Conclusion
(Function/ User
interface/
Workflow)

In 2D Viewer mode operator can review
original axial images as acquired by the
scanner.

Identical.
Therefore,
substantially
equivalent.

Use the MPR mode to view three-plane
orthogonal images. In this mode, the three
shown planes can be easily correlated.
Three orthogonal cut planes are shown:
• Axial Orientation
• Coronal Orientation
• Sagittal Orientation

The volume mode is used to display CT
scanner data in a full volume image. It
provides basic tools for image editing and
generation of cine movies.


The CT Endo viewer is a review function
that allows you to perform a general
flythrough of any suitable anatomical
structure that is filled with air or with
contrast material, including general vessels,
cardiac vessels, the bronchus, and the
colon.

The Image Matrix parameter sets the
number of pixels that the reconstructed
image will contain. Select 512, 768, or
1024.

O-MAR stands for orthopedic metal artifact
reduction. This post processing capability
reduces metal induced artifacts and is
directed for large orthopedics metals that
cause photon starvation of the rays that
pass through the metal object.

DoseRight Index (DRI) is according to the
current scan site and body size of the
patient, the mAs suitable for the patient is
automatically recommended, so that the
image quality can meet the requirements of
the diagnosis, and the radiation dose of the
patient can be reduced as far as possible.

DOM combines angular and longitudinal
information to modulate dose in three
dimensions. Personalizes dose for each
patient by automatically suggesting tube
current settings according to the estimated
patient diameter in the scan region. Angular
dose modulation varies the tube current
during helical scans according to changes
in patient shape (eccentricity) and tissue
attenuation as the tube rotates.

Precise Planning can automatically adjust
the scan range of subsequent Axial or
Helical scan series, based on the Surview
Image.

Support the adjustment of sagittal / coronal
image construction in the planned scanning
phase, and finally obtain the adjusted tilted
multiplane image.
On the basis of Insert MPR, surface
reconstruction is carried out by interpolation
of axial image and corresponding tilted
image is generated.

Yes
(It is called
“Insert MPR” in
predicate
device)


OnPlan is a gantry operational touch panel
located on both sides of the gantry. The
OnPlan gantry controls are used to activate
the laser marker, controls patient table
movements, display patient information and
images, and conduct a new patient exam.

Precise Spine application enables the
system to assist the user to identify the
lumbar disk space automatically and create
a batch based on the protocol selected.

Precise Brain application for a series of
brain tissue slices that are parallel or
vertical in the plane of the cranial CT scan.

The Bolus tracking function maximizes the
efficiency of CT scans that are enhanced
through the use of a contrast agent. This is
done by preceding the Clinical scan with
Locator and Tracker scans.

This feature enables the usage of the
injector scan trigger.

The Filming application is used for viewing,
rearranging, windowing and zooming
images prior to sending them to be printed.

Identical.
Therefore,
substantially
equivalent.

The Worklist displays patient information
provided by the HIS/RIS.

If the patient is from the Worklist and the
MPPS function is enabled, feedback
regarding the study status of the patient can
be sent to the hospital HIS/RIS.

The Reporting package allows you to create
customized reports using pre-formatted
templates.
A template is a specially designed
formatting document that places the
analytical information and images that you
send from an application into an organized
report which can be printed and saved.

Continuous CT (CCT) is a scanning mode
that allows the physician to perform


extended, low-dose scans while performing
a biopsy.
The resulting images are displayed on a
remote monitor in the scan room, providing
visual feedback during the biopsy.

Brain Perfusion is a blood flow imaging
application that analyzes the uptake of
injected contrast in order to determine
perfusion-related information about one or
more regions of interest.

Dental applications are used to create true-
size (life size) film images of the mandible
and maxilla for assisting oral surgeons in
planning implantation of prostheses. Using
a special dental planning procedure, the
images will be created from this scan which
can be input into the Dental planning
application.

iDose4 is an iterative reconstruction
technique that improves image quality
through artifact prevention and increased
spatial resolution at low dose.

Helical retrospective cardiac scanning
enables the system to acquire a volume of
data while the patient’s ECG is recorded.
The acquired data is tagged and
reconstructed retrospectively at any desired
phase of the cardiac cycle.

Axial
Prospective
Gating
calcium
scoring

Axial prospective gating uses an external
ECG gating system to synchronize
individual axial scans with the patient’s
heartbeat. The ECG-triggered scans
significantly minimize heart-motion artifacts.

Step & Shoot Cardiac provides high quality
CT images of the coronary arteries and
heart anatomy at very low radiation dose
levels. During Step & Shoot Cardiac, X-rays
are generated only during the cardiac phase
of interest.

The Cardiac Calcium Scoring application is
used to quantify the buildup of calcium
plaque on the walls of the patient's coronary
arteries and other relevant locations. The
potential calcifications are highlighted by the
application during launch.

Precise image reconstruction is a recon
mode where the system uses a trained
deep learning neural network to generate
noise reduction images compared with
standard FBP recon mode for adult
patients only. Precise Image has not been

Same AI/ML
image recon
algorithm,
modified with new
models to enable
the reconstruction


validated for lung cancer screening
indications.

of a new organ
type (cardiac),
support more slice
thicknesses, a
new scan mode
(high resolution
head), and more
clinical scenarios
for body and
head.
No change to
algorithm
architecture
compared to
predicate device,
therefore,
substantially
equivalent.

Precise Cardiac is a reconstruction
technique with the potential to
provide compensation for cardiac motion.

Identical.
Therefore,
substantially
equivalent.

Precise Position is a camera-based
workflow designed to assist with positioning
the patients aged 16 years and older
automatically from console or OnPlan, it
can:
•automatically select patient orientation.
•automatically set vertical centering &
positioning of the patient to the Surview
start and end positions.
•support editing Surview start & end range
and scan direction.

Same AI/ML
algorithm,
modified to
support more
exams (cardiac,
spine, runoff).
No change to
algorithm
architecture
compared to
predicate device,
therefore,
substantially
equivalent.

In Precise Intervention viewer there are
several tools, they will help you to navigate
the needle safely during the intervention.

Same
interventional
feature as
predicate device.
To duplicate one
additional
Interventional
controls panel
from couch side to
a mobile cart for
convenience.
There is no
change to SW
algorithm


compared to
predicate device.
Therefore,
substantially
equivalent.

Direct Result-With Direct Result the user is
able to choose a desired result during scan
planning phase and get the result for
diagnosis without
further intervention.

The system support Parallel workflow using
Dual monitor as below:
- main monitor: Patients, scan, service,
"show all" for scan planning, Help.
- extend monitor: Completed, viewers,
Analysis, recon, filming, report

CT Colonoscopy (CTC) application enables
fast and easy visualization of colon scans,
using acquired CT images.

Vessel Analysis (VA) offers a set of tools for
general vascular analysis. With VA the user
can easily remove bone, and extract
vessels. Users also can perform
measurements such as intraluminal
diameter, cross-sectional lumen area,
length.

The Lung Nodule Analysis (LNA)
application assists the radiologist with the
detection and quantification of pulmonary
nodules and lesions.

The Coronary Artery Analysis provides
viewing and measuring tools that allow you
to perform dimensional and quantitative
measurements of the coronary arteries to
help you identify and examine the patient
study for stenosis.

Cardiac Function Analysis (CFA) application
is used to assess the state of the left
ventricle (LV) and to analyze functional
heart data.

Dual energy Viewer is an application for
review and analysis of CT dual-energy
scans. Users need to load CT dual-
energy scan data which is two series
with similar KV. It provides registration
function and can generate different


weighted KV images. Users can use the
tools to separate materials.

The CT 5300 system design, intended use, technology and principal
technological components (Tube, Generator, Detector) of the proposed
device are substantially equivalent to the currently marketed predicate
device Philips Incisive CT (K212441 - April 27, 2021). Based on the
information provided above, the proposed device with modifications does
not raise new questions of safety and effectiveness compared to the
currently marketed predicate device Philips Incisive CT (K212441 - April
27, 2022).


Predicate Device
FDA Clearance Number and
Product
Manufacturer

Reference Device
FDA Clearance Number and
Product
Manufacturer

equivalent to the following predicate device:


Subject Devices
Predicate Device
Reference Devices

MAGNETOM Avantofit
MAGNETOM Vida with
MAGNETOM Avantofit

MAGNETOM Skyrafit
syngo MR XA50A
MAGNETOM Skyrafit with

with software syngo MR
(K213693)
syngo MR VE11E1

Summary hardware comparison table for the subject and predicate/reference device


GRE-based/Steady-State pulse
- GRE_PC new pulse sequence

sequence types
- BEAT_NAV pulse sequence re-

EPI-based pulse sequence types
- Physiologging for EPI2D_BOLD

Spectroscopy pulse sequence types
Yes
Yes

Other features and
Modified application feature:
Yes

applications such as:
- myExam Angio Assist (Test Bolus

-Application Suites
and Care bolus) for MAGNETOM

User interface and user interaction
Yes
Yes

Workflow and software utilization
Yes
Yes


Performance Test
Source/Rationale for test

Guidance for the Content of Premarket
Submissions for Software Contained in
Medical Devices

New or modified software
features and coils

Guidance for submission of Premarket
Notifications for Magnetic Resonance
Diagnostic Devices

Image quality
assessment by sample
clinical images

- new / modified pulse
sequence types.
- comparison images
between the new / modified
features and the predicate
device features

The following performance testing was conducted on the subject devices:


Performance Test
Tested Hardware or Software
Source/Rationale for test

- SNR and image uniformity
measurements for coils
- Heating measurements for coils

Guidance for Submission of
Premarket Notifications for
Magnetic Resonance Diagnostic
Devices

reference devices and can be reused for the subject devices:


[1] Guenthner C. et al. Ristretto MRE: A generalized multi-
shot GRE-MRE sequence. NMR Biomed 2019; 32:e4049.

of the following features and functions:


Characteristic/Parameter
Brainomix 360 Triage Stroke
iSchemaView Rapid NCCT Stroke

Subject Device (K232496)
Predicate Device (K222884)

with the Rapid NCCT Stroke device (K222884).


Metrics
21 < Age < 50
50 ≤ Age < 70
Age ≥ 70


Metrics
SIEMENS
GE MEDICAL SYSTEMS
Philips


Classification Name
21 CFR §
Product Code

Ultrasonic pulsed doppler imaging
system

Diagnostic ultrasonic transducer
892.1570
ITX

Medical image management and
processing system

Common Name: Diagnostic ultrasound system and transducers


There is no change to the intended use and indications for use of the subject device as compared to the

currently commercialized version of Lumify Diagnostic Ultrasound System, except lung indication

was added through K203406 for Lumify Diagnostic Ultrasound System with B-line Detection and B-

line Counting, and Pulsed Wave Doppler was added during Lumify 4.0 (Android) release through a

The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in

B(2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler, and M-modes.

It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:

Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small

Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung.

The Lumify system is a transportable ultrasound system intended for use in environments where

healthcare is provided by healthcare professionals.

The intended use of the product is to collect ultrasound image data that may be used by clinicians for

diagnostic and procedural purposes. The product shall provide the ability for gathering clinically

acceptable images and ultrasound data for the clinical presets and anatomies listed under the

This product is intended to be installed, used, and operated only in accordance with safety procedures

and operating instructions given in the product user information, and only for the purposes for which

it was designed. However, nothing stated in the user information reduces the user’s responsibility for

sound clinical judgement and best clinical procedure.


DiA LVivo
Software
Application
K210053
(Reference Device)

System, Imaging,
Pulsed Doppler,
Ultrasonic

Automated
Radiological
Imaging Processing
Software

Device Classification
II
II
II
Remains unchanged

Remains unchanged
from predicate
Lumify Ultrasound
System
QIH is a secondary
product for subject
device

Not Applicable
This feature was
not available with
this version

LVivo software
application has been
incorporated in
Lumify Ultrasound
System as Auto EF
Quantification

Relies on
Ultrasound imaging
to perform the
assessment

Remains unchanged
for the predicate and
similar for the
reference

Principles of
Operation (subject
Auto EF
Quantification
Feature)

Lumify Auto EF
Quantification is
a software only
feature. The core
system software
architecture
remains
unchanged. This

The LVivo platform
is a software system
for automated
analysis of
ultrasound
examinations.

With Auto EF
Quantification feature
the user is offered an
automated
measurement of
Ejection Fraction
(EF), End Diastolic
Volume (EDV), and


additional feature
is added in the
Cardiac preset of
the Lumify
system to assess
left ventricular
function using a 4
Chamber Apical
view of the heart.
This feature
provides
automated tracing
of the Left
Ventricular (LV)
border and
quantification of
End Systolic
Volume (ESV)
and End Diastolic
Volumes (EDV)
as well as the
Ejection Fraction
(EF) for LV
assessment.

End Systolic Volume
(ESV). The Lumify
features are a subset
of the LVivo platform

Auto EF
Quantification, is
a derivative of the
previously
cleared LVivoEF
module
(K210053) that
enables
automated
evaluation of end
diastolic volume
(EDV), end
systolic volume
(ESV) and
Ejection Fraction
(EF) from the
Four Chamber
(4CH) apical
view.

Automated analysis
of
echocardiographic
examinations is
done based on
ultrasound imaging
data by analyzing
already acquired
clip (cine
loop). The imaging
data can be
provided in DICOM
format that includes
required metadata
or RGB format
together with
metadata that is
provided through
software API. The
global LV function
is evaluated from
two of the apical
views: four-
chamber (4CH) and

The subject device
with the automation
of the Auto EF
Quantification
feature, the user is
now offered
measurements
including Ejection
Fraction (EF), End
Diastolic Volume
(EDV) and End
Systolic Volume
(ESV).
The AL/ML
functionality is same
in the subject device
in comparison to the
reference device.

Lumify Diagnostic Ultrasound System with Auto EF Quantification


DiA LVivo
Software
Application
K210053
(Reference Device)

two-chamber (2CH)
by calculating
ejection fraction
(EF). The LVivo EF
supports global LV
function evaluation
from single view or
Biplane”

Same as the reference
device (DiA LVivo)

Volume calculation
by Simson’s method
of discs

Displaying full
clip with border
tracking. The
results for
selected ED and
ES frames for
default beat is
displayed.

Displaying full clip
with border
tracking. And table
with results for each
cycle for selected
ED & ES frames for
each beat.

Auto EF for Lumify
does not have the
table with results for
each cycle. Only
results for ED & ES
frames for default
beat is displayed.

Image
segmentation for
border detection
and tracking
includes
processing by
neural network

Not Applicable
This feature was
not available with
this version
.


L12-4
S4-1
C5-2
Auto EF is only
available on S4-1
Transducer
(Cardiac Phased
Array)

Auto EF
Quantification feature
is only available on
S4-1 transducer


Thickened
leaflet,
Calcified or
prosthetic
mitral valve

The demographic distribution of the study population includes the following:


Exo AI Platform is a software as a medical device (SaMD) that helps qualified users with

image-based assessment of ultrasound examinations in adult patients. It is designed to simplify

workflow by helping trained healthcare providers evaluate, quantify, and generate reports for


AI Platform takes as an input imported Digital Imaging andCommunicationsinMedicine(DICOM)

images from ultrasound scanners of a specific range and allows users to detect, measure, and

calculate relevant medical parameters of structures and function of patients with suspected

disease. It provides users with a specific toolset for viewing ultrasound images of the lung and


ReferenceDevice
LumifyDiagnostic
UltrasoundSystem
(K223771)


Ultrasoundimage
processingsoftware
implementingartificial
intelligenceincluding
non-adaptivemachine
learningalgorithmstrained
withclinicaldataintended
fornon-invasiveanalysisof
ultrasounddata

DeepConvolutionalNeural
Networksfor
Segmentationor
LandmarkDetection

Manual
Adjustmentsor
EditingbyUser
Allowed

AnatomicalSites Heart,Lungs Heart,Bladder Lungs

Reportcreation Yes Sameassubjectdevice Sameassubjectdevice


XIDF-AWS801, Angio Workstation (Alphenix
Workstation), V9.3

Marketed by
Canon Medical Systems USA, Inc.

Image-intensified
fluoroscopic x-ray system


Predicate Device
FDA Clearance Number and
Product
Manufacturer

Reference Device
FDA Clearance Number and
Product
Manufacturer


MAGNETOM Sola
MAGNETOM Sola with
MAGNETOM Altea with

MAGNETOM Altea
syngo MR XA51A
syngo MR XA51A


Software
MAGNETOM Sola
MAGNETOM Sola with syngo

SE-based pulse sequence types
- Deep Resolve Boost for

EPI-based pulse sequence types
and EP2D_PACE

Summary software comparison table for the subject and predicate devices


Workflow and software utilization
Yes
Yes


• TSE: more than 25,000 slices
• HASTE: pre-trained on the TSE dataset
and refined with more than 10,000
HASTE slices
• EPI Diffusion: more than 1,000,000
slices
The data covered a broad range of body
parts, contrasts, fat suppression techniques,
orientations, and field strength.

on more than 10,000 high resolution 2D
images.
The data covered a broad range of body
parts, contrasts, fat suppression techniques,
orientations, and field strength.

Test Statistics and
Test Results
Summary

The impact of the network has been
characterized by several quality metrics
such as peak signal-to-noise ratio (PSNR)
and structural similarity index (SSIM). Most
importantly, the performance was
evaluated by visual comparisons to
evaluate e.g., aliasing artifacts, image
sharpness and denoising levels.

The impact of the network has been
characterized by several quality metrics
such as peak signal-to-noise ratio (PSNR),
structural similarity index (SSIM), and
perceptual loss. In addition, the feature has
been verified and validated by inhouse
tests. These tests include visual rating and
an evaluation of image sharpness by
intensity profile comparisons of
reconstructions with and without Deep
Resolve Sharp.

No clinical subgroups have been defined for the collected dataset.

Due to reasons of data privacy, we did not record gender, age and ethnicity during data
collection.

The acquired datasets (as described above)
represent the ground truth for the training
and validation. Input data was
retrospectively created from the ground
truth by data manipulation and
augmentation.
This process includes further under-
sampling of the data by discarding k-space
lines, lowering of the SNR level by addition
Restricted of noise and mirroring of k-space
data.

The acquired datasets represent
the ground truth for the training
and validation. Input data was
retrospectively created from the
ground truth by data
manipulation. k-space data has
been cropped such that only the
center part of the data was used
as input. With this method
corresponding low-resolution
data as input and high-resolution
data as output / ground truth
were created for training and
validation.


[1] Bae SH et al., Clinical feasibility of accelerated diffusion
weighted imaging of the abdomen with deep learning
reconstruction: Comparison with conventional diffusion
weighted imaging, Eur J Radiol., 154 (2022)
[2] Lee EJ et al., Feasibility of deep learning k-space-to-image
reconstruction for diffusion weighted imaging in patients
with breast cancers: Focus on image quality and reduced scan
time, Eur J Radiol., 157 (2022)
[3] Afat S et al., Acquisition time reduction of diffusion-
weighted liver imaging using deep learning image
reconstruction. Diagn Interv Imaging, (2022).
[4] Benkert T et al., Improved Clinical Diffusion Weighted
Imaging by Combining Deep Learning Reconstruction, Partial
Fourier, and Super Resolution, ISMRM (2022)
[5] Kim et al., Deep Learning–Accelerated Liver Diffusion-
Weighted Imaging - Intraindividual Comparison and
Additional Phantom Study of Free-Breathing and Respiratory-
Triggering Acquisitions, Invest Radiol (2023)

[1] Herrmann J et al., Diagnostic Confidence and
Feasibility of a Deep Learning Accelerated HASTE Sequence of
the Abdomen in a Single Breath-Hold, Investigative
Radiology, Volume 56, Number 5, May 2021.
[2] Shanbhogue K et al. Accelerated single-shot T2-
weighted fat-suppressed (FS) MRI of the liver with deep
learning-based image reconstruction: qualitative and
quantitative comparison of image quality with conventional
T2-weighted FS sequence. Eur Radiol. 2021 May 7.
[3] Herrmann J et al., Development and Evaluation of
Deep Learning-Accelerated Single-Breath-Hold Abdominal
HASTE at 3 T Using Variable Refocusing Flip Angles. Invest
Radiol. 2021 Apr 22.
[4] Han S et al., Evaluation of HASTE T2 weighted image
with reduced echo time for detecting focal liver lesions in
patients at risk of developing hepatocellular carcinoma. Eur J
Radiol. 2022 Nov 1;157:110588.
[5] Mule S et al., Fast T2-weighted liver MRI: Image
quality and solid focal lesions conspicuity using a deep
learning accelerated single breath-hold HASTE fat-
suppressed sequence. Diagn Interv Imaging. 2022
Oct;103(10):479-485.
[6] Ginocchio LA et al., Accelerated T2-weighted MRI of
the liver at 3 T using a single-shot technique with deep


learning-based image reconstruction: impact on the image
quality and lesion detection. Abdom Radiol (NY). 2022 Sep 28.
[7] Herrmann J et al., Comprehensive clinical evaluation
of a deep learning-accelerated, single-breath-hold abdominal
HASTE at 1.5 T and 3 T. Acad Radiol. 2022 Apr 22:S1076-
6332(22)00195-7.
[8] Ichinohe F. et al., Usefulness of Breath-Hold Fat-
Suppressed T2-Weighted Images With Deep Learning–Based
Reconstruction of the Liver, Invest Radiol., 2022

[1] Guenthner C. et al. Ristretto MRE: A generalized multi-
shot GRE-MRE sequence. NMR Biomed 2019; 32:e4049.

[1] Walsh DO, Gmitro AF, Marcellin MW. Adaptive
reconstruction of phased array MR imagery. Magn Reson
Med. 2000 May 1;43(5):682–90.
[2] Kordbacheh H, Seethamraju RT, Weiland E, Kiefer B, Nickel
MD, Chulroek T, et al. Image quality and diagnostic accuracy
of complex-averaged high b value images in diffusion-
weighted MRI of prostate cancer. Abdom Radiol (NY).
2019;44(6):2244–53


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

Medical devices - Application of risk
management to medical devices

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

Medical device software - Software life
cycle processes

62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION

NEMA MS 6-2008 (R2014)
Determination of Signal-to-Noise Ratio
and Image Uniformity for Single-
Channel Non-Volume Coils in
Diagnostic MR Imaging

Digital Imaging and Communications in
Medicine (DICOM) Set

Biological evaluation of medical devices
- part 1: evaluation and testing within a
risk management process.
(Biocompatibility)


1101 West 34th St #550, Austin, TX 78705, US

Company Representative
Meritxell Martinez

Yujan Shrestha, MD
Ethan Ulrich
Andrew Smith, MD, PhD
Steven Rothenberg, MD
Jim Luker, RN, MS

Date Summary Prepared
January 30th, 2024

Documentation Prepared Using
Innolitics Medtech OS Framework


Automated Radiological Image Processing Software


EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System


EFAI Intelligent
Cardiothoracic Ratio
(iCTR) Assessment
System (K212624)

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS


Medical image processing
and management system

CT Cardiomegaly is
software intended to be run
on its own or as part of
another medical device to
automatically calculate
linear and area based
cardiothoracic ratio (CTR)
from a CT image
containing the heart.
CT Cardiomegaly is
designed to measure the
maximal transverse
diameter of heart and
maximal inner transverse
diameter of thoracic cavity
and calculate the CTR from
an axial CT slice
containing the heart using a
non-adaptive machine
learning algorithm.
Intended users of the
software are aimed to the
physicians or other
licensed practitioners in the
healthcare institutions,
such as clinics, hospitals,
healthcare facilities,
residential care facilities
and long-term care
services.
The system is suitable for
adults and transitional
adolescents (18 to 21 years
old but treated as an adult).
Its results are not intended
to be used on a stand-alone
basis for clinical-decision

EFAI Intelligent
Cardiothoracic Ratio
Assessment System (or
iCTR) is a software for use
by hospital and clinics to
automatically assess the
cardiothoracic ratio (CTR)
of a chest X-ray image from
the X-ray imager subject.
The iCTR is designed to
measure the maximal
transverse diameter of heart
and maximal inner
transverse diameter of
thoracic cavity and calculate
the CTR of a chest X-ray
image in posterior-anterior
(PA) chest view using an
artificial intelligence
algorithm.
Intended users of the
software are aimed to the
physicians or other licensed
practitioners in the
healthcare institutions, such
as clinics, hospitals,
healthcare facilities,
residential care facilities and
long-term care services.
The system is suitable for
adults between 20 - 80 years
of age.
Its results are not intended
to be used on a stand-alone
basis for clinical-decision
making or otherwise
preclude clinical assessment

Both the subject (CT Cardiomegaly)
and predicate device (iCTR) have
identical indications for use, with the
exception that the subject device
analyzes CT images while the predicate
device is limited to X-ray images.
Another difference between the
indications for use for both devices is
that the predicate uses artificial
intelligence algorithms using an
unknown framework while the subject
device utilizes non-adaptive machine
learning algorithms using the MONAI
framework.
However, these differences in
technological characteristics do not
affect safety and effectiveness of the
device, and have been supported with
verification and validation testing.


making or otherwise
preclude clinical
assessment of any disease.

Post-anterior (PA) view
chest X-ray image

The input for the predicate device is a
2-dimensional chest X-ray image, while
the subject device’s input is an entire
CT study. The subject device will select
out of the CT study an axial slice
containing the heart, if present, and
perform measurements. The main
difference is that the predicate operates
on images that are post-anterior (PA)
view chest X-ray, while the subject
device’s operates on images that are
axial CT. Nonetheless, this difference
in imaging modality does not raise any
new concerns and has been verified and
validated in testing.

The output format of the predicate
device includes reports and DICOM
secondary capture series, while the
subject device’s only output format is a
report (in both PDF and JSON format).
Thus, the subject device’s output
format is a subset of the predicate’s
available output formats (i.e., report).
This lack of a feature does not raise any
new concerns.

The predicate device outputs a linear-
based CTR measurement while the
subject device outputs both linear and
area-based CTR measurements.
Although this output measurement of
area-based CTR is not included in the
predicate device, it does not raise
different questions of safety or
effectiveness and has been properly
verified and validated in testing.

Report will be output in
the PDF and JSON
file format which is
structured with following

Report will be output in
the DICOM and JSON
file format which is
structured with following

Both devices produce reports that
output CTR and patient information.
One of the main differences between
both devices is that the predicate only


information:
1) CTR (both linear and
area-based)
2) Patient information
3) Reference value(s)

information and function
tool:
1) CTR
2) adjustable annotation line
(maximal inner border
diameter of thoracic cavity
and maximal diameter of
heart)
3) the trajectory of CTR
(including chest X-ray)
4) Patient information

has one CTR output, while the subject
device outputs both linear-based CTR
and area-based CTR. This difference is
further discussed in the row above.
Additionally, the predicate device
presents the feature to modify the
annotation line, which is not available
in the subject device. However, CT
Cardiomegaly ’s indications for use
explicitly state that the results produced
by the device are not intended to be
solely relied upon for clinical decision-
making, nor do they replace the need
for clinical assessment of any disease.
Furthermore, the user manual of the
device contains instructions mandating
healthcare professionals to review the
results presented in the report.
Both devices produce reports that
contain relevant patient information.
The predicate device includes a
trajectory of the CTR in the report. The
subject device includes segmentations
of the heart area and inner chest area.
Lastly, the subject device introduces a
feature to have user-specified reference
value(s) stated in the report. The
healthcare professional is able to set
reference value(s) linear and area-based
CTR, based on published literature or
their practice of medicine. This feature
is not found in the predicate device, but
has been properly verified and
validated.

Physicians or other
licensed practitioners in
the healthcare
institutions

Adults and transitional
adolescents (18 to 21 years
old but treated as an adult)"

Both devices have similar intended
target populations. The subject device’s
patient population age range has been
supported by appropriate performance
testing.


EFAI Intelligent
Cardiothoracic Ratio
(iCTR) Assessment
System (K212624)

Although the predicate and subject
device are compatible with different
imaging modalities, this technological
difference does not raise new questions
of safety or effectiveness. Additionally,
this difference has been properly
supported with verification and
validation testing.

Healthcare institutions
(Clinics, hospitals,
healthcare facilities,
residential care facilities
and long-term care
services)

Software device
that
operates on off-the-
shelf
hardware

Software devices
uses
software
algorithms for
image

Same, with the main difference that
diameter measurements are performed
on an axial slice of the CT series for the
subject device (not on chest x-ray, as
done for the predicate).

Saved in JSON and
DICOM file format text
for DICOM and
DICOM file format

Both devices store study reports in
machine-readable JSON format.
The predicate device also stores files in
DICOM format. On the other hand, the
subject device also outputs reports in
PDF format. This difference in file
format does not raise any new questions
of safety or effectiveness, and is


Ubuntu 20.04.5 LTS
(provided as a Docker
container)
Docker 23.0.1 or above

Ubuntu 18.04
(Web browser :
chrome 88.0.4324.182
or above)

Both devices have similar software
requirements. The subject device
requires a newer version of the
operating system that runs inside a
container. The main difference is that
the predicate device is intended to run
on a web browser while the subject
device is a command line software
intended to be run on its own or as part
of another medical device. This
technological difference does not raise
any new questions of safety or
effectiveness, and is supported by
verification and validation testing.

Machine learning based
algorithm (non-adaptive)

Same. Machine learning based
algorithm is a subset of artificial
intelligence.


Anatomical Structure
Observed Dice [95% CI]


Measurement [units]
Description
Workflow
Application

In general, myocardial strain is a measure of the deformation in
shape and dimension of the heart muscle during the cardiac
cycle. Mathematically Circle uses the Lagrangian strain tensor
and measures the deformation with respect to the reference (end
diastole) phase. The radial, circumferential and longitudinal
strains are defined as the strain tensor evaluated in the radial,
circumferential and longitudinal directions on the appropriate SAX
or LAX slices (in 2D), respectively.

• SAX-Circumferential
• SAX-Radial
• LAX-Longitudinal
• LAX-Radial

• This measurement for the global
myocardium, or specific regions of
myocardium, can be represented over
time by Strain Curves.
• Strain is also presented as an Image
Overlay.

The maximum of the strain in absolute value, over the whole
cardiac cycle.

• This measurement, on a regional basis,
can be visualized and reported in Polar
Maps.
Note: Global peak circumferential strain
and global peak longitudinal strain can
be added by the user to the clinical
report.

Trigger time elapsed from the first phase till the phase where the
peak strain has been reached.

Derivative of the strain with respect to time.

The maximum of the strain rate in absolute value over all phases
starting from the end systole till the next diastole.

The maximum of the strain rate in absolute value over all phases
starting from the end diastole till the next systole.

The displacement vector represents the position of a point with
respect to the position of that point in the reference (end diastole)
phase. The radial (both SAX and LAX) and longitudinal (LAX)

• Strain Curves, as above.
Displacement is also presented as an
Image Overlay.

Table 1. Measurements in the Strain Module.


displacements are expressed in mm and the circumferential
(SAX) displacement is presented in degree.

The maximum of the displacement in absolute value, over the
whole cardiac cycle (expressed in mm for radial and longitudinal,
and in degree for circumferential displacements).

Trigger time elapsed from the first phase till the phase where the
peak displacement has been reached.

Derivative of the displacement with respect to time (expressed in
mm/s or degree/s, as appropriate). The circumferential velocity
represents an angular velocity.

Peak Systolic Velocity [mm/s or
degree/s]

The maximum of the velocity in absolute value over all phases
starting from the end diastole till the next systole (expressed in
mm/s or degree/s, as appropriate).

• SAX-Circumferential
• SAX-Radial
• LAX-Longitudinal
• LAX-Radial

Peak Diastolic Velocity [mm/s or
degree/s]

The maximum of the velocity in absolute value over all phases
starting from the end systole till the next end diastole (expressed
in mm/s or degree/s, as appropriate).

The difference in rotation between the apical and basal slices
divided by the distance between apical and basal slices. Note that
circumferential displacement represents an angle.

The difference in rotational velocity between apical and basal
slices divided by the distance between the apical and basal
slices. Note that circumferential velocity represents an angular
velocity.


Manufactured by Circle
Manufactured by TomTec

The Myocardial Strain Software Application is intended
for qualitative and quantitative evaluation of
cardiovascular MR images in a DICOM Standard
format. As prerequisite, the user confirms endocardial
and epicardial contours in a reference phase, and the
software tracks features over the cardiac cycle and
computes 2D myocardial deformation and movement
(e.g., strain, displacement, velocity).

2D CPA MR software is intended for quantification of
the myocardial deformation (strain) and movement
(displacement / velocity) for digital magnetic
resonance images. Possible quantification results are
velocity, displacement, strain, strain rate, time-to-peak
and phase.
Prerequisite is to draw a contour (endocard or
endocard and epicard) in a digital magnetic resonance
image. Based on this manual drawn contour, the SW
calculates with a tracking algorithm the borders’
displacement.

The Myocardial Strain Software Application is intended
for qualitative and quantitative evaluation of
cardiovascular magnetic resonance (CMR) images. It
provides measurements of 2D LV myocardial function
(displacement, velocity, strain, strain rate, time to
peak, and torsion); these measurements are used by
qualified medical professionals, experienced in
examining and evaluating CMR images, for the
purpose of obtaining diagnostic information for
patients with suspected heart disease as part of a
comprehensive diagnostic decision-making process.

2D Cardiac Performance Analysis is intended for
cardiac quantification based on magnetic resonance
images. It provides measurements of myocardial
function (displacement, velocity, strain, strain rate) that
is used for diagnostic purposes of patients with
suspected heart disease.

Table 2. Intended use and indications comparison.


Medical image management and
processing system

Picture Archiving and Communications
System

Regulation Number
21 CFR 892.2050
21 CFR 892.2050

Endocardial and epicardial contours in
reference phase(s).

Contours (endocardial, or endocardial and
epicardial) in a digital magnetic resonance
image

Myocardial deformation
assessment technique

Comprehensive functional
assessment of myocardial function

2D functional analysis of
myocardial deformation

Express parameters in their
spatial directions (e.g.,
circumferential, longitudinal radial)

Overlay of tracked contour and
graphical displays for measured
parameters

Myocardial Function Global and
Regional Measurements

• Displacement
• Velocity
• Strain
• Strain Rate
• Time to Peak
• Torsion

Table 3. Regulatory and technological features comparison.


NemoScan software allows for
surgical guide export to a validated
manufacturing center or to the point
of care.
Manufacturing at the point of care
requires a validated process using
CAM equipment (additive
manufacturing system, including
software and associated tooling) and
compatible material (biocompatible
and sterilizable).
A surgical guide may require to be
used with accessories.

Classification
21 CFR 892.2050, Class II
21 CFR 892.2050, Class II
21 CFR 892.2050, Class II

Adolescents (12-21 years of age) to
adults (>21 years of age)

For edentulous, partial edentulous or
dentition situations

Input Source
CT / CBCT scanner
CT / CBCT, DVT scanners
CT / CBCT scanner

Export
.stl file format
.stl file format
.stl file format


Make reports of the implant
treatment plan.

Anatomical site
Oral-maxillofacial regions
Oral-maxillofacial regions
Oral-maxillofacial regions

PC with specified requirements on
hardware, operating system and
security (in user manual)

The scanned surface data acquired
by the optical/intraoral scanner can
be aligned to the CT/CBCT
reconstruction through a point-based
registration technique

CAD tools to manipulate/modify/
render/import/export/sectioning
patient models (teeth, upper/lower
jaws), surgical item models, areas of
interest. Includes:
- Panoramic curve
- Nerve detection
- Virtual structures
- Orient images to occlusal plane-
Surgical item libraries
- Bone density analyses, geometric
measurements


2D gray value images
3D model rendering
Panoramic mode
MPR mode
Individual editing of imaging artifacts
3D Photo in .Obj format
Align 3D with Photos
Image treatment

2D gray value images
3D model rendering.
Panoramic mode
MPR mode
3D Photo in .Obj format
Align 3D with Photos

Virtual Wax-up
Possible
Possible
Possible

Nerve tracing
Possible
Possible
Possible

Teeth segmentation and coordinate
system;
DICOM to STL conversion;
Mesh transformation;
Sinus segmentation;
Reorient the 3D volume;
Root and teeth segmentation;
Teeth extractions;
Panoramic curve;

Teeth segmentation and coordinate
system;
DICOM to STL conversion;
Sinus segmentation;
Reorient the 3D volume;
Root and teeth segmentation;
Teeth extractions;
Panoramic curve;

Teeth segmentation and
coordinate system;
DICOM to STL conversion;
Mesh transformation;
Sinus segmentation;
Reorient the 3D volume;
Roots segmentation and complete
teeth fusion;
Teeth extractions;
Panoramic curve;

Implant, sleeve, drill, abutment,
analog, and pin positioning;
Custom Implant, Sleeve, Drill,
Abutment, and Pin creation;
Implant-to-implant, Implant-to-nerve
canal, Sleeve-to-Sleeve, and
Sleeve-to- STL surface
distance/collision warning;
Prosthesis wizards;

Implant, sleeve, drill, abutment, analog,
and pin positioning;
Custom Implant, Sleeve, Drill, Abutment,
and Pin creation;
Implant-to-implant, Implant-to-nerve
canal, Sleeve-to-Sleeve surface
distance/collision warning;

Implant, sleeve, drill, abutment,
and pin positioning;
Custom Implant, Sleeve, Drill,
Abutment, and Pin creation;
Implant-to-implant,
Implant-to-nerve canal,
Sleeve-to-Sleeve, and Sleeve-to-
STL surface distance/collision
warning


Prosthesis wizards;
Implant validations;

Design the surgery guide based on
the implant treatment plan, such as:
● Tooth-supported surgical
guide design possible;
● Gingiva-supported surgical
guide design possible;
● Bone-supported surgical
guide design possible;
● Export of surgical guide
design data set possible;
● Gingivectomy guide;
● Offset, thickness and
connector setting possible;
● Add label text in surgical
guide;

Design the surgery guide based on the
implant treatment plan, such as:
● Tooth-supported surgical guide
design possible;
● Gingiva-supported surgical guide
design possible;
● Bone-supported surgical guide
design possible;
● Gingivectomy guide;
● Export of surgical guide design
data set possible;
● Offset, wall thickness and
connector thickness setting
possible.
● Add label text in surgical guide;

Design the surgery guide based
on the implant treatment plan,
such as:
● Tooth-supported surgical
guide design possible;
● Gingiva-supported surgical
guide design possible;
● Bone-supported surgical
guide design possible;
● Offset, wall thickness and
connector thickness setting
possible;
● Export of surgical guide
design data set possible;

Surgical
protocol design
and creation tool

Details protocol: available per
implant providing detailed implant,
sleeve and surgical protocol
information together with images of
the planning views;
Surgical protocol: The sequence of
surgical instruments to be used as
specified by the selected guided
surgery system (selected
manufacturers only)

Analog model, Virtual pour up and
model builder.

OS - Windows 10 64-bit;
16 GB RAM Memory minimum

OS - Windows 7, 64-bit;
8GB RAM Memory minimum

Windows 7/8/8.1/10
4 GB RAM Memory minimum


(CPU) - Intel Core i7 at 2.8GHz
Network cards wired, minimum
speed 1 Gb./sec;
NVidia graphics card. Minimum 2
GB. VRAM
HDD – 15 GB of free space

(CPU) - Intel® Core™ 2 Duo processor
P8600
Graphics Card and Network cards- Not
specified
HDD – 128 GB of free space

16 GB RAM Memory
recommended
Intel Core i7 at 2.8GHz
5 GB free disc space or more
Internet connection requirement


Regulation Number
Regulation Name
Product Code

Ultrasonic Pulsed Doppler Imaging System

21 CFR § 892.1560
Ultrasound Pulsed Echo Imaging System
IYO

21 CFR § 892.1570
Diagnostic Ultrasonic Transducer
ITX

Regulation Number, Name and Product Codes:


Device Trade Name:
Clarius Ultrasound Scanner

Submitter Name:
Clarius Mobile Health Corp.


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

Clarius Charger HD3
Clarius Power Fan HD3

The Clarius Ultrasound Scanner, subject of this 510(k) premarket notification, comprises the following:


Criteria
SUBJECT DEVICE
PREDICATE DEVICE

Clarius Ultrasound Scanner
Clarius Ultrasound Scanner

510(k) Holder/
Clarius Mobile Health Corp.
Clarius Mobile Health Corp.

Product Codes
IYN1, IYO2, ITX3
IYN1, IYO2, ITX3

Ultrasonic Pulsed Doppler Imaging System1;
Ultrasonic Pulsed Echo Imaging System2;
Diagnostic Ultrasonic Transducer3

Phased Array and Linear Array
(the phased array and linear array are
arranged side-by-side within the same
transducer model)

Phased Array, Linear Array
(the phased array and linear array are
represented in two separate transducer
models)

Diagnostic ultrasound imaging or fluid flow
analysis of the human body

The Clarius Ultrasound Scanner is a software-
based ultrasound imaging system and
accessories, intended for diagnostic imaging.
It is indicated for diagnostic ultrasound
imaging and fluid flow analysis in the
following applications: ophthalmic, fetal,
abdominal, intra-operative (non-
neurological), pediatric, small organ, cephalic
(adult), trans-rectal, trans-vaginal, musculo-
skeletal (conventional, superficial), urology,
gynecology, cardiac (adult, pediatric),
peripheral vessel, carotid, and procedural
guidance of needles into the body.
The system is a transportable ultrasound
system intended for use in environments
where healthcare is provided by trained
healthcare professionals.

Comparison of the Subject Device and Predicate Device for Demonstration of Substantial Equivalence


Phased Array (PAL HD3):
• Fetal
• Abdominal
• Intraoperative
• Pediatric
• Cardiac (adult, pediatric)
Linear Array (PAL HD3):
• Ophthalmic
• Abdominal
• Intraoperative
• Pediatric
• Small Organ (thyroid, prostate, scrotum,
breast)
• Musculoskeletal (conventional,
superficial)
• Peripheral vessel
• Carotid
• Needle enhance in B-Mode

Phased Array (PA HD3):
• Fetal
• Abdominal
• Intraoperative (abdominal organs and
vascular)
• Pediatric
• Cephalic (adult)
• Cardiac (adult, pediatric)
Linear Array (L15 HD3):
• Ophthalmic
• Abdominal
• Intraoperative (abdominal organs and
vascular)
• Pediatric
• Small Organ (thyroid, prostate, scrotum,
breast)
• Musculoskeletal (conventional,
superficial)
• Peripheral vessel
• Carotid
• Needle enhance in B-Mode

Piezoelectric material in the system’s
transducer transmits high frequency, non-
ionizing sound waves to the designated
region of the body and converts the
subsequent echoes detected to electronic
signals in order to construct an image of the
internal structures of an anatomical field. The
image is sent wirelessly from the transducer
to an external iOS or Android viewing device
on which the image can be displayed.

Internal integrated built-in (non-removable)
lithium-ion battery

Display
iOS or Android mobile device
iOS or Android mobile device

Communicates wirelessly via Wi-Fi and
Bluetooth

Portability
Portable ultrasound system
Portable ultrasound system

Transducer/scanner
Software (Clarius App)
Accessories (Charger and Power Fan)

Transducers/scanners
Software (Clarius App)
Accessories (Charger and Power Fan)

1-5 MHz (Phased Array) and 5-15 MHz (Linear
Array)

1-5 MHz (Phased Array-PA HD3) and 5-15
MHz (Linear Array-L15 HD3)

B-mode
M-mode
Color Doppler
Power Doppler


Criteria
SUBJECT DEVICE
PREDICATE DEVICE

Clarius Ultrasound Scanner
Clarius Ultrasound Scanner

Pulse-Wave Doppler (PWD)
Combined (B+M; B+CD; B+PD; B+PWD)

The Clarius Ultrasound Scanner complies with
the following safety standards:
60601-1
60601-1-2
60601-1-6
60601-1-12
60601-2-37

Licensed healthcare professionals (e.g.,
doctors, nurses, sonographers) trained in
ultrasound use.

Environment of
Hospital, clinic, ambulatory setting
Hospital, clinic, ambulatory setting


Standard Designation No.
Title of Standard

Medical device software - Software life cycle processes

Medical Devices - Application of risk management to medical devices

Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance

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

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

Medical Electrical Equipment - Part 2-37: Particular Requirements For the basic
safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment

Medical Electrical Equipment - Part 1-12: General requirements for basic safety
and essential performance - Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems intended for use in the
emergency medical services environment

Scanner device family, demonstrates compliance to the following standards:


Secondary cells and batteries containing alkaline or other non-acid electrolytes -
Safety requirements for portable sealed secondary cells, and for batteries made
from them, for use in portable applications

Biological evaluation of medical devices – Part 1: Evaluation and testing within a
risk management process

Medical devices - Symbols to be used with information to be supplied by the
manufacturer – Part 1: General requirements

Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
Revision 3

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

NEMA Standards Publication UD 3-2004 (R2009) Standard for Real-Time Display of
Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound
Equipment

Degrees of protection provided by enclosures (IP Code)

IEC 61157: Standard means for the reporting of the acoustic output of medical
diagnostic ultrasonic equipment


Scintillator material: LYSO
Number of detector rings:
• 96 (uMI Panorama 28)
• 120 (uMI Panorama 35)
Axial FOV:
• 280mm (uMI Panorama 28)
• 350mm (uMI Panorama 35)

Scintillator material: LYSO
Number of detector rings:
• 96 (uMI Panorama 28)
• 120 (uMI Panorama 35)
Axial FOV:
• 280mm (uMI Panorama 28)
350mm (uMI Panorama 35)

CT System
uCT ATLAS Astound (K223028)
uCT ATLAS Astound (K223028)


to separate the image communication platform from the BriefCase-Triage SW. The subject device

consists of only the algorithm analysis module which can be integrated with image communication

platforms that meet the BriefCase-Triage input and output requirements.

incorporated in software packages for use with DICOM compliant CT scanners, PACS, and radiology


Predicate Device
Rapid PE Triage and
Notification (PETN)
(K220499)

Reference Device
BriefCase-Triage for
PE triage
(K222277)

Subject Device
Aidoc BriefCase-
Triage of Central
Pulmonary
Embolism (Central
PE)

Rapid PE Triage and
Notification (PETN) is
a radiological
computer aided triage
and notification
software indicated for
use in the analysis of
CTPA images. The
device is intended to
assist hospital
networks and trained
clinicians in workflow
triage by flagging and
communication of
suspected positive
findings of central
pulmonary embolism
(PE) pathology in
adults. The software is
only intended to be
used on single-energy
exams.
Rapid PETN uses an
artificial intelligence
algorithm to analyze
images and highlight
cases with detected
findings on a server or
standalone desktop
application in parallel
to the ongoing
standard of care image
interpretation. The

BriefCase is a
radiological computer
aided triage and
notification software
indicated for use in the
analysis of CTPA
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 Pulmonary
Embolism (PE)
pathologies.
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.

BriefCase-Triage is a
radiological computer-
aided triage and
notification software
indicated for use in the
analysis of CTPA
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
communicating
suspected positive
cases of Central
Pulmonary Embolism
(Central PE).
BriefCase-Triage uses
an artificial intelligence
algorithm 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 Central
PE findings.
Notifications include


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 Rapid
PETN 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.
Rapid PETN is
validated for use on
GE, Siemens and
Toshiba scanners.

The user is presented
with notification for
cases with suspected
findings. Notifications
include compressed
preview images that
are
meant for informationa
l purposes only and
not intended for
diagnostic use
beyond notification. T
he 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.

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-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.


Hospital networks and
trained clinicians

Hospital networks and
appropriately trained
medical specialists

Notification-only,
parallel workflow tool

Artificial intelligence
algorithm with
database of images.

- The Rapid
PETN module
operates within
the integrated
Rapid Platform
and uses the
basic services
supplied by the
Rapid Platform
including
DICOM
processing, job
management,
imaging
module
execution and
imaging
output.

- AHS module
(image
acquisition);
- ACS module
(image
processing);
- Aidoc Desktop
Application for
workflow
integration
(Feed/Worklist
(alternate
names) and
non-diagnostic
Image
Viewer).

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


Table 4. Frequency Distribution of Gender


Table 5. Frequency Distribution of Manufacturer


Predicate Device
FDA Clearance Number and
Product
Manufacturer

Reference Device
FDA Clearance Number and
Product
Manufacturer

Siemens Shenzhen
Magnetic Resonance Ltd.


Hardware
Subject Devices
Predicate Device
Reference Devices

MAGNETOM Cima.X Fit
MAGNETOM Vida with
MAGNETOM Sola with

with software syngo MR
syngo MR XA50A
syngo MR XA51A

New or modified features as
listed in the Device
Description above

Summary hardware comparison table for the subject and predicate device


Software
Subject Device
Predicate Device

MAGNETOM Cima.X Fit with
MAGNETOM Vida with syngo

SE-based pulse sequence types
New feature as listed in the Device
Yes

GRE-based/Steady-State pulse
New or modified pulse sequences
Yes

EPI-based pulse sequence types
New features as listed in the Device
Yes

Spectroscopy pulse sequence types
Yes
Yes

Other features and
Modified features and
Yes

User interface and user interaction
Yes
Yes

Viewing and post-processing
New or modified viewing and post-
Yes

Workflow and software utilization
Yes
Yes

Scanning
Modified and new features and
Yes


Performance Test
Source/Rationale for test

Guidance for the Content of Premarket
Submissions for Software Contained in
Medical Devices

Guidance for submission of Premarket
Notifications for Magnetic Resonance
Diagnostic Devices

Image quality
assessment by sample
clinical images

- new / modified pulse
sequence types.
- comparison images
between the new / modified
features and the predicate
device features

Performance bench test
new and modified hardware

Electrical, mechanical,
structural, and related
system safety test

Electrical safety and
electromagnetic
compatibility (EMC)

The following performance testing was conducted on the subject devices:


Performance Test
Tested Hardware or Software
Source/Rationale for test

- SNR and image uniformity
measurements for coils
- Heating measurements for coils

Guidance for Submission of
Premarket Notifications for
Magnetic Resonance Diagnostic
Devices

reference devices and can be reused for the subject device:


 TSE: more than 25,000 slices
 HASTE: pre-trained on the
TSE dataset and refined with
more than 10,000 HASTE
slices
 EPI Diffusion: more than
1,000,000 slices
The data covered a broad range
of body parts, contrasts, fat
suppression techniques,
orientations, and field strength.

on more than 10,000 high
resolution 2D images.
The data covered a broad range
of body parts, contrasts, fat
suppression techniques,
orientations, and field strength.

Test Statistics and Test Results
Summary

The impact of the network has
been characterized by several
quality metrics such as peak
signal-to-noise ratio (PSNR) and
structural similarity index (SSIM).
Most importantly, the
performance was evaluated by
visual comparisons to evaluate
e.g., aliasing artifacts, image
sharpness and denoising levels.

The impact of the network has
been characterized by several
quality metrics such as peak
signal-to-noise ratio (PSNR),
structural similarity index (SSIM),
and perceptual loss. In addition,
the feature has been verified
and validated by inhouse tests.
These tests include visual rating
and an evaluation of image
sharpness by intensity profile
comparisons of reconstructions
with and without Deep Resolve
Sharp.

No clinical subgroups have been defined for the collected dataset.

Due to reasons of data privacy, we did not record gender, age and
ethnicity during data collection.

The acquired datasets (as
described above) represent the
ground truth for the training and
validation. Input data was
retrospectively created from the
ground truth by data
manipulation and augmentation.
This process includes further
under-sampling of the data by
discarding k-space lines,
lowering of the SNR level by
addition Restricted of noise and
mirroring of k-space data.

The acquired datasets represent
the ground truth for the training
and validation. Input data was
retrospectively created from the
ground truth by data
manipulation. k-space data has
been cropped such that only the
center part of the data was used
as input. With this method
corresponding low-resolution
data as input and high-resolution
data as output / ground truth
were created for training and
validation.


[14_1] Bae SH et al., Clinical feasibility of accelerated
diffusion weighted imaging of the abdomen with deep
learning reconstruction: Comparison with conventional
diffusion weighted imaging, Eur J Radiol., 154 (2022)
[14_2] Lee EJ et al., Feasibility of deep learning k-
space-to-image reconstruction for diffusion weighted
imaging in patients with breast cancers: Focus on
image quality and reduced scan time, Eur J Radiol., 157
(2022)
[14_3] Afat S et al., Acquisition time reduction of
diffusion-weighted liver imaging using deep learning
image reconstruction. Diagn Interv Imaging, (2022).
[14_4] Benkert T et al., Improved Clinical Diffusion
Weighted Imaging by Combining Deep Learning
Reconstruction, Partial Fourier, and Super Resolution,
ISMRM (2022)

[14_6] Herrmann J et al., Diagnostic Confidence and
Feasibility of a Deep Learning Accelerated HASTE
Sequence of the Abdomen in a Single Breath-Hold,
Investigative Radiology, Volume 56, Number 5, May
2021.
[14_7] Shanbhogue K et al. Accelerated single-shot T2-
weighted fat-suppressed (FS) MRI of the liver with
deep learning-based image reconstruction: qualitative
and quantitative comparison of image quality with
conventional T2-weighted FS sequence. Eur Radiol.
2021 May 7.
[14_8] Herrmann J et al., Development and Evaluation
of Deep Learning-Accelerated Single-Breath-Hold
Abdominal HASTE at 3 T Using Variable Refocusing Flip
Angles. Invest Radiol. 2021 Apr 22.
[14_9] Han S et al., Evaluation of HASTE T2 weighted
image with reduced echo time for detecting focal liver
lesions in patients at risk of developing hepatocellular
carcinoma. Eur J Radiol. 2022 Nov 1;157:110588.
[14_10] Mule S et al., Fast T2-weighted liver MRI:
Image quality and solid focal lesions conspicuity using
a deep learning accelerated single breath-hold HASTE
fat-suppressed sequence. Diagn Interv Imaging. 2022
Oct;103(10):479-485.
[14_11] Ginocchio LA et al., Accelerated T2-weighted
MRI of the liver at 3 T using a single-shot technique
with deep learning-based image reconstruction:
impact on the image quality and lesion detection.
Abdom Radiol (NY). 2022 Sep 28.
[14_12] Herrmann J et al., Comprehensive clinical
evaluation of a deep learning-accelerated, single-

of the following features and functions:


breath-hold abdominal HASTE at 1.5 T and 3 T. Acad
Radiol. 2022 Apr 22:S1076-6332(22)00195-7.
[14_13] Ichinohe F. et al., Usefulness of Breath-Hold
Fat-Suppressed T2-Weighted Images With Deep
Learning–Based Reconstruction of the Liver, Invest
Radiol., 2022

[14_14] Guenthner C. et al. Ristretto MRE: A
generalized multi-shot GRE-MRE sequence. NMR
Biomed 2019; 32:e4049.

[14_24] Hoge WS, Polimeni JR. Dual-polarity GRAPPA
for simultaneous reconstruction and ghost correction of
echo planar imaging data. Magn Reson Med. 2016
Jul;76(1):32-44. doi: 10.1002/mrm.25839. Epub 2015

[14_5] Polimeni JR, Bhat H, Witzel T, Benner T, Feiweier
T, Inati SJ, Renvall V, Heberlein K, Wald LL. Reducing
sensitivity losses due to respiration and motion in
accelerated echo planar imaging by reordering the
autocalibration data acquisition. Magn Reson Med.
2016 Feb;75(2):665-79. doi: 10.1002/mrm.25628. Epub
2015 Mar 23. PMID: 25809559; PMCID: PMC4580494.

[14_25] D. Polak, D N. Splitthoff, etc. Scout accelerated
motion estimation and reduction (SAMER). Magn
Reson Med. 2022 Jan;87(1):163-178.
[14_26] M. Lang, A. Tabari, etc. Clinical Evaluation of
Scout Accelerated Motion Estimation and Reduction
Technique for 3D MR Imaging in the Inpatient and
Emergency Department Settings. American Journal of
Neuroradiology 2023 Jan.

[14_22] Walsh DO, Gmitro AF, Marcellin MW. Adaptive
reconstruction
of phased array MR imagery. Magn Reson Med. 2000
May
1;43(5):682–90.
[14_23] Kordbacheh H, Seethamraju RT, Weiland E,
Kiefer B, Nickel MD, Chulroek T, et al. Image quality and
diagnostic accuracy of complex-averaged high b value
images in diffusion-weighted MRI of prostate cancer.
Abdom Radiol (NY). 2019;44(6):2244–53.


Monsuru K Bello
Regulatory Affairs
monsuru.bello@siemens-healthineers.com
+1(202) 856-6099

Clayton Ginn
Regulatory Affairs
clayton.ginn@siemens-healthineers.com
+1 (865) 898-2692

Siemens Medical Solutions, Inc. USA
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932
Establishment Registration Number: 1034973

Siemens Healthcare GmbH
Siemensstr 1
D-91301 Forchheim, Germany
Establishment Registration Number: 3004977335

Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Establishment Registration Number: 2240869


syngo.via RT Image Suite
syngo.via RT Image Suite

(software version: SOMARIS/8 VB80)
(software version SOMARIS/8 VB70)

syngo.via RT Image Suite is a 3D and 4D image visualization,
multi-modality manipulation and contouring tool that helps
the preparation of treatments such as, but not limited to
those performed with radiation (for example,
Brachytherapy, Particle Therapy, External Beam Radiation
Therapy).
It provides tools to view existing contours, create, edit,
modify, copy contours of regions of the body, such as but
not limited to, skin outline, targets and organs-at-risk. It also
provides functionalities to create simple geometric
treatment plans. Contours, images and treatment plans can
subsequently be exported to a Treatment Planning System.
The software combines the following digital image
processing and visualization tools:
• Multi-modality viewing and contouring of anatomical,
functional, and multi-parametric images such as but not
limited to CT, PET, PET/CT, MRI, Linac CBCT images
• Multiplanar reconstruction (MPR) thin/thick, minimum
intensity projection (MIP), volume rendering technique
(VRT)
• Freehand and semi-automatic contouring of regions-of-
interest on any orientation including oblique
• Automated Contouring on CT images
• Creation of contours on images supported by the
application without prior assignment of a planning CT
• Manual and semi-automatic registration using rigid and
deformable registration
• Supports the user in comparing, contouring, and
adapting contours based on datasets acquired with
different imaging modalities and at different time points
• Supports multi-modality image fusion
• Visualization and contouring of moving tumors and
organs
• Management of points of interest including but not
limited to the isocenter
• Creation of simple geometric treatment plans
• Generation of a synthetic CT based on multiple pre-
define MR acquisitions

6. Indications for Use Comparison to the Predicate Device


Europe: 58, US: 165, Canada: 39, South America: 78, Australia: 28, Asia: 33,
unknown: 12

Head&Neck: 113, Thorax&Abdomen: 216, Pelvis: 84

Gender
Male: 188, female: 174. Unknown: 51

Siemens: 126, GE: 77, Philips: 140, unknown/others: 70

Table 1: Distribution of validation data across subgroups


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

Digital Imaging and Communications in
Medicine (DICOM) Set

Application of Risk Management to Medical
Devices

Edition 1.1
2020-06
CONSOLIDATED
VERSION

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

Medical devices - Symbols to be used with
information to be supplied by the
manufacturer - Part 1: General requirements

First edition
2021-04
Corrected
version 2021-
12

Medical devices - Information to be supplied
by the manufacturer


Classification Name(s)
Regulation Number
Product Code

Ultrasonic Pulsed Doppler Imaging System

Ultrasonic Pulsed Echo Imaging System
21 CFR 892.1560
IYO

Diagnostic Ultrasound Transducer
21 CFR 892.1570
ITX

Medical Image Management and Processing
System


Device Trade Name:
Butterfly iQ/iQ+ Ultrasound System

Primary Product Code:
IYN – 21 CFR 892.1550


Medical Electrical Equipment – Part 1. General
requirements for basic safety and essential performance

Medical electrical equipment - Part 1-11: General requirements
for basic safety and essential performance - Collateral Standard:
Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
CONSOLIDATED EDITION

Medical electrical equipment - Part 1-12: General requirements
for basic safety and essential performance - Collateral Standard:
Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical
services environment CONSOLIDATED EDITION

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

methods for evaluating the safe and effective performance of the device:


Medical Electrical Equipment – Part 2-37. Particular
requirements for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring equipment
CONSOLIDATED EDITION

Biological evaluation of medical devices — Part 1: Evaluation
and testing within a risk management process

Biological evaluation of medical devices — Part 5: Tests for in
vitro cytotoxicity

Biological evaluation of medical devices — Part 10: Tests for
irritation and skin sensitization

Application of risk management to medical devices


of the subject hardware and its compatibility with the cleared Butterfly iQ App and to

its safe and effective performance. Verification and validation testing established that the

meets its design requirements, intended use, and demonstrates substantial equivalence

Relevant non-clinical verification and validation testing was performed to address the


Butterfly iQ3
Ultrasound
System (Subject
Device)

Butterfly iQ/iQ+
Ultrasound System
(K220068,
Predicate Device)

subject device and the predicate device.


Intended for use by
qualified and trained
healthcare professionals
to enable diagnostic
ultrasound imaging and
measurement of
anatomical structures and
fluids of adult and
pediatric patients.

Hand-held portable
diagnostic ultrasound
system.


Peripheral Vessel
(including carotid, deep
vein thrombosis, arterial
studies)


Multi-slice
collects and
displays B-
mode images
from different
angles
separately. This
new mode does
not change the
acoustic output
to the normal
B-Mode or 3-D
image, nor
does it
introduce any
new questions
of safety and
effectiveness.

Sweep collects
and
continuously
displays B-
mode images
from different
angles. This
new mode does
not change the
acoustic output
to the normal
B-Mode or 3-D
image, nor
does it
introduce any
new questions
of safety and
effectiveness.


Similar. The
subject device
remains within the
boundaries of the
predicate device
and does not
introduce any new
questions of safety
and effectiveness.

Professional
healthcare facilities
(e.g. Hospital,
clinic, hospice, or
medical office),
home healthcare


home healthcare
environment,
ambulances
and/or accident
sites, and other
environments
where healthcare
is provided. Users
may also include
medical students
working under the
supervision or
authority of a
physician during
their education/
training.

Meets electrical
safety standards
for a class II
medical device.
Group 1
Class B (CISPR)

Will meet
mechanical safety
standards for a
class II medical
device


mechanical safety mechanical safety Unchanged


Appx. Probe
dimensions (L x W x
D), inches


Aquilion ONE (TSX-
306A/3) V10.12 with
Spectral Imaging
System

JAK:
System, X-ray,
Tomography,
Computed


Device Name,
Aquilion ONE (TSX-308A/3) V1.4
Aquilion ONE (TSX-306A/3) V10.12

Model Number
with PIQE Reconstruction System
with Spectral Imaging System

PIQE Reconstruction
System
▪ Scan Regions
▪ Scan Type
▪ Intensity
▪ Reconstruction
image matrix
▪ Image thickness
▪ Reconstruction
Interval

Available
▪ Cardiac, Abdomen and pelvis (Body)
▪ Volume scan, Dynamic volume scan,
Helical scan
▪ L1 / L2 / L3
▪ 512 x 512, 1024 x 1024
▪ 0.5 and 1.0 mm, 2.0 mm (Helical only)
▪ 0.25 (With option installed), 0.5, 1.0,
2.0 mm (Helical only)

Available
▪ Cardiac
▪ Volume scan, Dynamic volume scan
▪ MILD / STANDARD / STRONG
▪ 512 x 512
▪ 0.5 and 1.0 mm
▪ 0.25 (With option installed) and 0.5
mm

▪ Adaptive Iterative Dose Reduction 3D
(AIDR 3D)
▪ AIDR 3D Enhanced
▪ Advanced Intelligent Clear‐IQ Engine
(AiCE)

Conventional scan (Axial Scan)
Volume, Dynamic volume, Dynamic scan
Helical scan

Conventional scan (S&S, S&V)
Volume, Dynamic volume scan
Helical scan

Single, Dual,
S-Helical (3D Landmark Scan)

Scan (Rotation) time
(Some may require
additional options)

Three (3) types:
Small, Large, SilverBeam Filter (Dose
reduction wedge)

Three (3) types:
Medium, Large, SilverBeam Filter (Dose
reduction wedge)

Operating panel
Two operating panels on the front

Image display matrix
2428 x 1230 (max.)
1024 x 1024 (max.)

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


Axial3D Insight
Axial Medical Printing Limited
K222745


Attribute
Axial3D Insight
Axial3D Insight
Comparison

(Proposed Device)
(Predicate Device K222745)

Device Name
Axial3D Insight
Axial3D Insight

Automated Radiological Image
Processing Software

Automated Radiological image
Processing Software

Axial3DInsight is intended for use
as a cloud-based service and
image segmentation framework
for the transfer of DICOM imaging
information from a medical
scanner to an output file.

Table 5-2 – Predicate Device Comparison: Intended Use


The Axial3DInsight output file can
be used for the fabrication of
physical replicas of the output file
using additive manufacturing
methods.
The output file or physical replica
can be used for treatment
planning.
The output file or physical replica
can be used for diagnostic
purposes in the field of orthopedic
trauma, orthopedic, maxillofacial,
and cardiovascular applications.
Axial3DInsight should be used
with other diagnostic tools and
expert clinical judgment.

Axial Medical Printing Limited’s,
Axial3D Insight provides patient
specific 1:1 scale replica models,
either as a digital file or as a 3D
printed physical model.
The digital file or 3D printed
physical model is intended to be
used in conjunction with the
DICOM images and expert
clinical judgement. The
applications for using the physical
3D printed physical model as a
presurgical planning tool are as
follows:
Preoperative planning of surgical
treatment options including
planning for surgical instruments,
aiding decisions on implants, and
aiding the surgical treatment
plan., All planning using the 3D
replica model should be carried
out with the assistance of the
DICOM images
Communication with the surgical
team to discuss the surgical
treatment plan in conjunction with
DICOM images.
Communication with the patient
to discuss the surgical treatment


plan in conjunction with DICOM
images
Education tool for surgical
planning. The 3D printed physical
model can be used for surgical
planning in the following
applications: orthopedics and
trauma, maxillofacial, and
cardiovascular surgery.

plan in conjunction with DICOM
images.
Education tool for surgical
planning. The 3D printed physical
model can be used for surgical
planning in the following
applications: orthopedics and
trauma, maxillofacial, and
cardiovascular surgery.

Used in conjunction with other
diagnostic tools and expert
clinical judgement.

Environment Hospital Hospital Equivalent


Orthopedics / Trauma
Cardiovascular
Cranio- Maxillofacial

Region/volume
of interest
measurements
and size
measurements

Formlabs
• Form 3B
Stratasys
• J750
• J5 Medijet
• J850
• Origin One
HP
• HP580
• HP540

Formlabs
• Form 3B
Stratasys
• J750
• J5 Medijet
HP
• HP580
• HP540

Formlabs
• Form 3B
o Standard White V4
FLGPWH04
o Standard Draft V2
FLDRGR02
o Standard Clear V4
FLGPCL04
o Flexible 80A V1
FLFL8001
Stratasys
• J750
o Agilus,
o VeroBlackPlus,
o VeroClear,


Attribute
Axial3D Insight
Axial3D Insight
Comparison

(Proposed Device)
(Predicate Device K222745)

o VeroCyan,
o VeroGrey,
o VeroMagenta,
o VeroPureWhite,
o VeroYellow
• J5 Medijet
o VeroVividTMCyan,
o VeroVividTMMagenta,
o VeroVividTMYellow,
o DraftWhite,
o MED610,
o MED615RGD,
o VeroUltraClearTM
o ElasticoTMClear
• J850
o VeroVividTMCyan,
o VeroVividTMMagenta,
o VeroVividTMYellow,
o VeroPureWhite
o BoneMatrixTM
o GelMatrixTM
o TissueMatrixTM
o RadioMatrixTM
o Agilus30
o VeroClear
o VeroMagenta
o BlackPlus
• Origin One
o ORIGIN DM100 by
BASF
o ORIGIN DM200 by
BASF
o LOCTITE 3D 3843
o LOCTITE 3D IND405
HP
• HP580
o Nylon PA12
• HP540

o VeroCyan,
o VeroGrey,
o VeroMagenta,
o VeroPureWhite,
o VeroYellow
• J5 Medijet
o VeroVividTMCyan,
o VeroVividTMMagenta,
o VeroVividTMYellow,
o DraftWhite,
o MED610,
o MED615RGD,
o VeroUltraClearTM
o ElasticoTMClear
HP
• HP580
o Nylon PA12
• HP540
o Nylon PA12


Lightspeed Pro 16
Lightspeed Pro 32
Revolution CT
Optima CT660
Discovery CT750 HD

SOMATOM Definition Flash
SOMATOM Definition Edge
SOMATOM Definition AS
SOMATOM Definition AS+

Table 5-4 – Imaging scanner manufactures and models used for the validation datasets


SOMATOM Perspective
SOMATOM Force
Sensation 16
AXIOM-Artis
Emotion 16

IQON Spectral CT
iCT 128
iCT 256
Ingenuity Core 128
Brilliance 62


Specification
Subject Device
Predicate Device
Comparison
Impact to Safety &

Manufacturer
Siemens Healthcare GmbH
Siemens Healthcare GmbH
Same

Syngo Carbon Clinicals is intended to provide
advanced visualization tools to prepare and
process the medical image for evaluation,
manipulation and communication of clinical
data that was acquired by the medical imaging
modalities (for example, CT, MR, etc.)
The software package is designed to support
technicians and physicians in qualitative and
quantitative measurements and in the analysis
of clinical data that was acquired by medical
imaging modalities.
An interface shall enable the connection
between the Syngo Carbon Clinicals software
package and the interconnected software
solution for viewing, manipulation,
communication, and storage of medical
images.

Syngo Carbon Space is a software intended to
display medical data and to support the review
and analysis of medical images by trained
medical professionals.
Syngo Carbon Space "Diagnostic Workspace"
is indicated for display, rendering, post-
processing of medical data (mostly medical
images) within healthcare institutions, for
example, in the field of Radiology, Nuclear
Medicine and Cardiology.

The indications for use of
Syngo Carbon Clinicals is a
subset of the predicate.
Subject device is used in
qualitative and quantitative
measurements and in the
analysis of clinical data
which is the same as the
predicate device.
Note: For our equivalency
comparison, the Syngo
Carbon Space "Diagnostic
Workspace" shall be
considered since the
functionalities of Syngo
Carbon Space "Physician
Access" is not relevant to our
subject device scope.
The Predicate device
additionally also is used for
display and rendering of
medical data.


Syngo Carbon Clinicals is not indicated for
mammography images for diagnosis in the
U.S.
Syngo Carbon Clinicals is not to be used as a
sole basis for clinical decisions

Syngo Carbon Space "Diagnostic Workspace"
is not intended for diagnosis of digital
mammography images.
Syngo Carbon Space "Diagnostic Workspace"
is not intended to be used as a sole basis for
clinical decisions.

Syngo Carbon Clinicals has architecture that
is based on a layered pattern where the
various clinical tools/functionality are
decomposed into modules/common tools
which provide their individual functionalities.

Syngo Carbon Space is based on a
client-server architecture

A client server architecture is
not used in the subject device
due to the nature of the use
of the subject device with the
interfacing/hosting
applications.

Syngo Carbon Clinicals relies on the
interfacing application for Image
communication.

Standard network protocols like
TCP/IP and standard communication
protocol including DICOM (2016a)
and non-DICOM objects. Supports
interfacing with HL7 (v2.5 / v2.3.1 /v2.3 /
FHIR R4).

Syngo Carbon Clinicals does
not have its own
communication, it relies on
the interfacing/hosting
application for Image
communication.


• MPR: MPR, MPR Thick,
• MPR/MPR*
• MIP: MIP, MIP Thin
• MinIP View
• VRT*: Plain VRT, Adapt VRT,
• VRT Thin, Cinematic VRT (cVRT)
• Fused View *
• Invert Image
* available in in Diagnostic
Workspace only

Syngo Carbon Clinicals
provides the rendering tool:
Cinematic Insight which is
a combination of the
Automatic Organ
segmentation and the cVRT
technique of image display
which is available in the
predicate device.
This feature uses a deep
learning algorithm for organ
segmentation (algorithm that
was cleared as part of the
reference device syngo.via
RT Image suite (K220783).
No changes have been made
to this algorithm compared
to the reference device
The segmented organ is then
rendered using the cVRT
technique available in the
predicate device.

This feature does not
impact the safety and
effectiveness of the
subject device as the
necessary measures are
taken


Measurement,
Evaluation/Interpr
etation
Tools

• Oncological evaluation:
o Lesion Quantification
o Assisted Perpendicular Tool
o Lung Nodule Marker
• Orthopaedic measurements:
o Manual calibration

• Lesion Quantification*
• Assisted Perpendicular Tool*
• Automatic Organ Segmentation*
• Distance (Distance line, Distance Polyline)
• Angle
• 2D ROI (Circle, Freehand, Polygonal, Auto
Contour) *
• 3D VOI (Sphere, Freehand) *
• Pixel Lens
• Ranges (Parallel, Radial, Radial Sliced,
Curved, Spine) *
• Interactive Tissue Segmentation*
• Time Curve, Time ROI*
• SUV Measurement*
• Automatic Anatomy Labeling (rib, spine) *
• Next Study/ Previous Study*
* available in in Diagnostic Workspace only

Lung Nodule Marker tool is
used to evaluate the lung for
suspected lesions across time
points.
Manual calibration tool is a
simple linear tool, where the
user input of measurement is
required for calibration of the
image using a known size
display image/an object of
known size is available in the
image


Specification
Subject Device
Predicate Device
Comparison
Impact to Safety &

INDEO2, INDEO3, INDEO4,
MPEG1, MPEG2, MPEG4, VP8,
VP9, WMV1, WMV2, WMV3
Text Documents: CDA (XML),
PDF


Client – Mobile device
iPadOS ≥ 14, Safari web browser

None
Syngo Carbon Clinicals provides advanced
visualization tools to prepare and process the
medical images and it has no influence on the
image acquisition devices

None
Syngo Carbon Space is a pure viewing
and/or post-processing software and it
has no influence on the image
acquisition devices

None
No automated diagnostic
interpretation capabilities like CAD
are included. All image data are to be
interpreted by trained personnel.

Clinical
condition the
device is
intended to
diagnose, treat,
or manage

No limitation on the clinical condition
of the patient

No limitation concerning the patient
population (e.g., age, weight, health,
condition)

Site of the body
the device is
intended to be
used

No limitation concerning region of
body or tissue type


Syngo Carbon Clinicals offers a wide range
of tools from the major clinical fields, i.e.
general radiology, oncology environments.

Syngo Carbon Space “Diagnostic
Workspace” is used in Radiology,
Nuclear Medicine and Cardiology
environments (e.g., darkened/ shaded
rooms).

Device Type
Software application
Software application
Same

The cybersecurity aspects for Syngo Carbon
Clinicals is handled by the interfacing/hosting
system.

User access control
• Audit Trail
• Documentation of system security
information, Network traffic &
Firewall control
• Support of virus / malware
protection
• System Hardening (OS level and
Network level)

Syngo Carbon Clinicals
applications are running as a
part of the interfacing device.
The aspects for cybersecurity
are assessed and provided to
the interfacing application.

Hardware is not understood as part of
the medical device but needs to
comply with the minimum
requirements as specified by Syngo
Carbon Clinicals

Hardware is not understood as part of
the medical device but needs to
comply with the minimum
requirements as specified by Syngo
Carbon Space


Specification
Subject Device
Predicate Device
Comparison
Impact to Safety &

Yes, with reduced color palette,
clearer structure, and text labels on
icons. Floating panels increases the
user friendliness as the user can move
the panels wherever they are
convenient with.

The subject device utilizes
the GUI provided by the
interfacing application


Search, browse & open data for
display from syngo.share core &
remote DICOM nodes
• Search, browse & open data for
display from external XDS(-I)
repository) **
• Archive functionality (upload
medical data to syngo.share core
for archive)
• Document properties functions
(metadata modification and
tagging)
• Correct & re-arrange functions
• Restore (trigger fetch from
archive) functions
• Distribution, export & sharing
functions
• Inbox - access to medical data
shared by other users **
**available in Physician Access only


Yes, with a fast overview of the
displayed and not displayed data
(series, images) of the loaded studies,
identify not yet seen series/images*,
quickly identify the relevant
series/images for reading, and bring
data (timepoints/series/images) into
display in an efficient manner
(Drag&Drop).
Study / Timepoints are marked with
individual colors for better
identification.
The Series Navigator is called
Document Preview for Physician
Access.
* available in in Diagnostic
Workspace only

Findings panel collects measurements,
annotations, and graphical objects.
Additionally, the user can create new
findings, edit findings. It also allows
creation of automatic findings.

The subject device utilizes
the findings panel provided
by the interfacing application


No dedicated report creation
functionality supported in Syngo
Carbon Space.
Structured findings can be
automatically transferred to external
third-party reporting system via FHIR
interface for creation of structured
report content [e.g. (Powerscribe [by
Nuance], SmartReports [by Smart
Reporting)]

The subject device utilizes
the Reporting functionality
provided by the interfacing
application

Diagnostic Workspace:
Syngo Carbon Space Diagnostic
Workspace does not store data or
images.
Created results for a study (e.g.
DICOM PR, SR objects) are stored in
syngo.share core in context of the
original study. syngo.share core is
responsible for long term archiving of
the original study and created results.
Physician Access:
Not applicable since Syngo Carbon
Space Physician Access does not
create data or images that is
transferred/stored.

The subject device utilizes
the archival functionality
provided by the interfacing
application


• Arrow*
• Marker*
• Text
* available in in Diagnostic
Workspace only

The subject device utilizes
the annotation functionality
provided by the interfacing
application

Diagnostic workspace:
Structured findings can be printed on a
paper printer.
Phyisican Access:
Provides printing functionality on a
paper printer

The subject device utilizes
the Printing functionality
provided by the interfacing
application

Yes, with search, indexing, filtering,
library function and document
collections.


Subject Device
Predicate Device
Reference Device

raise different questions of the safety and effectiveness.


adult patients are
considered to be valid
input.

Algorithm
Deep Learning
Deep Learning
Machine-learning

Segmentation of
Organ at Risk in
the Anatomic
Regions

CT: Head & Neck,
Thorax, Abdomen &
Pelvis
Head & Neck lymph
nodes
(166 OAR)
MR: Pelvis (9 OAR)

CT: Head & Neck,
Thorax, Abdomen &
Pelvis
Head & Neck lymph
nodes
(128 OAR)

Male and female
pelvis, with soft-tissue
cancer in the
anatomical pelvic
region below L1
vertebra, including
(post-operative)
prostate, rectum, anus,
bladder and cervix

No Limitation on
scanner model for CT.
Siemens Healthineers’
data only for MR.
DICOM compliance
required.

No Limitation on
scanner model,
DICOM compliance
required.

Ingenia 1.5T and 3.0T
MR-RT, Ingenia
Ambition 1.5T MR-RT
and Ingenia Elition
3.0T MR-RT

No Limitation on TPS
model, DICOM
compliance required.

Contraindications
Adult use only
Adult use only
Adult use only

AI-Rad Companion
Organs RT is designed
for use only in adult
populations.
AI-Rad Companion
Organs RT is designed
for any patient for
whom relevant
modality scans are
available. More
specifically, the
software is validated
on previously acquired
CT DICOM volumes
for radiation therapy
treatment planning,
including, head and


Clinical
condition the
device is
intended to
diagnose, treat or
manage

Limited to patients
previously selected for
Radiation Therapy.

AI-Rad Companion
(Engine) architecture
enabling the
deployment of AI Rad
Companion Organs RT
using Edge and in the
Cloud. The UI is
provided using a web-
based interface.

Creating, editing and
deletion of organ
templates. Customize
predefined structure
database with mapping
to international
nomenclature schemes.

AI-Rad Companion
Organs RT
automatically
processes input image
data and sends the
results as DICOM-RT
Structure Sets to a
user-configurable
target node.

Contour
visualization and
editing feature

AI-Rad Companion
Organs RT provides
basic result preview of
automatic
segmentation results,
and no editing feature
of the automatic
segmented contour.


MR: The target
performance was
validated using 66
cases to validate the
overall performance of
the MR contouring.
CT: The target
performance was
validated using 414
cases distributed to
three cohorts.
Both: To objectively
evaluate the target
performance, the DICE
coefficient, the
absolute symmetric
surface distance
(ASSD) and the fail
rate was evaluated.
The segmentation
performance of the
subject was equivalent
to the overall
performance compared
to the predicate,
reference device and
comparable literature
& devices.

The target performance
was validated using
157 cases distributed to
two cohorts. Cohort A
is clinical routine
treatment planning CT
and it is split into two
sub-cohort and Cohort
B is PET-CT data. To
objectively evaluate
the target performance,
the DICE coefficient,
the absolute symmetric
surface distance
(ASSD) and the fail
rate was evaluated.
The segmentation
performance of the
subject and reference
device were equivalent
as well as the overall
performance compared
to the predicate device.

The mean and standard
deviation Dice
coefficients, along with
the lower 95th
percentile confidence
bound were calculated.

User Interface –
Results Preview
(Confirmation)

Basic visualization
functionality of
original data and
generated contours

Results send to
Confirmation UI &
Optional bypassing of
Confirmation UI to
TPS

Design to be used by
trained clinicians.

Designed to be used by
trained clinicians


Medical Devices –
Application of usability
engineering to medical
devices

Medical Devices –
application of risk
management to medical
devices

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

Digital Imaging and
Communications in
Medicine (DICOM) Set

Medical devices – symbols
to be used with information
to be supplied by the
manufacturer – Part 1:
General Requirements

Health software – Part 1:
General requirements for
product safety

following voluntary FDA recognized Consensus Standards listed in Table 2.


Validation Testing Subject
Acceptance Criteria

• The average segmentation accuracy (Dice
value) of all subject device organs should
be equivalent or better than the overall
segmentation accuracy of the predicate
device
• The overall fail rate for each
organ/anatomical structure is smaller than
15%


Table 3: Acceptance Criteria of AIRC Organs RT VA50


AI-Rad Companion Organs RT VA50 – all organs

AI-Rad Companion Organs RT VA50 – common
organs

Table 4: Performance results of subject device


Study AVG STD MED 95%CI AVG STD MED 95%CI

Table 5: Performance results of subject device compared to the reference device


Age
22 years and older
22 years and older

Manufacturer
Siemens Healthineers
Siemens Healthineers

Body
Femoral Head Right
Femoral Head Left

Anal Canal, Prostate, Rectum, Penile
Bulb, Seminal Vesicle, Bladder


Age
22 years and older
22 years and older
62 (average)

Manufacturer
Siemens Healthineers
Siemens Healthineers
Siemens Healthineers

Anal Canal, Rectum,
Penile Bulb, Seminal
Vesicle, Bladder

Table 7: Validation Testing Data Information


• All the organs segmented in the predicate
device are also segmented in the subject
device
• The average (AVG) Dice score difference
between the subject and predicate device
is smaller than 3%

• Baseline value defined by subtracting the
reference value using 5% error margin in
case of Dice and 0.1 mm in case of ASSD
• The subject device in the selected reference
metric has a higher value than the defined
baseline value.


able 4: Perform
a
nce su
mmary o
f the sub
ject dev
ice CT c
ontouring


<30 : 0
30 – 50: 0
50 – 70: 4
>= 70: 4
Unknown: 110
*unknown due to data
minimization on
customer site

Siemens: 53
GE: 59
Philips: 119
Varian: 44
Others: 26

Head & Neck: 24
Thorax & Abdomen: 20
Pelvis: 29

Head & Neck: 50
Thorax: 81
Abdomen: 115
Pelvis: 55

Table 5: Detailed Performance evaluation of the new organs in the subject device


LN Supraclavicular, Axilla Levels,
Internal Mammaries


Pulmonary Artery, Vena Cava,
Trachea, Spinal Canal, Proximal
Bronchus


EthosTreatmentManagementisusedto
manageandmonitorradiationtherapy
treatmentplansandsessions;itisintendedto
beusedwithatreatmentplanningsystem.
(Sameaspredicate)

EthosTreatmentManagementisindicatedfor
useinmanagingandmonitoringtreatment
plansandsessions.
(Sameaspredicate)

EthosTreatmentPlanningisindicatedforusein
generatingandmodifyingradiationtherapy
treatmentplans.
(Sameaspredicate)


Primary-AI-Rad CAI-
Rad Companion Organs
RT (K221305) Siemens

Reference-Contour
ProtégéAI(K223774)
MIM Software

Medical Image Management
And Processing System

Table 1. Substantial Equivalence Comparison


Algorithm
Deep Learning
Deep Learning
Machine-learning

Segmentation of
Organ at Risk in
the Anatomic
Regions

Head & Neck, Thorax,
Abdomen & Pelvis
(82 OARs)

H e a d & N e ck, Thorax,
Abdomen & Pelvis
Head & Neck lymph
nodes
(108 OAR)

Head & Neck,Prostate,
Thorax, Abdomen, Lungs
& Liver, MRT structures
(spleen, pelvic lymph
nodes, descending
aorta, bone)

No Limitation on scanner
model,
DICOM compliance required.

No Limitation on TPS model,
DICOM
compliance required.

Contraindications
Adult use only
Adult use only
Adult use only

DeepContour is designed for
use only in adult populations
for whom relevant modality
scans , including head and
neck, thorax, abdomen, and
pelvis, are available .

AI-Rad Companion Organs
RT is designed for use only
in adult populations. AI-Rad
Companion Organs RT is
designed for any patient for
whom relevant modality
scans are available. More
specifically, the software is
validated on previously
acquired CT DICOM
volumes for radiation
therapy treatment planning,
including, head and neck,
thorax, abdomen, and pelvis.


Server-based application
supporting
Windows and Local
deployment on Windows.

AI-Rad Companion
(Engine) architecture
enabling the deployment of
AI Rad Companion Organs
RT using Edge and in the
Cloud. The UI is provided
using a webbased interface.

Server-based application
supporting
Linux-based OS and Local
deployment on Windows
or Mac

Creating, editing and deletion
of organ templates. Customize
predefined structure database
with mapping to international
nomenclature schemes.

DeepContour automatically
processes input image data and
sends the results as DICOM-
RT Structure Sets to a user-
configurable target node.

AI-Rad Companion Organs
RT automatically processes
input image data and sends
the results as DICOM-RT
Structure Sets to a user-
configurable target node.

Automatic contouring
working using machine-
learning

Contour
visualization and
editing feature

DeepContour provides basic
result preview of automatic
segmentation results, and
editing feature of the
automatic segmented contour.

AI-Rad Companion Organs
RT provides basic result
preview of automatic
segmentation results, and no
editing feature of the
automatic segmented
contour.


User Interface –
Results Preview
(Confirmation)

Basic visualization
functionality of original data
and generated contours

Results send to Confirmation
UI & Optional bypassing of
Confirmation UI to TPS

Design to be used by
trained clinicians.


<50: 289
50-70: 415
>70:70
Unknown:26 (unknown due to data minimization on customer site)

Head and neck region: 200
chest region: 200
abdomen region: 200
pelvic region: 200

Philips: 301
GE: 226
Simens: 128
Unknown:145 (unknown due to data minimization on customer
site)


The 2017 lung CT segmentation
challenge (LCTSC): 60
Pancreas-CT (PCT): 43

Unknow:103 (unknown due to data
minimization on customer site)


Unknown:103 (unknown due to data
minimization on customer site)

Head and neck region: 25
chest region: 25
abdomen region: 25
pelvic region: 25

60 thoracic CT scan: 5 segmented
organs (left lung, right lung, heart, spinal
cord, and esophagus)
43 abdominal CT scan: 7 segmented
organs (the spleen, left kidney, esophagus,
liver, stomach, pancreas, and duodenum)

Unknown 103 (unknown due to data
minimization on customer site)


Table 5: Clinical performance comparison (Peking Union Medical College Hospital)


Structure:
DeepContour
AI-Rad CAI-Rad
Contour

Table 6: Clinical performance comparison (LCTSC American public datasets)


Table 8: Rigid and deformable registration


BoneMRI is an image
processing software that can
be used for image
enhancement in MRI images.
It can be used to visualize the
bone structures in MRI
images with enhanced
contrast with respect to the
surrounding soft tissue. It is
to be used in the pelvic
region, which includes the
bony anatomy of the sacrum,
hip bones and femoral heads;
and the lumbar spine region,
which includes the bony
anatomy of the vertebrae
from L3 to S1. BoneMRI is
not to be used for diagnosis
or monitoring of (primary or
metastatic) tumors.
Warning: BoneMRI images
are not intended to replace
CT images.

BoneMRI is an image
processing software that can
be used for image
enhancement in MRI images.
It can be used to visualize the
bone structures in MRI
images with increased
contrast with respect to the
surrounding soft tissue. It is
to be used in the pelvic
region, which includes the
bony anatomy of the sacrum,
hip bones and femoral heads;
and the spine, which includes
the bony anatomy of the
cervical, thoracic, lumbar, and
S1 vertebrae. BoneMRI is
indicated for use in patients
12 years and older.
BoneMRI is not to be used
for diagnosis or monitoring of
(primary or metastatic)
tumors. BoneMRI images are
not intended to replace CT
images in general but can be
used to visualize 3D bone
morphology, tissue
radiodensity and tissue
radiodensity contrast.