes.

All relevant
measurements are
provided automatically,
along with a detailed
breakdown targeting
landing zones and other
critical regions of
interest.

Additional tools
are provided to
guide the user,
while users can
still edit or
override the
automated
outputs.

Semi-automatic
segmentation using
auto-masking algorithm
with manual revisions

Automated
segmentation using
masking algorithm. The
end-user (clinician) can

Users in v2.0
have the option
of employing an
automated


Device
Predicate Device:
Subject Device: AiORTA
Comparison

performed by trained
ViTAA analysts. End-
users (clinicians) can
view and edit the
segmentations.

view and edit these
segmentations using the
included suite of editing
tools.

algorithm instead
of a ViTAA analyst
for segmentation.
Clinicians retain
control over the
end result.

Automatic centerline
detection within the
analysis pipeline. User
edits of the centerline
are not supported.

Allows users to visualize
two studies side-by-side
across two viewports,
enabling a direct
comparison of
structures between the
studies.
Provides measurement
capabilities in
comparison mode,
allowing users to
quantify changes in
vessel geometries
between the two
studies. Provides device
suggestions to the user
based on product tables
provided by the
institution, using
clinically-validated
measurements.

Version 2.0
contains the
addition of
device
suggestions
based on look-up
tables provided
by the institution.
This additional
helpful
information does
not raise new
questions of
safety or
effectiveness.

Reports automated
measurements
describing changes
between two studies
within the default
volume of interest,
including:

All previous calculations
with the addition of C-
ARM calculations for
proximal neck and distal
left and right common
iliac arteries.

Additional
calculations in
the v2.0 device
are included to
accommodate
the expanded
ROI.


• Change in
Maximum Lumen
Diameter
• Change in
Maximum Aortic
Diameter
• Change in
Lumen Volume
• Change in Aortic
Volume

• Report in PDF
format
• Viewports:
Session state

• Lock viewports
• Switch to
single/quad view
• Take screenshot
• Show/hide slice
plane

• Pan
• Window
• Level
• Scroll slice
• Zoom

• Rotate
(clockwise,
counterclockwise
, free rotate)
• Pan
• Zoom


Device Name,
Aquilion ONE (TSX-308A/TSX-306A)
Aquilion Serve SP (TSX-307B/1) V1.3
Aquilion Serve SP (TSX-307B/1) V1.3

Body and Lung scan reconstruction
capabilities

N/A – feature not available, but previously
cleared under K242403.

Cardiac, Body, and Lung scan
reconstruction capabilities


Proprietary Name
Bunkerhill Contrast CAC

Classification Name
Computed tomography x-ray system


Reference: Device:
Bunkerhill AVC (K243229)

Bunkerhill Contrast
Bunkerhill iCAC Device

Bunkerhill Contrast CAC
is a software device
intended for use in
detecting presence and
estimating quantity of
coronary artery
calcification for adult
patients aged 30 years and
above. The device
automatically analyzes
non-gated, contrast-
enhanced chest computed
tomography (CT) images
collected during clinical
care and outputs the region
of interest (intended for
informational purposes
only) and quantification of
detected calcium.
The output of the subject
device is made available to
the physician on-demand
as part of his or her
standard workflow. The
device-generated
quantification can be
viewed in the patient
report at the discretion of
the physician, and the
physician also has the
option of viewing the
device-generated calcium
region of interest in a
diagnostic image viewer.
The subject device output
in no way replaces the
original patient report or
the original non-gated,
contrast-enhanced CT
scan; both are still

iCAC is a software
device intended for use
in estimating presence
and quantity of coronary
artery calcium for
patients aged 30 years
and above during routine
care. The device
automatically analyzes
non-gated, non-contrast
chest computed
tomography (CT) images
collected during routine
care and outputs a visual
representation of
estimated coronary artery
calcium segmentation
(intended for
informational purposes
only) and both exact and
four-category
quantitative estimates of
the patient’s coronary
artery calcium burden in
Agatston units.
The output of the subject
device is made available
to the physician on-
demand as part of his or
her standard workflow.
The device generated
calcium score or score
group can be viewed in
the patient report at the
discretion of the
physician, and the
physician also has the
option of viewing the
device-generated calcium
segmentation in a

Bunkerhill AVC is a
software device intended for
use in detecting presence
and estimating quantity of
aortic valve calcification for
adult patients aged 40 years
and above. The device
automatically analyzes non-
gated, non- contrast chest
computed tomography (CT)
images collected during
clinical care and outputs the
region of interest (intended
for informational purposes
only) and quantification of
detected calcium.
The output of the subject
device is made available to
the physician on- demand as
part of his or her standard
workflow.
The device-generated
quantification can be
viewed in the patient report
at the discretion of the
physician, and the
physician also has the
option of viewing the
device- generated calcium
region of interest in a
diagnostic image viewer.
The subject device output
in no way replaces the
original patient report or the
original non- gated, non-
contrast CT scan; both are
still available to be viewed
and used at the discretion of
the physician.

Table 1: Substantial Equivalence-Intended Use Table


diagnostic image viewer.
The subject device output
in no way replaces the
original patient report or
the original chest CT
scan; both are still
available to be viewed
and used at the discretion
of the physician.
The device is intended to
provide information to the
physician to provide
assistance during review
of the patient’s case.
Results of the subject
device are not intended to
be used on a stand-alone
basis and are solely
intended to aid and
provide information to the
physician. In all cases,
further action taken on a
patient should only come
at the recommendation of
the physician after further
reviewing the patient’s
results.

The device is intended to
provide information to the
physician to provide
assistance during review of
the patient’s case.
Results of the subject device
are not intended to be used on
a stand- alone basis and are
solely intended to aid and
provide information to the
physician. In all cases, further
action taken on a patient
should only come at the
recommendation of the
physician after further
reviewing the patient’s
results.


Proposed Device:
Bunkerhill Contrast CAC

Reference Device:
Bunkerhill AVC
(K243229)

Regulation number
21 CFR §892.1750
21 CFR §892.1750
21 CFR §892.1750
Same

Contrast-enhanced, Non-
cardiac-gated CT scan

Non-contrast, Non-
cardiac-gated CT scan

Slice thickness
Up to 5 mm
Up to 5 mm
Up to 5 mm
Same

Visual output in the form a
Region of Interest or ROI
(intended for informational
purposes only). The
estimated visual output can

Outputs a visual
representation of
estimated coronary
artery calcium
segmentation (intended

aspect of the subject device is most similar to the reference device.