• DICOM Images
• DICOM RT Struct
• DICOM RT Plan
• DICOM Key Object
Selection Document
• DICOM RT Dose
• DICOM Raw (Brainlab
Load/Save)
• DICOM Segmentation
• DICOM Registrations
• PDF Report
• ASCII Dose Export

• DICOM Images
• DICOM RT Struct
• DICOM RT Plan
• DICOM Key Object Selection
Document
• DICOM RT Dose
• DICOM Raw (Brainlab
Load/Save)
• DICOM Segmentations
• DICOM Registrations
• PDF Report
• ASCII Dose Export
• csv files

• Multileaf Collimators
• Circular Conical
Collimators

• HTML5
• WPF (only Physics
Administration)


Predicate Device
(RT Elements 4.0 - K223279)

• CT
• MRI
• PET
Furthermore, it is possible to load the
output of the Contrast Clearance
Element which is labeled as OT (other)
Image set.
Background: The Contrast Clearance
Analysis calculation compares two 3D
MRI data sets with injected contrast
agents that were taken 60 to 105
minutes apart (early and late scans).
When comparing the two 3D MRI data
sets, Contrast Clearance Analysis
performs a voxel-by-voxel subtraction
of the early MR images from the late
MR images resulting in a high-
resolution color-coded Treatment
Response Assessment Map (TRAM).
This map provides effective separation
between regions of contrast
accumulation (positive value in red),
and regions of contrast clearance
(negative values in blue). Red regions
show contrast accumulation , i.e. non-
tumor regions and predominantly vessel
necrosis. Dark blue regions show
efficient contrast clearance, i.e.
predominantly morphologically active
tumor regions.

• Pencil Beam Algorithm
• Monte Carlo Algorithm
• Circular Cone Algorithm

• Pencil Beam (PB) Algorithm
• Monte Carlo (MC) Algorithm
• Circular Cone Algorithm


Pencil Beam/Monte Carlo:
better than 3%
Circular Cone:
1%/1mm

In the planning applications it is
possible to add and remove
review objects to/from a
treatment plan.
In general object property
changes are not possible during
treatment planning.

Review objects can be added/removed
in all planning applications as well as
Dose Planning.
PTV (Planning Target Volume) , OAR
(Organ At Risk) and other objects’
properties can be changed for
treatment plans (e.g., name, color and
comment). The optimization result
remains valid after the change.

Separation of
optimization and final
dose calculation

The final dose calculation was
automatically performed at the
end of the optimization.

The user can trigger the final dose
calculation separately from the plan
optimization (VMAT (Volumetric
Modulated Arc Therapy)):
→ Possible to optimize a plan using
PB or MC first and then trigger
final dose calculation using fine
MC parameters
→ MC coarse and MC fine dose is
cached of the current state and
the MC dose of the last
optimization result to enable the
user to easily revert to the last
plan state
→ The fine and coarse MC
parameters visualized in the
dropdown can be defined in the
Clinical Protocol. The spatial
resolution and grid size used
during a MC based optimization
can only be changed in the
Clinical Protocol


Interface to Art-Plan
(by TheraPanacea) for
extracranial workflows

For the following extracranial workflows
an interface to the cloud based 3rd party
contouring system “Art-Plan” by
TheraPanacea (TPC) was introduced.
Art-Plan provides an auto-segmentation
of extracranial structures which are
loaded into Object Management.
Therefore, Art-Plan Connect (part of
Art-Plan) is installed on the same HW as
the RT Elements and works as a
communication gateway between the
main Art Plan cloud service and the RT
Elements.

Component of the RT Elements with a
gRPC API, which serves as an
algorithmic backend for medical image
data processing. The API can readily be
used by client applications to have
access to functionalities for automatic
processing of 2D and 3D medical image
data (e.g. segmentations, landmarks).
To provide its functionality the APM
service also includes interfaces to other
components of the Universal Patient
Model device like
UniversalAtlasPerformer and
UATransferPerformer. Additional
functionality is also implemented
directly in the APM service (like cranial
tumor segmentations).
The component is used by RT
Contouring.


Predicate Device
FDA Clearance Number and
Product
Manufacturer

MAGNETOM Avanto Fit (1.5T)
with syngo MR XA50A

MAGNETOM Skyra Fit (3T)
with syngo MR XA50A


MAGNETOM Sola Fit2 (1.5T)
with syngo MR XA51A

MAGNETOM Viato.Mobile
(1.5T) with syngo MR XA51A

Reference Device
FDA Clearance Number and
Product
Manufacturer


Subject Devices
Predicate Devices
Reference Devices

MAGNETOM Avanto Fit,
MAGNETOM Avanto Fit
MAGNETOM Cima.X

MAGNETOM Skyra Fit,
with syngo MR XA50A
(K231587) with syngo MR

MAGNETOM Sola Fit, and
(K220151), MAGNETOM
XA61A; MAGNETOM Sola

MAGNETOM Viato.Mobile, all
Skyra Fit with syngo MR
(K232535) with syngo MR

Hardware
with software syngo MR
XA50A (K220589),
XA61A; MAGNETOM Vida

XA70A
MAGNETOM Sola Fit with
(K213693) with syngo MR

Summary hardware comparison table for the subject and predicate device


MAGNETOM Avanto Fit,
MAGNETOM Avanto Fit with

MAGNETOM Skyra Fit, MAGNETOM
syngo MR XA50A (K220151),

Sola Fit, and MAGNETOM
MAGNETOM Skyra Fit with

Software
Viato.Mobile, all with software
syngo MR XA50A (K220589),

New features as listed in the Device
Yes

Spectroscopy pulse sequence types
Yes
Yes

User interface and user interaction
Yes
Yes

Viewing and post-processing
processing features as listed in the

Workflow and software utilization
Yes
Yes

Scanning
Cover letter, Device Description

Summary software comparison table for the subject and predicate 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.


[13_1] Christian Guenthner, Sweta Sethi, Marian
Troelstra, Ristretto MRE: A generalized multi‐shot GRE‐
MRE sequence NMR Biomed 2019 32:e4049

[13_2] Henningsson M, Koken P, Stehning C et al.:
Whole-heart coronary MR angiography with 2D self-
navigated image reconstruction Magn Reson
Med, 2012, 67:437–45
[13_3] Prieto C, Doneva M, Usman M et al.: Highly
efficient respiratory motion compensated free-
breathing coronary MRA using golden-step Cartesian
acquisition, J Magn Reson Imaging, 2015 41:738–46
[13_4] Correia T, Ginami G, Cruz G, et al.: Optimized
respiratory-resolved motion compensated 3D Cartesian
coronary MR angiography, Magn Reson Med, 2018
80:2618–2629
[13_5] Chefd’hotel C, Hermosillo G, Faugeras O Flows
of diffeomorphisms for multimodal image registration.
Proc. IEEE International Symposium on Biomedical
Imaging 2002 753–756
[13_6] Batchelor PG, Atkinson D, Irarrazaval P, et al.:
Matrix Description of General Motion Correction
Applied to Multishot Images, Magn Reson Med 2005
54:1273–1280
[13_7] Zeilinger MG, Kunze K-P, Munoz C et al.: Non-
rigid motion-corrected free-breathing 3D myocardial
Dixon LGE imaging in a clinical setting, Eur Radiol 2022
32:4340-4351

SPACE Improvement: high bandwidth
IR pulse

[13_8] Wang X, Greer JS, Dimitrov IE, Pezeshk P,
Chhabra A, Madhuranthakam AJ: Frequency Offset
Corrected Inversion Pulse for B0 and B1 Insensitive Fat
Suppression at 3T: Application to MR Neurography of
Brachial Plexus, J Magn Reson Imaging, 2018 Oct
48(4):1104-1111. doi: 10.1002/jmri.26021. Epub 2018
Sep 15. PMID: 30218576

SPACE Improvement: increase
gradient spoiling

[13_9] Mugler JP 3rd: Optimized three-dimensional fast-
spin-echo MRI, J Magn Reson Imaging, 2014 Apr
39(4):745-67. doi: 10.1002/jmri.24542. Epub 2014 Jan
8. PMID: 24399498.

[13_10] Kellman P. et al Image Reconstruction in SNR
Units: A General Method for SNR Measurement MRM,
2005 54:1439
[13_11] Blu T. et al: The SURE-LET approach to image
denoising, IEEE Transactions on Image Processing, 2007
6(11):2778-86

[13_12] Ilıca AT, Hıdır Y, Bulakbaşı N, Satar B, Güvenç I,
Arslan HH, Imre N. HASTE diffusionweighted MRI for the
reliable detection of cholesteatoma. Diagn Interv

of the following features and functions:


[13_13] J. a. Y. S. S. a. S. M. Wetzl, "AI‐based Single‐Click
Cardiac MRI Exam: Initial Clinical Experience and
Evaluation in 44 Patients," in ISMRM & ISMRT Annual
Meeting & Exhibition, 2023.
[13_14] S. S. a. P. E. a. S. M. a. F. C. a. C. T. a. S. P. a. F. J.
L. a. T. C. a. W. J. a. M. A. Yoon, "Automated Cardiac
Resting Phase Detection Targeted on the Right
Coronary Artery," Machine Learning for Biomedical
Imaging, vol. 2, pp. 1‐26, 2023.
[13_15] S. S. a. S. M. a. R. M. a. C. T. a. S. P. a. E. T. a. T.
C. a. W. R. Yoon, "Validation of a deep learning based
automated myocardial inversion time selection for late
gadolinium enhancement imaging in a prospective
study," in ISMRM & ISMRT Annual Meeting &
Exhibition, 2021.
[13_16] R. a. K. T. a. S. Y. a. Y. Y. a. S. Y. S. a. W. J. a. S.
M. a. K. T. Ogawa, "Neural network‐‐based fully
automated cardiac resting phase detection algorithm
compared with manual detection in patients," Acta
Radiologica Open, vol. 11, no. 10, p.
20584601221137772, 2022.
[13_17] S. a. W. J. a. S. M. a. B. M. a. Y. S. S. a. G. C. a. B.
R. McDermott, "AIbased Cardiac Scan Automation: A
Prospective Comparison of Highly Automated Scan
Workflows in 32 Patients," in Society for Cardiovascular
Magnetic Resonance, 2024.
[13_18] S. a. A. M. a. J. A. a. S. R. B. a. Z. T. a. K. M. a. S.
J. a. T. E. a. C. E. a. S. C. Bohnen, "Cardiovascular
magnetic resonance imaging in the prospective,
population‐based, Hamburg City Health cohort study:
objectives and design," Journal of Cardiovascular
Magnetic Resonance, vol. 20, pp. 1‐11, 2018.
[13_19] T. a. G. P. a. H. T. a. U. T. a. C. S. a. K. M. a. T. S.
a. L. Y. a. M. M. C. a. S. F. Pezel, "Vasodilatation stress
cardiovascular magnetic resonance imaging: Feasibility,
workflow and safety in a large prospective registry of
more than 35,000 patients," Archives of Cardiovascular
Diseases, vol. 114, pp. 490‐503, 2021.
[13_20] G. a. P. A. U. a. K. K. P. a. N. R. a. H. R. a. W. J. a.
Y. S. S. a. S. M. a. N. B. L. a. P. C. a. o. Wood, "Automated
detection of cardiac rest period for trigger delay
calculation for image‐based navigator coronary
magnetic resonance angiography," Journal of
Cardiovascular

[13_21] W Scott Hoge, Jonathan R Polimeni: Dual-
polarity GRAPPA for simultaneous reconstruction and


Picture Archiving and Communications System


Predicate Device
Manufacturer
FDA 510(k)

PIUR tUS Infinity
PIUR Imaging GmbH
K240036


Description
Subject Device
Predicate Device (K240036)

Product Name
PIUR tUS inside
PIUR tUS Infinity

Manufacturer
PIUR Imaging GmbH
PIUR Imaging GmbH

Product Code /
QIH / 21CFR 892.2050
QIH / 21CFR 892.2050

PIUR tUS inside is a computer-aided
detection device intended to assist and
support the medical professionals in the
diagnostic workflow of thyroid and
thyroid nodules acquired from FDA-
cleared ultrasound systems, including
image documentation, analysis, and
reporting. The device supports the
physician with additional information
during image review, including
quantification and visualization of
sonographic characteristics of thyroid
nodules.
PIUR tUS inside may be used on any
adult patient aged 22 and older,
independent of gender, age, linguistic
and cultural background, or health
status, unless any of the
contraindications apply.
PIUR tUS inside device is not intended
for body contact (including skin,
mucosal membrane, breached or
compromised surfaces, blood path
indirect, tissues, bones, dentin, or
circulation blood).

PIUR tUS Infinity is a computer-
aided detection device intended to
assist and support the medical
professionals in the diagnostic
workflow of thyroid and thyroid
nodules acquired from FDA-cleared
ultrasound systems, including image
documentation, analysis, and
reporting. The device supports the
physician with additional
information during image review,
including quantification and
visualization of sonographic
characteristics of thyroid nodules.
PIUR tUS Infinity may be used on
any adult patient aged 22 and older,
independent of gender, age,
linguistic and cultural background,
or health status, unless any of the
contraindications apply.
PIUR tUS Infinity device is not
intended for body contact (including
skin, mucosal membrane, breached
or compromised surfaces, blood path
indirect, tissues, bones, dentin, or
circulation blood).

Table 4: Substantial Equivalence Comparison Table


Functional
Capability of
Image Processing

The device performs 2D to 3D
reconstruction to generate volumetric
data of a thyroid. User-selected
computer vision and machine learning
algorithm suggested volumes of thyroid
lobe and nodules are visualized to be
confirmed by user. Based on that
segmentation, quantification of nodules
for sonographic characteristics
(hyperechoic foci, echogenicity, texture,
margin, orientation and anechoic areas)
is being performed and visualized.

Direct access to the image stream
through the software interface run
directly on the compatible ultrasound
scanner

Infinity Box transfers digital image
from 3rd Party ultrasound system to
the software through WiFi
connection

Device provides quantification and
visualization of sonographic
characteristics based on 3D volumetric
data. Results provide proposals to be
reviewed and confirmed by physicians.

Manual approach whereby user
classifies 5 ACR TI-RADS parameters

The device can export volumetric data,
annotated screenshots and reports.
Report can contain both sides of the
patient and includes all relevant
diagnostic information.

Type of Film to be
Digital ultrasound videoclip (cineloop)
Same

Based on computer vision, machine
learning, pattern recognition and
quantification method.

The ground truth to be established for
performance studies of the device are
annotated data sets labeled by medical
specialists.

Operating System
Ultrasound System
Standard PC or review station


Description
Subject Device
Predicate Device (K240036)

DICOM format:
Secondary Capture Image Storage -
1.2.840.10008.5.1.4.1.1.7
Multi-frame Grayscale Byte Secondary
Capture Image Storage -
1.2.840.10008.5.1.4.1.1.7.2
Multi-frame True Color Secondary
Capture Image Storage -
1.2.840.10008.5.1.4.1.1.7.4
Refer to: DICOM-Conformance
Statement-PIUR tUS inside System

Results from standalone performance
testing of machine learning algorithm
suggested ROIs of user-selected
nodules

PIUR Sensor
PIUR Bracket
inside Software

Infinity Box
PIUR Sensor
PIUR Bracket
Infinity Software

Acquire medical image data from
DICOM compliant Ultrasound imaging
device

Data / Image
Ultrasound image via DICOM format
Same


Subject Device
Second Opinion®
Panoramic

Primary Predicate
Denti.AI Detect
K230144

Secondary Predicate
Second Opinion®
K210365

Manufacturer
Pearl Inc.
Denti.AI Technology, Inc.
Pearl Inc.

Dental CADe to aid with the
detection of regions of interest in
panoramic
radiograph review by HCP

Dental CADe to aid with the
detection of regions of interest in
dental radiograph review by HCP

Dental CADe to aid in dental
radiograph review by HCP

Second Opinion®
Panoramic is a radiological
automated image
processing software device
intended to identify and
mark regions, in panoramic
radiographs, in relation to
suspected dental findings
which include: Caries,
Periapical radiolucency, and
Impacted third molars.
It is designed to aid dental
health professionals to
review panoramic
radiographs of permanent
teeth in patients 16 years of
age or older as both a
concurrent and second
reader.

Denti.AI Detect is a
Computer-Assisted Detection
(CADe) software device intended to
be used by dental professionals,
comprising dentists and dental
specialists, while reading extraoral
and intraoral 2D dental
radiographs.
The device aims to assist in
detecting and highlighting
uncategorized regions of interest
(ROIs)within the teeth area, which
include caries and periapical
radiolucency, as a second reader.
The device is also intended to aid in
the measurements of mesial and
distal bone levels associated with
each tooth.
The device is aimed to be used with
images from the patients of 22
years age and older without
remaining primary dentition. The
device is not intended to replace a
complete clinician's review or
clinical judgment that considers
other relevant information from the
image or patient history.

Second Opinion® is a computer
aided detection (“CADe”) software
to identify and mark regions in
relation to suspected dental
findings which include Caries,
Discrepancy at the margin of an
existing restoration, Calculus,
Periapical radiolucency, Crown
(metal, including zirconia &
non-metal), Filling (metal &
non-metal), Root canal, Bridge and
Implants.
It is designed to aid dental health
professionals to review bitewing
and periapical radiographs of
permanent teeth in patients 12
years of age or older as a second
reader.

Automated, CADe software that
utilizes machine learning

Detection and display of
anatomy and pathologies in
extraoral radiographs

Detection and display of anatomy
and pathologies in intraoral and
extraoral radiographs

Detection and display of anatomy
and pathologies in intraoral
radiographs


Number of dental features on
abnormal images

Table 6 Summary of Image characteristics


Dental feature size on
abnormal images (percent of
image pixels)


Small
50-70 Kg
0.25-2.8 mGy
Proposed Device

size groups, as detailed in the following table:


Proposed devices –
Primary Predicate devices –
Discussion

Low Dose CT Lung Cancer Screening (LD LCS) Option

The Cleared Arineta’s SpotLight / SpotLight Duo

for the SpotLight / SpotLight Duo System

(K241200) CT X-ray System with Low Dose Lung Cancer

(Whole LCS population indication-
Screening (LD LCS) Option

small, medium, and large patient groups)

(LCS medium and large patient groups indication)

The SpotLight / SpotLight Duo is intended to produce cross-
sectional images of the body by computer reconstruction of
X-ray transmission projection data taken at different angles.
The system has the capability to image cardiovascular and
thoracic anatomies, including the heart, in a single rotation.
The system may acquire data using Axial, Cine and Cardiac
scan techniques from patients of all ages (DLIR is limited for
patient use above the age of 2 years). These images may be
obtained either with or without contrast. This device may
include signal analysis and display equipment, patient and
equipment supports, components and accessories.
This device may include data and image processing to
produce images in a variety of trans-axial and reformatted
planes.
The system is indicated for x-ray Computed Tomography
imaging of cardiovascular and thoracic anatomies that fit in
the scan field-of-view.
The Low Dose CT Lung Cancer Screening Option for
SpotLight / SpotLight Duo is indicated for using low dose CT
for lung cancer screening. The screening must be conducted
with the established program criteria and protocols that have
been approved and published by a governmental body or a
professional medical society. Information from professional
societies related to lung cancer screening can be found but
is not limited to: American College of Radiology® (ACR) –
resources and technical specification; accreditation American
Association of Physicists in Medicine (AAPM) – Lung Cancer
Screening Protocols; radiation management. Please refer to
clinical literature, including the results of the National Lung
Screening Trial (N Engl J Med 2011; 365:395-409) and
subsequent literature, for further information.
The DLIR and ASIR-CV options are not compatible with the
Low Dose Lung Cancer Screening option.
The device output is useful for diagnosis of disease or
abnormality and for planning of therapy procedures.

The SpotLight / SpotLight Duo is intended to produce cross-
sectional images of the body by computer reconstruction of
X-ray transmission projection data taken at different angles.
The system has the capability to image cardiovascular and
thoracic anatomies, including the heart, in a single rotation.
The system may acquire data using Axial, Cine and Cardiac
scan techniques from patients of all ages (DLIR is limited for
patient use above the age of 2 years). These images may be
obtained either with or without contrast. This device may
include signal analysis and display equipment, patient and
equipment supports, components and accessories.
This device may include data and image processing to
produce images in a variety of trans-axial and reformatted
planes.
The system is indicated for x-ray Computed Tomography
imaging of cardiovascular and thoracic anatomies that fit in
the scan field-of-view.
The Low Dose CT Lung Cancer Screening Option for
SpotLight / SpotLight Duo is indicated for using low dose CT
for lung cancer screening. The screening must be conducted
with the established program criteria and protocols (for
medium and large patients) that have been approved and
published by a governmental body or a professional medical
society. Information from professional societies related to
lung cancer screening can be found but is not limited to:
American College of Radiology® (ACR) – resources and
technical specification; accreditation American Association of
Physicists in Medicine (AAPM) – Lung Cancer Screening
Protocols; radiation management. Please refer to clinical
literature, including the results of the National Lung
Screening Trial (N Engl J Med 2011; 365:395-409) and
subsequent literature, for further information.
The DLIR and ASIR-CV options are not compatible with the
Low Dose Lung Cancer Screening option.
The device output is useful for diagnosis of disease or
abnormality and for planning of therapy procedures.

The indications for use are
similar except for minor
differences. The indications
for use for the proposed
SpotLight/SpotLight Duo
devices include the whole
Low Dose Lung Cancer
Screening Option with
additional small patient
protocols per AAPM
guidelines (50-70kg, <2.8
mGy).
The indication for use does
not constitute a new
intended use for the CT.


Fast scintillator array coupled to photodiode array.
33 (WFOV) or 23 (EFOV) configurable high resolution (HR)
modules comprising 192 detector rows X pitch 0.5mm (Z
direction, measured at scanner center).
10 (WFOV) or 20 (EFOV) configurable low resolution (LR).
EFOV includes 10 modules on each wing while WFOV
includes 10 modules on one wing. comprising 48 detector
rows X pitch 2.0mm
Analog to digital conversion per channel on the detection
module.
1D antiscatter collimator.

Fast scintillator array coupled to photodiode array.
33 (WFOV) or 23 (EFOV) configurable high resolution (HR)
modules comprising 192 detector rows X pitch 0.5mm (Z
direction, measured at scanner center).
10 (WFOV)-20 (EFOV) configurable low resolution (LR).
EFOV includes 10 modules on each wing while WFOV
includes 10 modules on one wing. comprising 48 detector
rows X pitch 2.0mm
Analog to digital conversion per channel on the detection
module.
1D antiscatter collimator.

Contactless transmission (capacitive coupling). Rate up to
6.25 GBit/sec

Power and control
Brush contact slipring
Brush contact slipring
Same

Rotation drive
Direct drive DC motor
Direct drive DC motor
Same

2 x MCS 2093 X ray tubes by Varex Imaging Corp.
Single ended grounded rotating anode
Anode angle 13 degrees
1.0 MHU anode heat capacity
Grid controlled focal spot modulation in X direction
Small and large focal spots
Max kVp: 140 kV
Max power: 72 KW

Motorized vertical and horizontal motion.
Optional lateral motion
Cantilever carbon fiber patient cradle.

Motorized vertical and horizontal motion.
Optional lateral motion.
Cantilever carbon fiber patient cradle.


Proposed devices –
Primary Predicate devices –
Discussion

Low Dose CT Lung Cancer Screening (LD LCS) Option

The Cleared Arineta’s SpotLight / SpotLight Duo

for the SpotLight / SpotLight Duo System

(K241200) CT X-ray System with Low Dose Lung Cancer

(Whole LCS population indication-
Screening (LD LCS) Option

small, medium, and large patient groups)

(LCS medium and large patient groups indication)

Image reconstruction
Multicore PC and GPU
Multicore PC and GPU
Same

Modified FDK cone beam algorithm adapted for dual tubes
geometry.
Adaptive filter to reduce directional noise in low level raw
data (MBAF).
Non-local means algorithm MBAF2 (optional).
For WFOV configuration, adapted to reconstruct high
resolution images according to detector configuration, lower
resolution images outside FOV covered by high resolution
detectors.
For extended FOV configuration, adapted to reconstruct high
resolution images up to FOV250mm, lower resolution
images outside FOV250mm.

Metal parts (mostly steel and aluminum)
Lead and tungsten for X-ray shielding
PCB, electronic components and electronic cables
components
Table top made of carbon fiber reinforced resin
Covers made pf molded polymers and reinforced resins
Oil in X-ray tubes cooling systems
Detector scintillators made of CdWO4 and Gadolinium
Oxysulfide (GOS) used in other legally marketed CT
scanners

Metal parts (mostly steel and aluminum)
Lead and tungsten for X-ray shielding
PCB, electronic components and electronic cable
components
Table top made of carbon fiber reinforced resin
Covers made pf molded polymers and reinforced resins
Oil in X-ray tubes cooling systems
Detector scintillators made of CdWO4 and Gadolinium
Oxysulfide (GOS) used in other legally marketed CT
scanners

Wall supply 380 to 480 V 3 phase
Max power demand 115 kVA
Max X ray power (total for two tubes) 72kW


Laser alignment lights: gantry bore external lasers. <0.1mW
per laser beam
Three lead ECG trigger module, powered by medical grade
power supply through the system PDU

Provided with software in three domains:
• Console software
• Image reconstruction software
• Embedded software

Max Rotation speed
250 RPM (0.24 sec per rotation)
250 RPM (0.24 sec per rotation)
Same

0.16 sec (partial), 0.24 sec (full scan) – FOV up to 250mm
0.24 sec (full scan) – HR imaging at FOV above 250mm for
asymmetric detector

Max axial coverage in
140mm (280 slices x 0.5mm pitch)
140mm (280 slices x 0.5mm pitch)
Same

25cm - 250mm at high resolution
WFOV - High resolution images at configurable FOV
between 250mm and 450mm
EFOV – Lower resolution in the FOV between HR coverage
and 450mm

17.5 lp/cm cutoff at center
10.0 lp/cm cutoff at radius above 125mm (outside FOV
250mm) covered by HR detectors
7.0 lp/cm cutoff at radius above 125mm (outside FOV
250mm) covered by LR detectors

Max Patient weight
227 Kg (500 lbs)
227 Kg (500 lbs)
Same


Proposed devices –
Primary Predicate devices –
Discussion

Low Dose CT Lung Cancer Screening (LD LCS) Option

The Cleared Arineta’s SpotLight / SpotLight Duo

for the SpotLight / SpotLight Duo System

(K241200) CT X-ray System with Low Dose Lung Cancer

(Whole LCS population indication-
Screening (LD LCS) Option

small, medium, and large patient groups)

(LCS medium and large patient groups indication)

Operator console table
NG2000 Table slickers
Bar code reader
Uninterruptible Power Supply
Head& hands and knees support


Feature
Predicate device
Subject device
Comment

System, x-ray, fluoroscopic,
image-intensified, Solid State
X-ray imager

Luminos Agile Max is a
device intended to visualize
anatomical structures by
converting an X-ray pattern
into a visible image. The
system has medical
applications ranging from
gastrointestinal examinations
to cranial, skeletal, thoracic
and lung exposures as well as
examinations of the urogenital
tract. The unit may also be
used in emergency
applications, lymphography,
endoscopy, myelography,
venography, arthrography,
interventional radiology,
digital angiography and digital
subtraction angiography
(DSA). The system may be
used on pediatric, adult and
bariatric patients.
Luminos Agile Max is not for
mammography examinations.

LUMINOS Q.namix T and
LUMINOS Q.namix R are
devices intended to visualize
anatomical structures by
converting an X-ray pattern
into a visible image. It is a
multifunctional, general R/F
system, suitable for routine
radiography and fluoroscopy
examinations, including
gastrointestinal- and urogenital
examinations and specialist
areas like arthrography,
angiography and pediatrics.
LUMINOS Q.namix T and
LUMINOS Q.namix R are
not intended to be used for
mammography examinations.

Radiography, Pulsed
fluoroscopy, DSA and series
exposure

Radiography, Pulsed
fluoroscopy and series
exposure

Changed, DSA
function is not
available at
LUMINOS


Combined
Applications to
Reduce Exposure

Changed, same touch
user interface as for
reference device
YSIO X.pree is used

Two touch user interfaces at
left and right side, replacing
most of the hardware buttons

Changed, new version
of the Fluoro detector

New, Same as for
reference device
YSIO X.pree.

Operating system Windows 10
Operating system Windows 10
Same

Slightly different,
based on same
processing
software. Same as for
reference device
YSIO X.pree.

Acquisition and Image
processing parameters selected
via Organ Programs

Acquisition and Image
processing parameters selected
via clinical protocols

Changed, same as for
reference device
YSIO X.pree.


Feature
Predicate device
Subject device
Comment

Patient Table
Table with optional bucky tray
Table with optional bucky tray
Same

Changed, optional flat
tabletop is now
available

Wall stand with fixed detector
and wall stand with bucky tray

Live camera for patient
positioning and collimation

Auto Thorax, Auto Long-
Leg/Full-Spine collimation

Changed, same AI-
based cropping used
as for reference device
YSIO X.pree.

Indicator Light at tube stand
(YSIO X.pree option)


System, x-ray, fluoroscopic,
image-intensified, Solid State
X-ray imager

Luminos dRF Max is a device
intended to visualize
anatomical structures by
converting an X-ray pattern
into a visible image. The
system has medical
applications ranging from
gastrointestinal examinations
to cranial, skeletal, thoracic
and lung exposures as well as
examinations of the urogenital
tract. The unit may also be
used in emergency
applications, lymphography,
endoscopy, myelography,
venography, arthrography,
interventional radiology,
digital angiography and digital
subtraction angiography
(DSA). The system may be
used on pediatric, adult and
bariatric patients.
Luminos dRF Max is not for
mammography examinations.

LUMINOS Q.namix T and
LUMINOS Q.namix R are
devices intended to visualize
anatomical structures by
converting an X-ray pattern
into a visible image. It is a
multifunctional, general R/F
system, suitable for routine
radiography and fluoroscopy
examinations, including
gastrointestinal- and urogenital
examinations and specialist
areas like arthrography,
angiography and pediatrics.
LUMINOS Q.namix T and
LUMINOS Q.namix R are
not intended to be used for
mammography examinations.

Radiography, Pulsed
fluoroscopy, DSA and series
exposure

Radiography, Pulsed
fluoroscopy and series
exposure

Changed, DSA
function is not
available at
LUMINOS


Combined
Applications to
Reduce Exposure

Changed, same touch
user interface as for
reference device
YSIO X.pree is used

Changed, new version
of the Fluoro detector

New, Same as for
reference device
YSIO X.pree.

Operating system Windows 10
Operating system Windows 10
Same

Slightly different,
based on same
processing software.
Same as for reference
device YSIO X.pree.

Acquisition and Image
processing parameters selected
via Organ Programs

Acquisition and Image
processing parameters selected
via clinical protocols

Changed, same as for
reference device
YSIO X.pree.

Patient Table
Table with optional bucky tray
Table with optional bucky tray
Same

Standard tabletop
Standard tabletop and flat
Changed, optional flat


Feature
Predicate device
Subject device
Comment

Wall stand with fixed detector
and wall stand with bucky tray

Live camera for patient
positioning and collimation

Auto Thorax, Auto Long-
Leg/Full-Spine collimation

Changed, Same AI-
based cropping used
as for reference device
YSIO X.pree.

Indicator Light at tube stand
(YSIO X.pree option)


Feature
Reference device
Subject device LUMINOS
Comment

Cropping
AI-based Auto Cropping
AI-based Auto Cropping
Same


Max (Predicate)
Max (Predicate)
Q.namix T
Q.namix R

Fluoroscopy
outside of the
Examination
Room

Fluoroscopy at
the table next to
the patient

Q.namix R) to Predicate Devices (Luminos dRF Max and Luminos Agile Max)


Medical Electrical Equipment - Part 1:
General Requirements for Safety

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

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

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

Medical electrical equipment - Part 2-54: Particular requirements
for the basic safety and essential performance of X-ray equipment
for radiography and radioscopy

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

Medical devices – Application of usability engineering tomedical
devices

Medical devices – application of risk management tomedical
devices

Medical device software - Software life cycle processes

Medical electrical equipment - Radiation dose documentation -
Part 1: Radiation dose structured reports for radiography and
radioscopy

Digital Imaging and Communications in Medicine(DICOM) Set

Biological evaluation of medical devices – Part1: Evaluation and
testing within a risk management process

Table 8. Non-clinical performance testing


Classification Name
Computed tomography x-ray system


Proposed Device:
Predicate Device: Bunkerhill
Predicate Device: iCAC

contrast chest computed
tomography (CT) images
collected during clinical care
and outputs the region of
interest (intended for
informational purposes only)
and quantification of detected
calcium.
The device-generated
quantification can be viewed in
the patient report at the
discretion of the physician, and
the physician also has the
option of viewing the device-
generated calcium region of
interest in a diagnostic image
viewer. The subject device
output in no way replaces the
original patient report or the
original non-gated, non-
contrast CT scan; both are still
available to be viewed and used
at the discretion of the
physician.
The device is intended to
provide information to the
physician to provide assistance
during review of the patient’s
case. Results of the subject
device are not intended to be
used on a stand-alone basis and
are solely intended to aid and
provide information to the
physician. In all cases, further
action taken on a patient should
only come at the
recommendation of the

gated, non- contrast chest
computed tomography (CT)
images collected during
clinical care and outputs the
region of interest (intended
for informational purposes
only) and quantification of
detected calcium.
The output of the subject
device is made available to
the physician on-demand as
part of his or her standard
workflow. The device-
generated quantification can
be viewed in the patient
report at the discretion of the
physician, and the physician
also has the option of
viewing the device-
generated calcium region of
interest in a diagnostic
image viewer.
The subject device output
in no way replaces the
original patient report or
the original non-gated, non-
contrast CT scan; both are
still available to be viewed
and used at the discretion
of the physician.
The device is intended to
provide information to the
physician to provide assistance
during review of the patient’s
case. Results of the subject
device are not intended to be
used on a stand- alone basis and
are solely intended to aid and
provide information to the
physician. In all cases, further
action taken on a patient should

automatically analyzes
non- gated, non-contrast
chest computed
tomography (CT) images
collected during routine
care and outputs a visual
representation of
estimated coronary artery
calcium segmentation
(intended for
informational purposes
only) and both exact and
four-category
quantitative estimates of
the patient’s coronary
artery calcium burden in
Agatston units.
The output of the subject
device is made available
to the physician on-
demand as part of his or
her standard workflow.
The device generated
calcium score or score
group can be viewed in
the patient report at the
discretion of the
physician, and the
physician also has the
option of viewing the
device- generated calcium
segmentation in a
diagnostic image viewer.
The subject device output
in no way replaces the
original patient report or
the original chest CT
scan; both are still
available to be viewed and
used at the discretion of
the physician.


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


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

Contrast Non-contrast Non-contrast Non-contrast Same

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

Main image quality
DICOM
DICOM
DICOM
Same

Visual output in the form a
Region of Interest or ROI
(intended for informational
purposes only). The
estimated visual output can
be viewed by the physician
in a diagnostic image
viewer. The physician’s
standard method for
viewing unaltered chest CT
scans in PACS will remain
available to them even if the
subject device is being used.
However, the physician will
also have an option to view
the visual output estimated
by the subject device as a

Outputs a visual
representation of
estimated coronary artery
calcium segmentation
(intended for
informational purposes
only). The estimated
calcium segmentation can
be viewed by the
physician in a diagnostic
image viewer. The
physician’s standard
method for viewing
unaltered chest CT scans
in PACS will remain
available to them even if
the subject device is


being used. However, the
physician will also have
an option to view the
calcium segmentation
estimated by the subject
device as a separate series
within PACS.

Optional to copy result to
clipboard, insert in report,
DICOM Secondary Capture

Yes, estimated exact
Agatston-equivalent score
and binary output
(presence/absence)

Yes, Coronary
Calcium Detection
Category and exact
Agatston score
4 detection categories

Qualified medical
professionals such as
cardiologists or radiologists

Intended location
Medical facility
Medical facility
Medical facility
Same

Measurement scale
Agatston-equivalent units
Agatston-equivalent units
Agatston units
Same


Correspondent Contact Mr. Michael Pogose


Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)


Device Description Summary 21 CFR 807.92(a)(4)

in reviewing the images, making measurements and writing a report.

Intended Use/Indications for Use 21 CFR 807.92(a)(5)


Comparison Feature
Predicate Device: Rapid NCCT Stroke
Subject Device: Methinks NCCT Stroke

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

Methinks NCCT Stroke is a radiological
computer aided triage and notification software
indicated for use in the analysis of (1) non-
contrast head CT (NCCT) images. The device is
intended to assist hospital networks and trained
clinicians in workflow triage by flagging and
communicating suspected positive findings of
(1) Intracranial Hemorrhage (ICH) and (2) Large
Vessel Occlusion (LVO) of the ICA, MCA-M1
and MCA-M2.
Methinks NCCT Stroke uses an artificial
intelligence algorithm to analyze images and
highlight cases with detected (1) ICH and (2)
LVO in the cloud in parallel to the ongoing
standard of care image interpretation. The user
is presented with notifications for cases with
suspected ICH or LVO findings via PACS and/or
notifications. Notifications include preview
images that are meant for informational
purposes only, and are not intended for
diagnostic use beyond notification.
The device does not alter the original medical
image, and it is not intended to be used as a
primary diagnostic device. The results of
Methinks NCCT Stroke are intended to be used
in conjunction with other patient information and
based on professional judgment to assist with
triage/prioritization of medical images. Notified
clinicians are ultimately responsible for
reviewing full images per the standard of care.
Methinks NCCT Stroke is for adults only.
Cautions:
● All patients should get adequate care for
their symptoms including CTA and/or
other appropriate care per the standard
clinical practice, irrespective of the device
output.
● The device is not intended to be a rule-out
device and for cases that have been
processed by the device without
notification for “LVO Suspected” should
not be viewed as indicating that LVO is
excluded. All cases should undergo CTA,
per the standard stroke workup.
Limitations:
• The device does not replace the need
for CTA in ischemic stroke workup, it
provides workflow prioritization and
notification only.


● Rapid ICH has been shown to reliably
identify hemorrhages of ≥ 0.4ml.
Contraindications/Exclusions
● Patient Motion: excessive motion leading
to artifacts that make the scan technically
inadequate.
● Hemorrhagic Transformation, Hematoma
● Very thin or no Ventricles.

User
Trained Clinicians
Trained Physicians

Technology
AI/ML/Neural Network
AI/ML/Neural Network

The device does not highlight or direct a user’s
attention to a specific location in the image file.

Presentation of a preview of the study for initial
assessment not meant for diagnostic purposes.
The device operates in parallel with the standard
of care.

Device does not mark, highlight, or direct users’
attention to a specific location in the original
image.

Clinical SoC Workflow
In parallel to
In parallel to

Two cascaded functions (ICH then LVO) using
three integrated algorithms.

Single algorithm with two different outputs (ICH
and LVO).


Sensitivity (95% CI)
Specificity (95% CI)

Table 2. Performance of the readers vs Methinks NCCT-LVO in the reader study.


Parameter
Mean
95% CI Lower
95% CI Upper

Time to notification of NCCT-ICH (minutes)

Time to notification of NCCT-LVO (minutes)

Table 3. Time to notification of Methinks NCCT Stroke.


Gender
Measure
N
Estimate
Lower 95% CI
Upper 95% CI

Table 4. performance metrics NCCT-ICH by Gender.


Age
Measure
N
Estimate
Lower 95% CI
Upper 95% CI

Table 5. performance metrics NCCT-ICH by Age.


Slice Thickness
Measure
N
Estimate
Lower 95% CI
Upper 95% CI

Table 6. performance metrics NCCT-ICH by Slice Thickness.


Vendor Machine
Measure
N
Estimate
Lower 95% CI
Upper 95% CI

Table 7. performance metrics NCCT-ICH by Vendor Machine.


Table 8. performance metrics NCCT-ICH by hemorrhage volume.


Table 9. performance metrics NCCT-ICH by hemorrhage sub-type.


Table 10. performance metrics NCCT-LVO by Gender.


Table 11. performance metrics NCCT-LVO by Age.


Table 12. performance metrics NCCT-LVO by Slice Thickness.


Table 13. performance metrics NCCT-LVO by Vendor Machine.


LVO Subgroups
Measure
N
Estimate
Lower 95% CI
Upper 95% CI

Table 14. performance metrics NCCT-LVO by LVO subgroups.


Table 16. performance metrics NCCT-LVO by non-LVO subgroups.


Company Name
NeuroSpectrum Insights Corp.

376 Main St. Suite 100, Bedminster NJ 07921

Company Representative
Andrew D. Stewart, CEO

Official Correspondent
James Luker, Innolitics


Common Name
Neuroanatomy measuring software


NeuroQuant (K170981)
Primary Predicate Device

Medical image
management and
processing system

Picture archiving and
communications system

• Software package
• Operates on off-the-shelf
hardware (multiple
vendors)

Client: Supports Windows
11 or MAC OS 12
Server: Ubuntu 23.04 LTS

Equivalent-
Both the subject and predicate devices
are software devices (SaMD) which run
on industry standard computing
hardware and Operating Systems. The
GyriCalc device has been tested to
confirm that it meets it’s stated
requirements and performs as intended
on the stated operating system(s).
GyriCalc does not support the Linux
OS. This difference does not affect the
safety or effectiveness as compared to
the NeuroQuant predicate device.


Fully automated MR
imaging post-processing
medical device software
which includes:
-automatic labeling,
visualization and
volumetric quantification
of brain structures from a
set of MR images and
returns segmented images
and morphometric reports.
(Morphometric
measurements based on
3D T1 MRI series)

Fully automated MR imaging
post-processing medical
device software which
includes:
-automatic labeling,
visualization and volumetric
quantification of brain and
lesions from a set of MR
images and returns segmented
images and morphometric
reports.
(Morphometric measurements
based on 3D T1 MRI series)

Equivalent-
The primary functionality is the same
with the exception that the subject
GyriCalc device does not include lesion
labeling or volumetric quantification of
such lesions.
As lesion detection is not intended to be
performed by GyriCalc, its absence
does not affect Intended Use, safety or
effectiveness comparison of the subject
and predicate devices.
The subject device measurements
include volume, area and gyrification
whereas the predicate device provides
only volume measurement. The
addition of area and gyrification
measurements are considered
technological characteristics which are
supported by clinical performance
testing. As the area and gyrification are
also measurements, they do not add a
new ‘intended use’ and do not affect the
safety and/or effectiveness of the
subject device as compared to the
predicate device or raise new questions
relating to safety and/or effectiveness.

- Automated measurement
of brain tissue structures
for volume, area and
gyrification.
- Automatic segmentation
and
quantification of brain
structures using deep
learning

• Automated measurement of
brain tissue volumes and
structures and lesions
• Automatic segmentation and
quantification of
brain structures using a
dynamic probabilistic
neuroanatomical atlas, with
age and gender specificity,
based on the MR image
intensity

Equivalent-
The design and technological
characteristics of the subject GyriCalc
device and the predicate NeuroQuant
device are equivalent. Both devices are
software medical devices (SaMD) and
utilize DICOM MRI images of the
brain which are automatically
segmented into regions and then
perform measurements.
The subject device measurements
include volume, area and gyrification
whereas the predicate device provides
only volume measurement. The
addition of area and gyrification are
considered technologic characteristics
which are supported by clinical
performance testing. As the area and


gyrification are also measurements,
they do not add a new ‘intended use’
and do not affect the safety and/or
effectiveness of the subject device as
compared to the predicate device or
raise new questions relating to safety
and/or effectiveness.
Differences:
-GyriCalc does not include lesion
quantification functionality whereas the
NeuroQuant predicate does. Lesion
quantification functionality is not an
aspect of GyriCalc’s intended use and
does not affect the safety or
effectiveness as compared to the
predicate device.
-GyriCalc’s automated segmentation
utilizes FreeSurfer’s robust SynthSeg
algorithm whereas the predicate device
uses a dynamic probabalistic
neuroanatomical atlas for its automated
segmentation functionality. GyriCalc’s
segmentation results have been
validated using an ‘expert reader’ study.
Note: NEUROPHET (K220437) has
been added as a Reference device to
support the technological characteristic
of the use of FreeSurfer for
segmentation initialization. A separate
comparison table is provided for the
reference device.
- GyriCalc does not include gender
specificity. Gender specificity is not
necessary for GyriCalc to perform its its
intended use in a safe and effective
manner.
The differences do not affect the safety
or effectiveness as compared to the
predicate device and are supported by
clinical performance testing.

Automated internal
pipeline that performs:

Equivalent -
The subject device and the predicate


- artifact correction
- segmentation
- volume calculation
- gyrification analysis
- report generation

- artifact correction
- segmentation
- lesion quantification
- volume calculation
- report generation

have similar processing architectures,
with the exception that the subject
device also uses gyrification analysis
for measuring Local Gyrification Index
(LGI). This additional technological
characteristic (i.e., gyrification analysis)
does not raise different questions of
safety and effectiveness. The
functionality has been supported by
performance testing.
Additionally, as previously stated,
GyriCalc does not include lesion
quantification as it is not within the
scope of its intended use/indications.

• MRI scanner: 3D T1
MRI scans acquired with
specified protocols from
1.5 and 3 Tesla MR
imaging devices.
• GyriCalc supports
DICOM format as input

• MRI scanner: 3D T1 MRI
scans acquired with
specified protocols
• NeuroQuant Supports
DICOM format as input

Equivalent
GyriCalc performance has been
successfully tested on DICOM images
from 1.5 and 3.0 Tesla MR imaging
devices. The available information on
the NeuroQuant predicate device does
not appear to specify the magnet
strength. However, the following note
in the NeuroQuant Clinical Training
material states that “Some NeuroQuant
parameters vary depending on scanner
manufacturer & field strength”. This
supports that NeuroQuant supports
various magnet strengths.

- Provides volumetric
measurements of brain
structures, including
gyrification information
- Includes segmented color
overlays and
morphometric reports
- The information is
provided as a .pdf report.

- Provides volumetric
measurements of brain
structures and lesions
- Includes segmented color
overlays and
morphometric reports
- Automatically compares
results to reference
percentile data and to prior
scans when
available
- Supports DICOM format as
output of results that
can be displayed on DICOM
workstations and

Equivalent
Both the GyriCalc subject device and
the NeuroQuant predicate device
provide volumetric measurements of
brain structures and segmented color
overlays and
morphometric reports.
Differences-
The GyriCalc device provides
gyrification information whereas
NeuroQuant does not.
This additional technological
characteristic (i.e., gyrification analysis)
does not raise different questions of
safety and effectiveness. The


NeuroQuant (K170981)
Primary Predicate Device

Picture Archive and
Communications Systems

functionality has been supported by
performance testing.
GyriCalc does not compare results to
reference
percentile data and to prior scans. This
functionality is not within the scope of
GyriCalc’s intended use/indications as
GyriCalc is intended for quantification
rather than comparison at this time.
However, GyriCalc does include
‘sample values’ which are supported by
the data used in the performance
validation testing.
GyriCalc does not output DICOM for
display on PACS devices. GyriCalc’s
sole output is a .pdf report which can be
viewed on standard .pdf reading
applications or may be printed.
The stated differences do not alter the
intended use, safety or performance of
the GyriCalc device as compared to the
NeuroQuant predicate device.

Provides morphometric
measurements based on
3D T1 MRI series

-Plane: Sagittal, Axial
-Mode: –3D
-Type: T1 weighted
-Matrix: 256 x 256
-Resolution: Ideally
isotropic with a voxel size
of 1mm x1mm x1mm
-NEX/NSA: 1
-Slice Thickness: 1 mm

Plane –sagittal
Mode –3D
T1 weighted
Matrix –192 x 192
NEX / NSA 1
Slice thickness –1.2 mm
Spacing –1.2 mm
Number of slices –160 -170
FOV 24 – 25.6

Equivalent-
GyriCalc’s MR Scan parameters are
mainly the same (equivalent) to the
NeuroQuant predicates parameters.
GyriCalc’s parameters are consistent
with optimizing the images for analysis
by the GyriCalc software. However,
there are potentially minor variations
between the parameters of the two
devices which do not alter the safety,
effectiveness or performance of the
GyriCalc device.

For use in routine patient
care as a support tool for

For use in both clinical trial
research and routine patient

Equivalent-
GyriCalc does not explicitly intend the


GyriCalc results are
documented in a pdf report
which is available to the
clinician

A report is generated
Results are provided in a
standard DICOM format as
additional MR series that can
be displayed on third-party
DICOM workstations and
PACS.

Equivalent-
GyriCalc’s sole output is a .pdf report
which can be viewed digitally using
standard .pdf reading software as well
as can be printed if desired.
GyriCalc does not provide DICOM
series which can be viewed on third-
party DICOM workstations and PACS
as this functionality is not required for
GyriCalc to perform its intended use.
The absence of DICOM series output
does not raise new questions relating to
the safety or effectiveness of the
GyriCalc device.

No information is publicly
available on cybersecurity.

Equivalent (or better)
The K170981 submission of
NeuroQuant did not contain specific
information related to cybersecurity. In
recent years, the requirements related to
cybersecurity have greatly evolved.
GyriCalc utilizes current ‘state of the
art’ cybersecurity processes and
controls which align with FDA’s
current guidance and recommendations.

GyriCalc performance was
evaluated by comparing
segmentation accuracy
with expert manual
segmentations and by
measuring segmentation
reproducibility between
same subject scans.
The system yields
reproducible results that
are well correlated with
computer-aided expert
manual segmentations.
GyriCalc’s segmentation
accuracy compared to
expert manual
segmentations of 3D T1

NeuroQuant performance was
evaluated by comparing
segmentation accuracy with
expert
manual segmentations and by
measuring segmentation
reproducibility between same
subject scans.
The system yields
reproducible results that are
well correlated with
computer-aided expert manual
segmentations.
NeuroQuant’s segmentation
accuracy compared to expert
manual segmentations of 3D
T1

Equivalent
The performance of GyriCalc and
NeuroQuant was verified using
comparison against expert manual
segmentation. The results of testing
have confirmed equivalent
performance.
GyriCalc has equivalent segmentation
accuracy performance for the major
cortical regions is equivalent to the
NeuroQuant predicate.
Note 1: GyriCalc does not perform
subcortical brain structures.
Note 2: NEUROPHET (K220437) has
been added as a Reference device to
support the technological characteristic
of the use of FreeSurfer for


NeuroQuant (K170981)
Primary Predicate Device

MRI scans was evaluated
using Dice’s coefficient
metric. The results were in
the range of 92-99% with
an average of 95%
confidence.
Volume Measurements:
GyriCalc’s mean
percentage absolute
volume difference of the
major cortical regions was
in the range of 0.45 -12.1
%
Area Measurements:
GyriCalc’s mean absolute
surface area error was in
the range of 0.33 - 12.6 %.
Gyrification
Measurements:
GyriCalc’s mean absolute
gyrification Index error
was in the range of 0.04 -
0.89%.
Description of Subjects:
The imaging data was
collected retrospectively
from a population of
anonymized patients 2-3
years (24-36 months) with
curated clinical records.
Safety and Effectiveness:
The measurements met the
predetermined acceptance
criteria.
Adverse Events:
As the clinical
performance testing was
performed retrospectively
on previously acquired T1
weighted MRI scans, there
were no adverse events

MRI scans was evaluated
using Dice’s coefficient
metric. For major subcortical
brain structures
Dice’s coefficients are in the
range of 80-90% and for
major cortical regions are in
the range of 75-85%. For
lesion segmentations
evaluated separately using 3D
T1 and T2 FLAIR MRI scan
pairs of subjects with brain
lesions, Dice’s coefficient
exceeds 80%.
Brain structure segmentation
reproducibility of repeated 3D
T1 MRI scans for same
subjects
was evaluated by using the
percentage absolute volume
differences. The mean
percentage
absolute volume differences
for all major subcortical
structures were in the range of
1-5%. Brain
lesion segmentation
reproducibility was evaluated
separately using 3D T1 and
T2 FLAIR MRI
repeated scan pairs of subjects
with brain lesions. The mean
absolute lesion volume
difference
was less than 0.25cc, while
the mean percentage lesion
absolute volume difference
was less than 2.5%.

segmentation initialization. A separate
comparison table is provided for the
reference device.
Volume Measurements:
GyriCalc performed in an equivalent
manner to the NeuroQuant in terms of
volumetric measurements. (Note:
NeuroQuant reported on major
subcortical structures rather than the
major cortical structures)
The NeuroQuant predicate device does
not include area or gyrification
measurements. These ‘Technological
Characteristics’ are supported by the
results of the clinical performance
testing and do not raise new questions
relating to safety and/or effectiveness as
compared to the predicate device.
GyriCalc does not perform lesion
segmentations or quantification of
lesions as this functionality is not within
it’s stated intended use/indications. As
lesion functionality is not within
GyriCalc’s intended use, the lack of
such functionality does not raise new
questions related to safety or
effectiveness of the GyriCalc device.


Medical image management
and processing system

GyriCalc is intended for
automatic labeling,
visualization, and
quantification including
volume, surface area and
gyrification analysis (i.e.,
gyrification index) of
segmentable brain structures
from a set of MR images.
GyriCalc is intended to be
used by qualified personnel
and interpreted by a qualified
clinician.

Neurophet
AQUA is
intended for
Automatic
labeling,
visualization
and volumetric
quantification of
segmentable
brain
structures from a
set of MR
images.
Volumetric
data may be

Equivalent -
Both the subject device (GyriCalc) and the
reference device (Neurophet AQUA) are intended
to be used for automatic labeling, visualization,
volumetric quantification of segmentable brain
structures from a set of MR images.
The subject device measurements include volume,
area and gyrification whereas the reference device
provides only volume measurement. The addition
of area and gyrification measurements are
considered technological characteristics which are
supported by clinical performance testing. As the
area and gyrification are also measurements, they
do not add a new ‘intended use’ and do not affect
the safety and/or effectiveness of the subject


GyriCalc is not intended to be
used for visualization or
quantification of neurologic
lesions.
GyriCalc is intended for
children between 24 to 36
months of age.

device as compared to the reference device or
raise new questions relating to safety and/or
effectiveness.
GyriCalc does not include a normative database
with which to compare brain structures to ‘normal’
patients. This functionality is not needed as
GyriCalc is intended for visualization and
quantification only at this time. However,
GyriCalc does include ‘reference values’ which
are supported by the data used in the performance
validation testing.
For clarity, GyriCalc has added an explicit
statement that the device is intended to be used by
qualified personnel and interpreted by a qualified
clinician. The reference Neurophet AQUA device
Indications statement does not state this explicitly
but it is assumed as Neurophet AQUA is an Rx
only device.

- MRI scanner: 3D T1
scans acquired with
specified protocols
- Supports DICOM
format as input.

- Automated
measurement of brain
tissue volumes and
structures.
- Automatic
segmentation and
quantification of brain
structures using deep
learning.

- Automated
measurement of
brain
tissue volumes
and
structures
- Automatic
segmentation and
quantification of
brain
structures using
deep
learning

Equivalent-
Both the subject GyriCalc and Reference
NEUROPHET device perform segmentation based
on deep-learning methodologies whereas the
Primary Predicate device utilizes a technically
similar ‘atlas-based’ segmentation methodology.
GyriCalc’s segmentation accuracy compared to
expert manual segmentations of 3D T1
MRI scans was evaluated using Dice’s coefficient
metric. The results were in the range of 92-99%
with an average of 95% confidence.
The results of the segmentation support that the
subject GyriCalc device is as safe and effective as
the reference device.


confounders for patients in the test dataset.


Ataxia, exotropia, headaches, macrocephaly, microcephaly, optic nerve hypoplasia, orbital mass, spastic
hemiparesis, nystagmus, spastic diplegia, suspected pituitary disorder


Asymmetry of hippocampus, benign ventricular cyst, ear infection, focal cortical displasia, hyperthyroidism,
macrocephaly, microcephaly, neonatal infarction, orbital dermoid

* some patients with multiple reasons for MRI


specified regions of the brain are reported below.


DHT8B: Division of Radiological Imaging Devices and

Office of Product Evaluation and Quality


Radiological computer aided triage and
notification software

Radiological Computer-Assisted Triage
And Notification Software


Predicate Trade Name (Primary
Predicate is listed first)

Legally Marketed Predicate Devices: 21 CFR 807.92 (a) (3)


InferRead CT Stroke.AI
K211179
(Predicate device)

Radiological computer aided
notification software indicated
for use in the analysis of non-
contrast head CT images of
adult patients. The device is
intended to assist trained
radiologists in workflow triage
by flagging and communicating
suspected positive findings of
Intracranial Hemorrhage (ICH).

Radiological computer aided
triage and notification
software for use in the
analysis of Non-Enhanced
Head CT images. The device
is intended to assist hospital
networks and trained
radiologists in workflow triage
by flagging suspected
positive findings of
Intracranial Hemorrhage
(ICH).

User population
Radiologist
Radiologist
Same

Presentation of a preview of
the study for initial
assessment not meant for
diagnostic purposes.
The device operates in
parallel with the standard of
care, which remains the
default option for all cases


Standard off-the-shelf server or
virtual server

Acquires medical image data
from DICOM compliant imaging
devices and modalities

None – software only
application. The software
application does not deliver or
depend on energy delivered to
or from patients

Materials
N/A – Software only device
N/A – Software only device
Same

Biocompatibility
N/A – Software only device
N/A – Software only device
Same

Sterility
N/A – Software only device
N/A – Software only device
Same

Electrical Safety
N/A – Software only device
N/A – Software only device
Same

Mechanical Safety
N/A – Software only device
N/A – Software only device
Same

Chemical Safety
N/A – Software only device
N/A – Software only device
Same

Thermal Safety
N/A – Software only device
N/A – Software only device
Same

Radiation Safety
N/A – Software only device
N/A – Software only device
Same


Feature
Predicate device
Subject device
Comment


The intended use of the device
YSIO X.pree is to visualize
anatomical structures of
human beings by converting an
X-ray pattern into a visible
image.
The device is a digital X-ray
system to generate X-ray
images from the whole body
including the skull, chest,
abdomen, and extremities. The
acquired images support
medical professionals to make
diagnostic and/or therapeutic
decisions.
YSIO X.pree is not for
mammography examinations.

Updated state-
of-the-art
generator with
equal performance

X-ray techniques
Radiography
Radiography
Same

Updated collimator
with
equal performance

Combined
Applications to
Reduce Exposure

Field selection via touch user
interface and virtual AEC
overlay on the camera image


Operating system Windows 10
Operating system Windows 10
Same

Operated via touch screen
Operated via touch screen
Same

AI-based Auto Cropping
AI-based Auto Cropping
Same

Acquisition and Image
processing parameters selected
via clinical protocols

Table with fixed detector and
table with bucky

Updated table
hardware with
equal performance

Wall stand with fixed detector
and wall stand with bucky

Updated wall stand
hardware, new
wireless detector
configurations

Live camera for patient
positioning and collimation

Cropping
AI-based auto-cropping
AI-based auto-cropping
Same

Status Indicator Lights at tube
stand and wall stand


Organization and Reference
Title of Standard

Medical Electrical Equipment - Part 1: General
Requirements for Safety

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

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

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

Medical electrical equipment - Part 2-54: Particular requirements
for the basic safety and essential performance of X-ray equipment
for radiography and radioscopy

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

Medical devices – Application of usability engineering tomedical
devices

Medical devices – application of risk management tomedical
devices

Medical device software - Software life cycle processes

Medical electrical equipment - Radiation dose documentation -
Part 1: Radiation dose structured reports for radiography and
radioscopy

Digital Imaging and Communications in Medicine(DICOM) Set

Biological evaluation of medical devices – Part1: Evaluation and
testing within a risk management process

Table 8: Non-clinical performance testing


Pixium 3543EZ3
Pixium 2430EZ
Pixium 2430EZ3
Comparison to

(predicate (predicate (subject predicate

Sensor Technology
Amorphous Silicon
Amorphous Silicon
Amorphous Silicon
same

Scintillator
Cesium Iodide (CsI)
Cesium Iodide (CsI)
Cesium Iodide (CsI)
same

Pixel pitch
99 µm
148 µm
99 µm
same as 3543EZ3

Maximum resolution
5 lp/mm
3.4 lp/mm
5 lp/mm
same as 3543EZ3

Table 8-2: Comparison of the new detector X.wi-D24 (Pixium 2430EZ3) to the predicates detectors


Medical Solutions USA, Inc.
40 Liberty Boulev

Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and


This modification includes re-training the model and is an update
to the model weights (and optionally hyperparameters) based on a
combination of new and existing training and tuning data,
enhancing its ability to generalize and improve performance on
real-world cases while maintaining the model architecture. No
changes are made to the deployment environment or inference
pipeline, only the trained parameters (model weights) are updated.
● Bitewing Caries Detection Model
● Bitewing Fillings/restorations, Fixed Prostheses, and
Implants Detection Model
● Periapical Caries Detection Model
● Periapical Fillings/restorations, Fixed Prostheses, and
Implants Detection Model
● Panoramic Caries Detection Model
● Panoramic Fillings/restorations, Fixed Prostheses, and
Implants Detection Model
Re-training will be triggered if performance or data drift metrics are
observed. Performance drift metrics include lesion or case level
sensitivity, case level specificity, false positive rate per image, and
DICE score. Data drift metrics including Population Stability Index
(PSI) and Statistical Distribution Changes are evaluated on a
quarterly basis.

The goal is to ensure the device remains safe and effective while
enhancing the device diagnostic accuracy for detecting dental caries,
restorations, fixed prostheses, and implants.

Re-training of each Condition Detection Model with new data to
maintain/improve its performance will be followed by performance
testing and a comparison of the modified Condition Detection
Model to the reference models i.e. most recent model version and
the original cleared model version (using model-specific
performance metrics) and verification and validation.
The Condition Detection modification will not change the intended
use/instructions for use cleared under K240003, hence, the overall
standalone study protocol methodology for the modifications
implemented under the approved PCCPs is aligned with the


predicate Velmeni for Dentists cleared under K240003. The
modifications do not affect the relevance of the study endpoints,
which were originally chosen based on current dental practices.
The acceptance criteria for Sensitivity , Specificity and Average
False Positives have been updated to match the lower bounds of
confidence interval demonstrated by the originally cleared models'
standalone results. The new models will be evaluated on a
combined test dataset with balanced ratio of historical and new
data for validation to avoid overfitting historical data from repeated
use. The new test data is fully independent on a site-level from
training/tuning data, and the test dataset remains at least 50% US
data.
Since the device remains unchanged from the version cleared
under K24003, the clinical test results under K240003 remain
applicable and MRMC results concluded the effectiveness of the
V4D software in assisting readers to identify more caries and
identify more fixed prostheses, implants, and restorations
correctly.

The modified model will be locked prior to the evaluation. If the
predefined PCCP criteria is met, the device will be updated
manually and available globally for all the end users (global
availability). After the release, the rollout is accompanied by an
on-screen pop-up notification with the updated device version and
link to User manual that covers the model changes and resulting
performance characteristics. The latest device version will also be
reflected on the Support tab for future user awareness.
Additionally, the support tab will include a link to the updated User
manual reflecting the modification implemented under the
approved PCCP and updated standalone performance results.

These updates maintain or enhance the model's ability to
generalize across different patient demographics, radiograph
modalities, and clinical scenarios. This ensures that the model
continues to perform reliably in aiding dental practitioners in the
detection and localization of dental conditions lesions on bitewing,
periapical, and panoramic radiographs.
Benefit-Risk Analysis:
Benefits: Maintained or improved performance, generalization
ability, prevention of subgroup biases
Risks: Model degradation, overfitting, misclassification,
Risk Mitigations:
Cross-validation, early stopping, bias monitoring, training data
composition, performance evaluation


Classification
Class II, 21 CFR 892.1750


Predicate Classification
Class II, 21 CFR 892.1750


Thoracic VCAR with GSI Pulmonary Perfusion

Reference Classification
Class II, 21CFR 892.2050


Common Name
Computed tomography x-ray system
Same

The Thirona LungQ software provides reproducible CT values for
pulmonary tissue and specified endobronchial implants which is
essential for providing quantitative support for diagnosis, treatment
planning and follow up examination. The LungQ software can be used
to support physician in the diagnosis and documentation of pulmonary
tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D
segmentation and isolation of sub-compartments, volumetric analysis,
density evaluations, estimated chronic perfusion defect analysis,
fissure evaluation and reporting tools are provided.

Segmentation
Provides 3D segmentation
Same

Provides Segmentation of the:
• Left Lung
• Right Lung
• Left Upper Lobe
• Left Lower Lobe

Table 1: Substantial Equivalence Comparison between Subject and Predicate


• Right Upper Lobe
• Right Middle Lobe
• Right Lower Lobe
• Pulmonary (sub)segments

Provides segmentation of specified endobronchial implants

Ability to measure volume
for:
• Both Lungs
• Left Lung
• Right Lung
• Left Upper Lobe
• Left Lower Lobe
• Right Upper Lobe
• Right Middle Lob
• Right Lower Lobe
• Pulmonary (sub)segments

Ability to measure volume at multiple density ranges for:
• Both Lungs
• Left Lung
• Right Lung
• Left Upper Lobe
• Left Lower Lobe
• Right Upper Lobe
• Right Middle Lob
• Right Lower Lobe
• Pulmonary (sub)segments


Ability to measure the 15th percentile density analysis

Fissure Analysis
Ability to perform fissure evaluations
Same

Ability to report the number of specified endobronchial implants in the
lungs.

Estimated chronic
perfusion defect analysis

Ability to report estimated chronic perfusion defect quantification for:
• Both Lungs
• Left Lung
• Right Lung
• Left Upper Lobe
• Left Lower Lobe
• Right Upper Lobe
• Right Middle Lob
• Right Lower Lobe
• Pulmonary (sub)segments

Analyzed Data Output
Provides a report
Same


Theprimaryfunctionof
ARTAssistantistofacilitate
imageprocessingwithimage
registrationandsyntheticCT
(sCT)generationinadaptive
radiationtherapy.Thisenables
userstometiculouslydesignART
plansbasedontheprocessed
images.

Itisusedbyradiationoncology
departmenttoregister
multi-modalityimagesand
segment(non-contrast)CT
images,togenerateneeded
informationfortreatment
planning,treatmentevaluation
andtreatmentadaptation.

MRIPlannerisasoftware-only
medicaldeviceintendedforuse
bytrainedradiationoncologists,
dosimetristsandphysiciststo
processimagesfromMRI
systemsto
1)providetheoperatorwith
informationoftissueproperties
forradiationattenuation
estimationpurposesinphoton
externalbeamradiotherapy
treatmentplanning,andto
2)derivecontoursforinputto
radiationtreatmentplanningby
assistinginlocalizationand
definitionofhealthyanatomical
structures.
MRIPlannerisnotintendedto
automaticallycontourtumorsor

RayStationisasoftwaresystemfor
radiationtherapyandmedical
oncology.Basedonuserinput,
RayStationproposestreatment
plans.Afteraproposedtreatment
planisreviewedandapprovedby
authorizedintendedusers,
RayStationmayalsobeusedto
administertreatments.
Thesystemfunctionalitycanbe
configuredbasedonuserneeds.


tumorclinicaltargetvolumes.
MRIPlannerisindicatedfor
radiotherapyplanningofadult
patientsforprimaryand
metastaticcancersinthebrain
andhead-neckregions,aswellas
softtissuecancersinthepelvic
region.
MRIPlannergeneratessynthetic
CTimagesforradiation
attenuationestimationpurposes
forthepelvis,brainand
head-neckregionsonly.MRI
Plannergeneratesautomatically
derivedcontoursofthebladder,
colonandfemoralheads,for
prostatecancerpatientsonly.

OperatingSystem Windows Windows Windows Windows

ImageConversionAlgorithm Deeplearning N/A MachineLearning MachineLearning


Autorigidregistration:
CT,MRI,PET
Autodeformableregistration:
CT,MRI,CBCT


GE Hualun Medical Systems Co., Ltd.
No.1, Yong Chang North Road, Beijing Economic Technological Development
Zone, 100176 Beijing P.R. China

Kenny Ma
Manager, Regulatory Affairs, WHXR
GE Hualun Medical Systems Co., Ltd.
Email: Kenny.Ma@gehealthcare.com
Contact Phone Number: +86 (181) 01130591

Christopher Paulik
Senior Regulatory Affairs Manager
GE HealthCare (GE Medical Systems, LLC)
Email: Christopher.A.Paulik@gehealthcare.com
Contact Phone Number: +1 (262) 8945415

Regulation Name:
Stationary X-Ray System

Discovery XR656 HD with VolumeRad (K191699)
21CFR 892.1680 (KPR, MQB)
Class II

Definium Pace Select (K231892)
21CFR 892.1680 (KPR, MQB)
Class II

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


Specification
Predicate Device
Proposed Device
Discussion of differences

Discovery XR656 HD
Definium Tempo Select
between Definium Tempo

General Purpose Digital
Radiographic Imaging System

The Discovery XR656 HD is intended
to generate digital radiographic
images of the skull, spinal column,
chest, abdomen, extremities, and

The Definium Tempo Select is
intended to generate digital
radiographic images of the skull,
spinal column, chest, abdomen,

Equivalent
The VolumeRAD is
removed from the
proposed device.

Table 1: High-level Comparison of Subject Device to Predicate


other body parts in patients of all
ages. Applications can be performed
with the patient sitting, standing, or
lying in the prone or supine position
and the system is intended for use in
all routine radiography exams.
Optional image pasting function
enables the operator to stitch
sequentially acquired radiographs
into a single image.
The Discovery XR656 HD
incorporates AutoGrid, which is an
optional image processing software
installed as a part of the systems
Helix image processing software.
AutoGrid can be used in lieu of an
anti-scatter grid to improve image
contrast in general radiographic
images by reducing the effects of
scatter radiation.
When the VolumeRAD option is
included on the system, the system
can generate tomographic images of
human anatomy including the skull,
spinal column, chest, abdomen,
extremities, and other body parts in
patients of all ages.
When the VolumeRAD option is used
for patients undergoing thoracic
imaging, it is indicated for the
detection of lung nodules.
VolumeRAD generates diagnostic
images of the chest that aid the
radiologist in achieving superior
detectability of lung nodules versus
posterior-anterior and left lateral
views of the chest, at a comparable
radiation level.
The device is not intended for
mammographic applications.

extremities, and other body parts in
patients of all ages. Applications
can be performed with the patient
sitting, standing, or lying in the
prone or supine position and the
system is intended for use in all
routine radiography exams.
Optional image pasting function
enables the operator to stitch
sequentially acquired radiographs
into a single image.
The device is not intended for
mammographic applications.

User group
Professional Use Only
Professional Use Only
Identical


Distributed software architecture
(Atlas)

One-LCD monitor, Keyboard, Mouse,
Barcode reader

One-LCD monitor, Keyboard, Mouse
and Barcode reader

Changed
The same function for
motion control and the UI
changed with more exam
information synced with
main UI.

DAP software calculation based on
FOV and SID measured by Encoder
after Dose calibration

The depth Camera provides:
1. Live video on main UI

The same depth camera provides
workflow improvement based on
the predicate:
1. Patient size suggestion based
on camera depth
measurement.
2. Detector and ion chamber
outline on video.
3. Patient Snapshot during exam.
4. FOV adjustable from video in
Main UI.

New
This new feature provides
additional observation for
patient positioning.

Equivalent
Same function, different
supplier.

GCC-C4 cabinet as power unit for HV
generator and system

GCC-C5 cabinet as power unit for HV
generator and system

Equivalent.
The GCC-C5 is changed to
accommodate the
generator.

FlashPad HD:
10 x 12 detector (K161942)
14 x 17 detector (K161966)
17 x 17 detector (K181526)

FlashPad Select:
17x17 detector (K210314)

Equivalent
The proposed device only
uses the listed equivalent
17 x 17 detector which is
identical to the reference
product Definium Pace
Select cleared under
K231892.


Specification
Predicate Device
Proposed Device
Discussion of differences

Discovery XR656 HD
Definium Tempo Select
between Definium Tempo

Three detector Size supported at
100 um resolutions:
17 x 17 inch
14 x 17 inch
10 x 12 inch

One detector Size supported at 100
um resolutions:
17 x 17 inch

Identical
Removed 10 x 12 and 14 x
17 detectors.

300kg (distributed loading)
150kg (point loading)

YES – 802.11 wireless (Personal Area
Network)

Equivalent
The table provides same
function with minor travel
range and loading change

5-axes motion controlled with Auto
Positioning overhead tube support
(OTS) from console position and
local manual control

4-axes motion controlled with Auto
Positioning overhead tube support
(OTS) from console position and
local manual control

Changed
Motor and driver changed
with minor specification
change and the supplier
changed

Image Pasting
on Table and
Wall Stand
Mode

Image pasting can be performed at
Wall stand mode and Table mode.
Individual mA adjustable for fixed
mode and ion chamber is
changeable in sub-image is
provided

Changed
The function of individual
mA adjustable for fixed
mode and ion chamber
adjustable in sub-images is
provided. The registration
and image process
algorithm are not changed.

Yes
Virtual grid function for DC (Digital
Cassette) mode

Yes
Virtual grid function in Table, WS
(Wall stand) and DC (Digital
Cassette) mode

Equivalent
The Auto-Grid algorithm is
the identical to the
predicate device whilst
only DC (Digital Cassette)
mode is used.
In the proposed device, we
provided Table, WS and DC
mode Auto Grid which
algorithm is same with the
p redicate.

Auto-tracking between Wall stand
and tube stand vertically (OTS
tracking WS)

Auto-tracking between Wall stand
and tube stand vertically (OTS
tracking WS and WS tracking OTS)

Changed
The tracking methods are
same, just added mutual
tracking feature.


Specification
Predicate Device
Proposed Device
Discussion of differences

Discovery XR656 HD
Definium Tempo Select
between Definium Tempo

Tube can be motorized to defined
position via motorized 5 axis
motion.

Tube can be motorized to defined
position via motorized 4 axis
motion.
Tube can be automatically
angulated according to the input on
tube head console UI.

Equivalent
Auto-position is simpler
since the column rotation
motorization is removed.
The tube angulation is
added, and it is a small
feature since it is only the
tube rotates around its
center. But the auto
positioning method is
equivalent.

The image processing algorithm
provides pre-tuned and
configurable thick and thin regions
to improve contrast and visibility in
over-penetrated and under-
penetrated regions.

The image processing algorithm
uses artificial intelligence to
dynamically estimate thick and thin
regions to improve contrast and
visibility in over-penetrated and
under-penetrated regions.

Changed
The algorithm is the same
but parameters per
anatomy/view are
determined by artificial
intelligence to provide
better consistence and
easier user interface in the
proposed device.


Level P, 24 Campbell Street
Sydney, NSW 2000
Australia


Radiological computer aided triage and notification software
(21CFR892.2080)


Device Name
Annalise Enterprise CXR Triage Trauma


Tension pneumothorax
QFM
0.989 (0.984, 0.994)

Pneumoperitoneum
QAS
0.987 (0.976, 0.994)

Pleural effusion
QFM
0.977 (0.969, 0.984)

Vertebral compression fracture
QFM
0.972 (0.960, 0.982)


Classification Description
21 CFR §
Product Code

System, imaging, pulsed doppler,
ultrasonic

System, imaging, pulsed echo,
ultrasonic

Transducer, ultrasonic, diagnostic
892.1570
ITX

Automated Radiological Image
Processing Software

Diagnostic Intravascular Catheter
870.1200
OBJ*

Common Name Diagnostic Ultrasound System and Transducers


System, imaging, pulsed doppler,
ultrasonic


EPIQ Series Diagnostic Ultrasound System

Feature
Feature: SVS v2
K240850
Comparison

Primary Product
IYN
IYN
Identical to predicate

System, Imaging, Pulsed Doppler, Ultrasonic

Primary
21 CFR 892.1550
21 CFR 892.1550
Identical to predicate

Diagnostic ultrasonic transducer
Ultrasonic pulsed echo imaging
system
Diagnostic intravascular catheter
Automated Radiological Image
Processing Software

Reusable-
Yes
Yes
Identical to predicate

Duration of use
Limited (≤ 24 hours)
Limited (≤ 24 hours)
Identical to predicate

Smart View Select is an automated software
feature that assists you in the selection of
images for analysis with the existing Philips
AutoStrain LV or 2D Auto LV application in
Adult Echo Transthoracic examination. This
feature automatically classifies each acquired
image by view and selects an appropriate set of
images for Left ventricle (LV) analysis. The
classification is based on a Deep Learning AI
interface engine; the selection is a non-AI


algorithm that considers the view classification
and image depth to select the optimal set of
images.
You can launch AutoStrain LV or 2D Auto LV
with the set of images that have been
automatically selected without the need to
review the acquired images and manually
select the views.

AI based neural network for optimal view
selection

The subject SVS software
application utilizes a deep neural
network for view identification
and optimal triplet (A4C, A2C, and
A3C) selection for subsequent LV
Analysis. The neural network is
utilized in a similar way as in the
predicate device for the analysis
standard 2D echo examinations.
The neural network of the subject
device was revised as described in
attachment 002. Performance
testing has demonstrated very
strong correlation between the LV
analysis outputs (EF, GLS) from
clips selected by the subject SVS
software application and clips
manually selected by clinical users.

Yes – the subject SVS software application
uses an additional heuristic logic step, after the
deep neural network identifies the views and
determines a list of 3
clip combinations (triplets), to preferentially
select triplets of shallower scan depths.
Restriction of depth on clinical images is 12-20
cm.

Yes – the subject SVS software application
uses an additional heuristic logic step, after
the deep neural network identifies the views
and determines a list of 3 clip combinations
(triplets), to preferentially select triplets of
shallower scan depths, provided the depth
exceeds 10cm and the variation of depths of
each clips is 1cm or less.

The subject SVS software
application, similar to the predicate
device(K240850), includes
additional heuristic logic step for
preferentially selecting certain scan
depths. The logic was revised in the
subject device. Performance testing
has demonstrated very strong
correlation between the LV analysis
outputs (EF, GLS) from clips
selected by the subject SVS
software application and clips
manually selected by clinical users.
Therefore, the revision in the


EPIQ Series Diagnostic Ultrasound System

Feature
Feature: SVS v2
K240850
Comparison

additional heuristic logic step of the
subject SVS software does not raise
new or different questions of safety
or effectiveness in comparison to
the predicate device K240850.


Affiniti Series Diagnostic Ultrasound
EPIQ Series Diagnostic Ultrasound

Sonography training and clinical
procedures are not included in the
User Manual or with the Affiniti Series
Diagnostic Ultrasound System.

included in the User Manual or with the
EPIQ Series Diagnostic Ultrasound
System.

Clinics, hospitals, and clinical point-of-
care for diagnosis of patients.

Class II
Class II
Identical to predicate

System, Imaging, Pulsed Doppler,
Ultrasonic

Primary Regulation
21 CFR 892.1550
21 CFR 892.1550
Identical to predicate

Diagnostic ultrasonic transducer
Ultrasonic pulsed echo imaging
system
Diagnostic intravascular catheter
Automated Radiological Image
Processing Software

Reusable- Systems and
Yes
Yes
Identical to predicate

Duration of use
Limited (≤ 24 hours)
Limited (≤ 24 hours)
Identical to predicate


Yes – the subject SVS software
application uses an additional
heuristic logic step, after the deep
neural network identifies the views
and determines a list of 3
clip combinations (triplets), to
preferentially select triplets of
shallower scan depths. Restriction of
depth on clinical images is 12-20 cm.

Yes – the subject SVS software
application uses an additional heuristic
logic step, after the deep neural network
identifies the views and determines a list
of 3 clip combinations (triplets), to
preferentially select triplets of shallower
scan depths, provided the depth
exceeds 10cm and the variation of
depths of each clips is 1cm or less.

The subject SVS software application,
similar to the predicate
device(K240850), includes additional
heuristic logic step for preferentially
selecting certain scan depths. The
logic was revised in the subject device.
Performance testing has demonstrated
very strong correlation between the LV
analysis outputs (EF, GLS) from clips
selected by the subject SVS software
application and clips manually selected
by clinical users. Therefore, the
revision in the additional heuristic logic
step of the subject SVS software does
not raise new or different questions of
safety or effectiveness in comparison
to the predicate device K240850.


American Indian or Alaska Native
0.0% (0/71)

Native Hawaiian or Other Pacific Islander


Classification Name:
Magnetic Resonance Diagnostic Device

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

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


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

Marketed By
Canon Medical Systems USA, Inc.


Vantage Galan 3T, MRT-1550, V10.0 with
AiCE Reconstruction Processing Unit for
MR


Item
Subject Device:
Predicate Device:
Notes

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

with AiCE Reconstruction
with AiCE Reconstruction

Processing Unit for MR
Processing Unit for MR

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

Allows screen access to 1st level
operating mode

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

Potential emergency
condition and means
provided for shutdown

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


Subject Device
Predicate Device (K234042)

Classification
Automated Radiological Image
Automated Radiological Image

Name
Processing Software
Processing Software

EFAI BONESUITE XR BONE AGE
PRO ASSESSMENT SYSTEM (EFAI
BAPXR) is designed to view and
quantify bone age from 2D Posterior
Anterior (PA) view of left-hand
radiographs using deep learning
techniques to aid in the analysis of
bone age assessment of patients
between 2 to 16 years old for pediatric
radiologists. The results should not be
relied upon alone by pediatric
radiologists to make diagnostic
decisions. The images shall be with
left hand and wrist fully visible within
the field of view, and
shall be without any major bone
destruction, deformity, fracture,
excessive motion, or other major
artifacts.

 Comparison of Technological Characteristics


fractures, or congenital deformities) in

Environment
Healthcare facility/Hospital
Healthcare facility/Hospital

Intended User
Pediatric radiologist
Pediatric radiologist

Clinical
Bone age assessment
Bone age assessment

Image Input
Complies with DICOM standard
Complies with DICOM standard

Anatomical
Left hand and wrist
Left hand and wrist

Quantitative
Bone age assessment (years)
Bone age assessment (years)


Subsystem
Revolution Apex Elite
Revolution Vibe

(Predicate Device, K213715)
(Proposed Device)

 80 cm patient bore
 Rotation Speeds: 0.23, 0.28, 0.35,
0.4, 0.5, 0.6, 0.7, 0.8, 0.9, and 1.0
seconds per rotation.

 160 mm Z-coverage
 256 rows, 0.625 mm pixel pitch
 Low capacitance backlit
photodiode
 Gemstone Scintillator Material
 Detector Thermal System (DTS)
with higher RPM fans

 Up to 160 mm in Z with 320 mm SFOV; Up
to 40 mm in Z with up to 50 mm SFOV
 256 rows, 0.625 mm pixel pitch within 320
mm SFOV; 64 rows, 0.625 mm pixel within
500 mm SFOV
 Low capacitance backlit photodiode
 Gemstone Scintillator Material
 Detector Thermal System (DTS) with higher
RPM fans


Ultrasonic pulsed doppler imaging system

System, Imaging, Pulsed Doppler, Ultrasonic


One of “Transcerebellar” plane, “Transthalamic” plane, or the
“Transventricular” plane

One of “Median Facial Profile” plane, “Coronal Plane of Upper Lip,
Nose, and Nostrils” plane, or “Orbits, Lenses” plane

Thorax/Chest (Also
referred to as “Heart
Screening Planes”)

One of the “Right Ventricular Outflow Tract” plane, “Three-Vessel
View” plane, “Three-Vessel and Trachea View” plane, “Left Ventricular
Outflow Tract” plane, or “Thorax Four-Chamber Heart View” plane

One of “Bladder Plane ”, “Kidneys Plane”, “Stomach Umbilical Plane“,
or “Cord Insertion Plane”

Do one or more of these elements exist:
● The tibia is present
● The fibula is present

Table 1: AI-1 Outputs / High Level Anatomy Classification Label Criteria


Views the Structure is found in (hence we only predict the visibility of
structures within these views)

Abdominal Aorta
Abdomen Stomach Umbilical

Inferior Vena Cava
Abdomen Stomach Umbilical

Stomach Shadow
Abdomen Stomach Umbilical

Floating Ribs
Abdomen Stomach Umbilical Vein

Umbilical Vein
Abdomen Stomach Umbilical vein

Abdomen Stomach Umbilical, Abdomen Kidneys, Heart Screening Planes,
Thorax 4 Chamber Heart, Spine Sagittal

Face Coronal Upper lip Nose Nostrils, Face Median Facial Profile

Face Median Facial Profile, Face Coronal Upperlip Nose Nostrils

Head Transthalamic, Head Transventricular

Table 3: AI-3 Outputs / Fetal Anatomical Structures and Regions Label Criteria


Parito Occipital Sulcus
Head Transventricular

Head Transventricular, Head Transthalamic

Superior Vena Cava
Heart Screening Planes

Heart Screening Planes, Thorax 4 Chamber Heart


Predicate Device: Sonio Detect (K240406 )

21 CFR 892.1550 - accessory to Ultrasonic Pulsed
Doppler Imaging System
21 CFR 892.1560 - accessory to Ultrasonic Pulsed
Echo Imaging System
21 CFR 892.2050 - Medical Image Management
and Processing System

Qualified and trained healthcare professional
personnel in a professional prenatal ultrasound
(US) imaging environment (this includes
sonographers, MFMs, OB/GYN, and Fetal
surgeons)

- BioticsAI automatically detects views
- BioticsAI automatically detects anatomical
structures within the supported views
- BioticsAI provides an interface to the operator
that shows BioticsAI’s automatic anatomical
findings, allowing the operator to verify the
quality criteria and characteristics of the supported
views.

- Sonio Detect automatically detects views
- Sonio Detect automatically detects anatomical
structures within the supported views
- Sonio Detect automatically verifies the quality
criteria and characteristics of the supported
views.

Artificial Intelligence (Computer Vision)

Table 4: Comparison of Technological Characteristics


Secure cloud-based software compatible with
standard DIMSE integration with ultrasound
systems from GE Medical

Secure cloud-based and stand-alone software
compatible with ultrasound systems from GE
Medical, Samsung, Canon and Philips

BioticsAI requires the following:
- Clinical support for exporting DICOM over
DIMSE to BioticsAI’s DICOM Adapter.
- SaaS accessibility from an internet browser
(recommended browser: Google Chrome).

Sonio Detect requires the following:
- Edge Software (described below) to install on
a server on the same network as the Ultrasound
Machine;
- SaaS accessibility from any internet browser
(recommended browser: Google Chrome).