Refactor of the application workflow; introducing multi-tenancy
capabilities; and improving scalability of cloud deployment.

Revision of the validation strategy to support the validation of a
multi-vendor, multi-field strength algorithm.

The intended patient population of BoneMRI is extended to include
adolescents. The algorithm for the application has not been
changed.

Addition of a Predetermined Change Control Plan to support an
iterative development approach for the machine learning models in
the BoneMRI application.

The algorithm for the Spine region has been re-trained. With
additional data for training and testing, the anatomical region of the
algorithm was extended to include the Cervical Spine and the
Thoracic Spine in addition to the Lumbar Spine.

No changes are made to the algorithm for the Pelvic region. Updates
have been made to improve statistical testing of the algorithm and
to test the algorithm on additional subgroups.

Table 2 Summary of changes for the BoneMRI application


1. Re-training to improve ML
model performance with
additional training data

Re-training of the ML model with additional data to increase the
safety and performance of the device in any of the following
categories:
● Increased accuracy;
● Increased performance for challenging cases such as rare
pathologies or artifacts;
● Increased robustness and generalization of the model.

2. Validation of additional
scanner support

Validation of the ML model (either with or without additional re-
training of the ML model) in order to validate an additional MRI
vendor or field strength.

Table 3 Summary of changes under a Predetermined Change Control Plan


Proprietary Name
Nano-X AI HealthFLD device

Classification Name
Computed tomography x-ray system.


Predicate Device:
Nano-X AI HealthOST device

The HealthFLD device is substantially equivalent to the following Predicate Device:


Primary Predicate Device:
Nano-X AI Ltd. HealthOST Device
(K213944)

The HealthFLD device is an image
processing software that provides
quantitative and qualitative analysis of
the liver from CT images to support
clinicians in the evaluation and
assessment of Fatty Liver. The
HealthFLD software provides
measurements of liver attenuation
(mean HU in a region of interest).
HealthFLD is indicated for use in non-
contrast and contrast CT scans, with
any clinical indication, for patients
aged 18 up to 75. CTs must include a
significant part of the liver. The
HealthFLD device is not intended to
provide a diagnosis or risk assessment
of fatty liver disease.

HealthOST is an image processing software
that provides qualitative and quantitative
analysis of the spine from CT images to
support clinicians in the evaluation and
assessment of musculoskeletal disease of the
spine.
The HealthOST software provides the
following functionality:
• Labelling of T1-L4 vertebrae
• Measurement of height loss in each
vertebra (T1-L4)
• Measurement of the mean
Hounsfield Units (HU) in volume of
interest within vertebra (T11-L4)
HealthOST is indicated for use in patients
aged 50 and over undergoing CT scan for
any clinical indication, that includes at least
four vertebrae in the T1-L4 portion of the
spine (for vertebral height loss) and T11-L4
(for bone attenuation) portions of the spine.
The device is indicated for FBP-
reconstructed images only


Primary Predicate Device:
Nano-X AI Ltd.
HealthOST Device
(K213944)

Non-contrast enhanced
and contrast enhanced

Similar, both devices
detect the target organ
in the scan. The
differences do not raise
different questions of
safety and
effectiveness of the
subject and predicate
devices and evaluation
of the device comprises
the same types of
verification and
validation testing

Comparison of Technological Characteristics


Deep-learning-based
segmentation of the Liver

Deep-learning-based
segmentation of vertebras

Similar, both devices
perform segmentation
of the target organ, in
the same method. The
differences do not raise
different questions of
safety and
effectiveness of the
subject and predicate
devices and evaluation
of the device 5-
6comprises the same
types of verification
and validation testing

HU measurements based
on segmentation and
mean HU in regions of
interest (ROIs)
Indication to user if
outside reference range

HU measurements based
on segmentation and mean
HU in volume of interest
Indication to user if outside
reference range

Same, both devices
measure mean
attenuation (HU) of
selected region within
the organ
Region of interest is
equivalent to volume
of interest

1. Annotation of up to
three (3) Region of
Interest (ROI)
2. Liver density
measured in HU

1. Vertebrae label/name
2. Three (3) lines
representing the
anterior, middle, and
posterior points
measures, together with
relative measurements
3. % Height loss and
relative Genant
category (20)
4. Bone density measured
in HU

Similar, the subject
device provides the
analysis results as liver
attenuation in HU,
same as the predicate
device provides the
bone attenuation in
HU.


Radiological computer aided triage and notification software

QFM, Radiological Computer-Assisted Prioritization Software
For Lesions


Radiological Computer-Assisted Prioritization Software


Predicate Device
CogNet QmTRIAGE
(K220080)

The VinDr-Mammo is
a passive notification
for prioritization-only,
parallel-workflow
software tool used by
MQSA qualified
interpreting physicians
to prioritize patients
with suspicious
findings in the medical
care environment.
VinDr-Mammo utilizes
an artificial intelligence

The MedCognetics
(CogNet)
QmTRIAGETM
software is a passive
notification for
prioritization-only,
parallel-workflow
software tool used by
MQSA qualified
interpreting physicians
to prioritize patients
with suspicious
findings in the medical

A comparison of the technological characteristics with the predicate is summarized below.


information beyond
triage and
prioritization, does not
remove images from
the interpreting
physician’s worklist,
and should not be used
in lieu of full patient
evaluation, or relied
upon to make or
confirm diagnosis.
The VinDr-Mammo
device is intended for
use with complete 2D
FFDM mammography
exams acquired using
validated FFDM
systems only.

QmTRIAGE device is
limited to the
categorization of
exams, does not
provide any diagnostic
information beyond
triage and
prioritization, does not
remove images from
the interpreting
physician’s worklist,
and should not be used
in lieu of full patient
evaluation, or relied
upon to make or
confirm diagnosis.
The QmTRIAGE
device is intended for
use with complete 2D
FFDM mammography
exams acquired using
validated FFDM
systems only.

Notification-
only, parallel
workflow tool

User
Interpreting physician
Interpreting physician
Same


Yes; passive
notification flagged for
review

- Standard 2D FFDM
screening
mammograms
- Biopsy proven cancer
studies (soft tissues and
microcalcifications)
- Biopsy-proven benign
studies

- Standard 2D FFDM
screening
mammograms
- Biopsy proven cancer
studies (soft tissues and
microcalcifications)
- BIRADS 1 and 2
normal/benign cases


- BIRADS 1 and 2
normal cases with 2‐
year follow‐up of a
negative diagnosis
- Bilateral Studies with
4 standard views (LCC,
LMLO, RCC, RMLO)

with 2‐year follow‐up
of a negative diagnosis
- Female patients 22
and older
- Bilateral Studies with
4 standard views (LCC,
LMLO, RCC, RMLO)

-Studies that do not
include all 4 views
-Digital Breast
tomosynthesis studies
- 3D studies
Studies that do not
comply with the
inclusion criteria

- Digital breast
tomosynthesis images
- 2D synthetic views
from tomosynthesis

Similar, different
criteria and
scope are
intended to limit
to specific
mammography
methods. This
does not raise
any questions
regarding safety
or efficacy and
use of
mammography
images

Aids prompt
identification of
cases with
indicated
findings


Presentation of
notification and
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.

The device operates in
parallel with the
standard of care, which
remains the default
option for all cases.
Encapsulated PDF
stored
with original DICOM
study and may be
downloaded and
viewed as a PDF.


Metrics
Mean
Lower 95% CI bound
Upper 95% CI bound

with a two-year follow-up of a negative diagnosis. A table of results is provided below:


A summary of the DDSM dataset characteristics are provided in the table below:


Ethnicity
Representative of the US Population


ground truth. A table of results is provided below:


table of the predicate results is provided below:


Breast Density
RSNA Test set
VinDr Test set


Scanner model
RSNA Test set
VinDr Test set


Lesion type
RSNA Test set
VinDr Test set


ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,
C1:2009/(R)2012 and A2:2010 /(R)2012 Medical Electrical
Equipment - Part 1: General Requirements for basic safety and
essential performance.

IEC60601-1-2: 2020(4.1 Edition), Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential
performance - EMC

IEC 60601-2-18: Edition 3.0 2009-08
Medical electrical equipment - Part 2-18: Particular requirements for
the basic safety and essential performance of endoscopic equipment

IEC60601-2-37:2007 + A1:2015, Particular requirements for the
safety of ultrasonic medical diagnostic and monitoring equipment

ISO 10993-1:2018, Biological evaluation of medical devices -- Part
1: Evaluation and testing within a risk management process.

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

NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment Revision 3


Validation Type
Definition
Acceptance Criteria

Number of correctly detected frames
×100
Total number of frames with nerve

1000
Average latency time of each frame (msec)


Validation Type
Average
Standard Deviation
95% CI

Summary Performance data, Standard Deviations & Confidence Intervals:


Item
Proposed Device
Predicate Device
Remark

follow-up PET, CT, MR data, with which users can
do image registration, lesion segmentation, and
statistical analysis.
uOmnispace.MI Dynamic Analysis application is
intended to display PET data and anatomical data
such as CT or MR, and supports to do lesion
segmentation and output associated time activity
curve.
uOmnispace.MI NeuroQ application is intended to
analyze the brain PET scan, give quantitative results
of the relative activity of different brain regions, and
make comparison of activity of normal brain
regions in AC database or between two studies from
the same patient, as well as provide analysis of
amyloid uptake levels in the brain.
uOmnispace.MI Emory Cardiac Toolbox
application is intended to provide cardiac short axis
reconstruction, browsing function. And it also
performs perfusion analysis, activity analysis and
cardiac function analysis of the cardiac short axis.

and output associated time-activity curve.
NeuroQ application is intended to analyze the
brain PET scan, give quantitative results of the
relative activity of 240 different brain regions, and
make comparison of activity of normal brain
regions in AC database or between two studies
from the same patient, as well as provide analysis
of amyloid uptake levels in the brain.
Emory Cardiac Toolbox application is intended to
provide cardiac short axis reconstruction,
browsing function. And it also performs perfusion
analysis, activity analysis and cardiac function
analysis of the cardiac short axis.


Application
Function name
Proposed device
Predicate
Reference
Remark

Table 2 Substantial equivalent discussion for MM Fusion


Registration
Dot Registration
Yes
Yes
/
Same

Default Layout and C
ustomized Layout
Yes
Yes
/
Functional
Substantial E

Fix threshold segmentation
Yes
Yes
/
Same


Functional Substantial
Equivalent.
Note 4

Table 3 Substantial equivalent discussion for MM Oncology


Application
Function name
Proposed device
Predicate device
Remark

Dynamic Analysis
Automatic cine
Yes
Yes
Same

Table Quantization Statistics
Yes
Yes
Same

Registration
Manual Registration
Yes
Yes
Same

Table 4 Substantial equivalent discussion for Dynamic Analysis


The average score of the proposed device
results is higher than 4 points.

Table 8-1. Validation type and acceptance criteria


Asian(Chinese) data: 106
European data: 160
The United States data: 20


Age
Average score of the proposed device

Gender
Average score of the proposed device

Ethnicity
Average score of the proposed device


Table8-4. Validation type and acceptance criteria


Table 8-5. Sample size information of testing data


Asian(Chinese) data: 80
The United States data: 80


Device Classification Name
Magnetic resonance diagnostic device

Shanghai United Imaging Healthcare Co., Ltd.

The uMR Omega system is indicated for use as a
magnetic resonance diagnostic device (MRDD) that
produces sagittal, transverse, coronal, and oblique cross
sectional images, and spectroscopic images, and that
display internal anatomical structure and/or function of
the head, body and extremities.


Picture archiving and communication system

READY View is a image analysis software that allows
the user to process dynamic or functional volumetric
data and to generate maps that display changes in image
intensity aver time, echo time, lb-vague (Diffusion
imaging) and frequency (Spectroscopy). The
combination of acquired images, reconstructed images,
calculated parametric images, tissue segmentation,
annotations and measurement performed by the clinician
allows multi-parametric analysis and may provide
clinically relevant information for diagnosis.


Item
Proposed Device
Predicate Device
Remark

 The uOmnispace.MR Dynamic
application is intended to provide a general
post-processing tool for time course
studies.
 The uOmnispace.MR MRS (MR
Spectroscopy) is intended to evaluate the
molecule constitution and spatial
distribution of cell metabolism. It provides
a set of tools to view, process, and analyze
the complex MRS data. This application
supports the analysis for both SVS (Single
Voxel Spectroscopy) and CSI (Chemical
Shift Imaging) data.
 The uOmnispace.MR MAPs
application is intended to provide a number
of arithmetic and statistical functions for
evaluating dynamic processes and images.
These functions are applied to the grayscale
values of medical images.
 The uOmnispace.MR Breast
Evaluation application provides the user a

 The Dynamic application is intended
to provide a general post-processing
tool for time course studies.
 MRS (MR Spectroscopy) is intended
to evaluate the molecule constitution
and spatial distribution of cell
metabolism. It provides a set of tools
to view, process, and analyze the
complex MRS data. This application
supports the analysis for both SVS
(Single Voxel Spectroscopy) and CSI
(Chemical Shift Imaging) data.
 The MAPs application is intended to
provide a number of arithmetic and
statistical functions for evaluating
dynamic processes and images. These
functions are applied to the grayscale
values of medical images.
 The MR Breast Evaluation application
provides the user a tool to calculate


tool to calculate parameter maps from
contrast-enhanced time-course images.
 The uOmnispace.MR Brain
Perfusion application is intended to allow
the visualization of temporal variations in
the dynamic susceptibility time series of
MR datasets.
 The uOmnispace.MR Vessel
Analysis is intended to provide a tool for
viewing, manipulating, and evaluating MR
vascular images.
 The uOmnispace.MR DCE analysis
is intended to view, manipulate, and
evaluate dynamic contrast-enhanced MRI
images.
 The uOmnispace.MR United Neuro
is intended to view, manipulate, and
evaluate MR neurological images.
 The uOmnispace.MR Cardiac
Function is intended to view, evaluate
functional analysis of cardiac MR images.

parameter maps from contrast-
enhanced time-course images.
 The Brain Perfusion application is
intended to allow the visualization of
temporal variations in the dynamic
susceptibility time series of MR
datasets.
 MR Vessel Analysis is intended to
provide a tool for viewing,
manipulating, and evaluating MR
vascular images.
 The DCE analysis is intended to view,
manipulate, and evaluate dynamic
contrast-enhanced MRI images.
 The United Neuro is intended to view,
manipulate, and evaluate MR
neurological images.
 The MR Cardiac Analysis application
is intended to be used for viewing,
post-processing and quantitative


 The uOmnispace.MR Flow
Analysis is intended to view, evaluate flow
analysis of flow MR images.

evaluation of cardiac magnetic
resonance data.


Reference
Device#1
uMR
Omega
with uWS-
MR-MRS
(K220332)

Series Registration
Yes
Yes
/
/
/
/
Same

Table 2 Substantial equivalent discussion for Advanced Applications


Parameter Map
Calculation:WO,
WI, TTP, PEI and
MSI


To evaluate the proposed device of automatic ventricular
segmentation, we compared the results with those of the
cardiac function application of predicate device. The
Sørensen–Dice coefficient is used to evaluate consistency.
If dice>0.95, it is considered consistent between the two
devices.

The validation type and acceptance criteria is shown in the Table 1 below:


Product
Marketed by
510(k) Number
Clearance Date

Aplio i900/i800/i700 Diagnostic
Ultrasound System, Software
V7.0 (Primary predicate)

OLYMPUS GF TYPE UC180,
OLYMPUS GF TYPE UCT180 EVIS
EXERA II ULATRASOUND
GASTROVIDEOSCOPE
(Reference device)


Item
MEDIHUB PROSTATE
Quantib Prostate
Substantial

Medical image management
and processing system

Picture archiving and
communications system

Target users
Trained medical professionals
Trained medical professionals
Equivalent

Anatomical site
Prostate
Prostate
Equivalent

• User can approve or reject
results
• User can inspect and edit
prostate segmentation
• User can enter PSA value
and compute PSA density
• User can create and update
regions of interest (ROIs)
• User can add and update
annotations (text) to analysis
• User can manually set a PI-
RADS score using a PI-RADS
interactive worksheet


• Semi-automatic prostate
segmentation
• Multi parametric image
review
• Biparametric combination
image viewer
• Basic image manipulation
tools, Thresholding tool
• User interface to
create/update user generated
ROIs

• Bench testing performed to
test the functionality of the
system
• This included
characterization of the
standalone performance of
the prostate segmentation
algorithm.

• Prostate segmentation
algorithm was tested in a
clinical use context
• i.e. as a semiautomatic
algorithm after correction by
trained clinicians.

• IS0 14971 – Medical devices
–Application of risk
management to medical
devices
• IEC 62304 – Medical device
software – Software life cycle
processes
• IEC 62366 – Medical
devices – Application of
usability engineering to
medical devices

• Tested in accordance with
verification and validation
processes and planning
• The testing results support
that all the system
requirements have met their
acceptance criteria and are
adequate for its intended use


Compatibility
with the
environment
and other
devices

Prostate gland Volume, PSA
density, ROIs within the
prostate, with for each ROI:
• Volume
• Average ADC value
• PI-RADS score
• Location

Prostate gland volume, PSA
density, ROIs within the
prostate, with for each ROI:
• Volume
• Average ADC value
• PI-RADS score
• Location

DICOM compatible data, type
of MRI scans: T2-weighted,
DWI, ADC, DCE


Demographic information on subjects (N=114)


Race
Dice Coefficient
Hausdorff Distance

comparing ground truth and the result of algorithms by race


comparing ground truth and the result of algorithms by age


Sites
University of Missouri Health Care

MR Scanner Manufacturer
SIEMENS, Siemens HealthCare GmbH

Purpose of AI
Prostate region semi auto-segmentation


Item
Proposed Device
Predicate Device
Remark

such as: CBV, CBF, etc. in order to analyze
functional blood flow information about a region of
interest (ROI) in brain.
 The uOmnispace.CT Heart application is
intended to segment heart and extract coronary
artery. It also provides analysis of vascular stenosis,
plaque and heart function.
 The uOmnispace.CT Calcium Scoring
application is intended to identify calcifications and
calculate the calcium score.
 The uOmnispace.CT Dynamic Analysis
application is intended to support visualization of the
CT datasets over time with the 3D/4D display
modes.
 The uOmnispace.CT Bone Structure
Analysis application is intended to provide
visualization and labels for the ribs and spine, and
support batch function for intervertebral disk.
 The uOmnispace.CT Liver Evaluation
application is intended to provide processing and
visualization for liver segmentation and vessel
extraction. It also provides a tool for the user to
perform liver separation and residual liver segments
evaluation.
 The uOmnispace.CT Dual Energy Analysis
is a post-processing software package that accepts
UIH CT images acquired using different tube
voltages and/or tube currents of the same anatomical
location. The uOmnispace.CT Dual Energy
application is intended to provide information on the
chemical composition of the scanned body materials
and/or contrast agents. Additionally, it enables

information about a region of interest (ROI) in the
brain.
 The CT Heart application is intended to
segment heart and extract coronary artery. It also
provides analysis of vascular stenosis, plaque and
heart function.
 The CT Calcium Scoring application is
intended to identify calcifications and calculate the
calcium score.
 The CT Dynamic Analysis application is
intended to support visualization of the CT datasets
over time with the 3D/4D display modes.
 The CT Bone Structure Analysis application
is intended to provide visualization and labels for the
ribs and spine, and support batch function for
intervertebral disk.
 The CT Liver Evaluation application is
intended to provide processing and visualization for
liver segmentation and vessel extraction. It also
provides a tool for the user to perform liver
separation and residual liver segments evaluation.


images to be generated at multiple energies within
the available spectrum.
 The uOmnispace.CT Cardiovascular
Combined Analysis is an image analysis software
package for evaluating contrast enhanced CT
images. The CT Cardiovascular Combined Analysis
is intended to analyze vascular and cardiac
structures.It can be used in the qualitative and
quantitative for the analysis of head-neck, abdomen,
multi-body part combined, TAVR (Transcatheter
Aortic Valve Replacement) CT data as input for the
planning of cardiovascular procedures.


Pulmonary lobes Segmentation
Yes
Yes
Same

Airway Tree Extraction and Editing
Yes
Yes
Same


Shanghai United Imaging H
ealthcare Co., Ltd.

Application
Function Name
Proposed Device
Predicate
Reference Device#5
Remark

uOmnisapce.CT
Device: i
Schema View's RAPID

uOmnispace.CT
Motion Correction
Yes
Yes
/
Same

Brain Perfusion
Arterial Detection
Yes
Yes
/
Same

Shanghai United Imaging Healthcare Co., Ltd.


Hyper Realistic Rendering
Yes
/
Yes
Same

Heart Chamber Segmentation
Yes
Yes
/
Same

Coronary Artery Extraction
Yes
Yes
/
Same

Functional Substantial
Equivalent
Note 3


Application
Function name
Proposed device
Predicate device:
Remark

Functional Substantially
Equivalent
Note 4


Functional Substantial Equivalent
Note 5

Functional Substantial Equivalent
Note 6


Shanghai Unite
d Imaging Healthcare Co., Ltd.

Applica
tion
Function name
Proposed device
Predicate device
Reference device#3
Reference
Remark

uOmnis
pace.CT
Phase Selection
Yes
Yes
/
/
Same

Vascular Territories
Yes
/
/
Yes
Functional


CNR(Contrast Noise Ratio) Image
Yes
Yes
Same

Base Material Images: Including
Water-Iodine, Water-Calcium,
Calcium-Iodine, Uric acid-Calcium,
Water-HAP, Liver-Fat Base
Material Pair image.

Functional Substantially
Equivalent
Note 8

Effective Atomic Number Images
 Component analysis of
kidney stones, uric acid stones or
non-uric acid stones
 Component analysis of
joint gout, uric acid gout or non-
uric acid gout

Functional Substantial
Equivalent
Note 9

Virtual Non contrast Images
Yes
Yes
Same


Save, Report, Print (True size
printing)

Functional Substantial
Equivalent
Note 10


Colon Segmentation and
Centerline Calculate

Polyps’ Quantitative
Calculation and Analysis


Vascular Measurement and
vascular stenosis analysis

Hyper Realistic Rendering
Yes
/
Yes
Same


Application
Function name
Proposed device
Predicate device:
Remark

Hyper Realistic Rendering Yes / Yes Same


Shanghai United Imaging
Healthcare Co., Ltd.

A
pplication
Function name
Proposed device
Predicate device:
Reference
Remark

u
Omnispace.CT
Vessel analysis：
Yes
Yes
/
Functional

C
ardiovascular
 Bone removal
Equivalent

C
ombined
 Vessel and centerlines
Note 11.


TAVR Evaluation ：
 Automatic Aortic
annulus location and manually
correction
 Automatic Coronary
ostia Location and manually
correction
 Multi-parameter
Calculation

Functional Substantial
Equivalent
Note 13


The average score of the proposed device
results is higher than 4 points.


Subgroup
Details of Each Subgroup
Sample Size

Table 8-2. Testing data subgroup information


Ethnicity
Average Score of All Test Dataset

Gender
Average Score of All Test Dataset


BMI (kg/m(2))
Average Score of All Test Dataset


Table 8-4. Validation type and acceptance criteria


Subgroup
Details of each subgroup
Sample Size

Table 8-5. Testing data subgroup information


Verify the consistency with ground truth

The mean landmark error between the
proposed device results and ground truth
is less than the threshold, 1 mm.

Subjective Scoring of doctors with U.S.
professional qualifications

The average score of the evaluation
criteria is higher than 2.

Table 8-7. Validation type and acceptance criteria


Information of data
Details of each subgroup
Sample size


All
Mean Landmark Error (mm)
Average Score

Age
Mean Landmark Error (mm)
Average Score

Gender
Mean Landmark Error (mm)
Average Score

Ethnicity
Mean Landmark Error (mm)
Average Score

US. Facility
Mean Landmark Error (mm)
Average Score


Characteristic
Subject Device
Predicate Device
Reference Device

Medical Image
Management and
Processing System

Review Panel
Radiology
Radiology
Radiology

Indications for use
Indications for use
AVIEW CAC

AVIEW CAC provides quantitative analysis of calcified plaques in the coronary arteries
using non-contrast/non-gated Chest CT scans. It enables the calculation of the Agatston
score for coronary artery calcification, segmenting and evaluating the right coronary artery
and left coronary artery. Also provide risk stratification based on calcium score, gender,
and age, offering percentile-based risk categories by established guidelines. Designed for
healthcare professionals, including radiologists and cardiologists, AVIEW CAC supports

tests, we conclude that the proposed device is substantially equivalent to the predicate devices.


storing, transferring, inquiring, and displaying CT data sets on-premises, facilitating
access through mobile devices and Chrome browsers. AVIEW CAC analyzes existing non-
contrast/non-gated Chest CT studies that include the heart of adult patients above the age
of 40. Also, the device's use should be limited to CT scans acquired on General Electric
(GE) or its subsidiaries (e.g., GE Healthcare) equipment. Use of the device with CT scans
from other manufacturers has not been validated or recommended.

AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets.
This software can be used to support the physician providing quantitative analysis of CT
images by image segmentation of sub-structures in the lung, lobe, airways, fissures
completeness, cardiac, density evaluation, and reporting tools. AVIEW is also used to
store, transfer, inquire and display CT data set on-premises and as a cloud environment to
allow users to connect by various environments such as mobile devices and Chrome
browsers. Converts the sharp kernel to soft kernel for quantitative analysis of segmenting
low attenuation areas of the lung. Characterizing nodules in the lung in a single study or
over the time course of several thoracic studies. Characterizations include nodule type,
location of the nodule, and measurements such as size (major axis, minor axis), estimated
effective diameter from the volume of the nodule, the volume of the nodule, Mean HU(the
average value of the CT pixel inside the nodule in HU), Minimum HU, Max HU,
mass(mass calculated from the CT pixel value), and volumetric measures(Solid major;
length of the longest diameter measure in 3D for a solid portion of the nodule, Solid 2nd
Major: The size of the longest diameter of the solid part, measured in sections
perpendicular to the Major axis of the solid portion of the nodule), VDT (Volume doubling
time), and Lung-RADS (classification proposed to aid with findings.). The system
automatically performs the measurement, allowing lung nodules and measurements to be
displayed and, integrate with FDA certified Mevis CAD (Computer aided detection)
(K043617). It also provides the Agatston score, volume score, and mass score by the whole
and each artery by segmenting four main arteries (right coronary artery, left main coronary,
left anterior descending, and left circumflex artery). Based on the calcium score provides
CAC risk based on age and gender. The device is indicated for adult patients only.

The HealthCCSng device is intended for use as a non-invasive post-processing
software to evaluate calcified plaques in the coronary arteries, which present a risk
for coronary artery disease. The software generates an estimated coronary artery
calcium detection category.
The HealthCCSng device analyzes existing non-cardiac-gated CT studies that
include the heart of adult patients above the age of 30. The device generates a three-
category output representing the estimated quantity of calcium detected together
with preview axial images of the detected calcium meant for informational
purposes only. The device output will be available to the radiologist as part of their
standard workflow. The HealthCCSng results are not intended to be used on a
stand-alone basis for risk attribution, clinical decision-making or otherwise
preclude clinical assessment of CT studies

The AVIEW CAC is a software product that can be installed on a PC. It shows images
taken with the interface from various storage devices using DICOM 3.0, the digital image
and communication standard in medicine. It also offers functions such as reading,
manipulation, analyzing, post-processing, saving, and sending images by using software
tools. And is intended for use as a quantitative analysis of CT scanning. It also provides a
calcium score by automatically analyzing coronary arteries from the segmented arteries.


Primary predicate device
BriefCase (K221240)

Manufacture
Heuron Co., Ltd.
Aidoc Medical, Ltd

Heuron ICH is radiological computer-aided
triage and notification software designed
for the analysis of non-contrast head CT
images in adults or transitional adolescents
aged 18 and older. This device is intended
to aid appropriately trained medical
specialists and hospital networks in
streamlining workflow by identifying and
communicating suspected positive findings
of Intracranial hemorrhage (ICH).

BriefCase is a radiological computer aided
triage and notification software indicated
for use in the analysis of nonenhanced head
CT images in adults or transitional
adolescents aged 18 and older. The device
is intended to assist hospital networks and
appropriately trained medical specialists in
workflow triage by flagging and
communication of suspected positive
findings of Intracranial hemorrhage (ICH)
pathologies.

A table comparing the key features of the subject and predicate devices is provided below.


Heuron ICH employs an artificial
intelligence algorithm to analyze non-
contrast CT images, flagging cases with
identified findings through a dedicated
application that operates in parallel with the
standard of care image interpretation
process. Users receive notifications for
cases with suspected findings, which
include compressed preview images
provided for informational purposes only
and are not intended for diagnostic use
beyond notification. Importantly, Heuron
ICH does not modify the original medical
images and is not intended to serve as a
diagnostic device.
The results generated by Heuron ICH are
intended to complement other patient
information and assist medical specialists in
prioritizing and triaging medical images.
Notified medical specialists are responsible
for viewing the full non-contrast CT images
in accordance with established standard of
care practices.

BriefCase uses an artificial intelligence
algorithm to analyze images and highlight
cases with detected findings on a standalone
desktop application in parallel to the
ongoing standard of care image
interpretation. The user is presented with
notification for cases with suspected
findings. Notifications include compressed
preview images that are meant for
informational purposes only and not
intended for diagnostic use beyond
notification. The device does not alter the
original medical image and is not intended
to be used as a diagnostic device.
The results of BriefCase are intended to be
used in conjunction with other patient
information and based on their professional
judgment, to assist with triage/prioritization
of medical images. Notified clinicians are
responsible for viewing full images per the
standard of care.

Hospital networks and appropriately
trained medical specialists

Compatible
input data
format and
modality

No, the device does not highlight or direct a
user’s attention to a specific location in the
image file.

Yes – PACS, Workstation, email, mobile
(Push, SMS)


Subgroup
AUC (95% CI)
Sensitivity (95% CI)
Specificity (95% CI)


Aquilion Serve (TSX-
307A/1) V1.3
Primary Predicate

JAK:
System, X-ray,
Tomography,
Computed

Aquilion Prime SP
(TSX-303B/8) V10.2
with AiCE-i
Reference Predicate


Subject Device
Primary Predicate
Reference Predicate

10 - 600 mA*
10 - 500 mA
(* with Option installed)

Max. 1,386 kHU/min
(16.5 kW)
Actual 1,008 kHU/min
(12.0 kW)

Focal spots sizes
– IEC 60336: 2005,
nominal:

Small: 0.9 mm x 0.8 mm
Large: 1.6 mm x 1.4 mm

Small: 0.9 mm x 0.7 mm
Large: 1.4 mm x 1.4 mm


Predicate device: ISchemaView Inc.
Rapid ASPECTS Software (K200760)

CINA-ASPECTS is a computer-aided
diagnosis (CADx) software device used
to assist the clinician in the assessment
and characterization of brain tissue
abnormalities using CT image data.
The Software automatically reorients
images, segments and analyzes
ASPECTS Regions of lnterest (ROIs).
CINA-ASPECTS extracts image data
for the ROI(s) to provide analysis and
computer analytics based on
morphological characteristics. The
imaging features are then synthesized
by an artificial intelligence algorithm
into a single ASPECT (Alberta Stroke
Program Early CT) Score.
CINA-ASPECTS is indicated for
evaluation of patients presenting for
diagnostic imaging workup with known
MCA or ICA occlusion, for evaluation of
extent of disease. Extent of disease
refers to the number of ASPECTS
regions affected which is reflected in
the total score. This device provides
information that may be useful in the
characterization of early ischemic

Rapid ASPECTS is a computer aided
diagnosis (CADx) software device used
to assist the clinician in the assessment
and characterization of brain tissue
abnormalities using CT image data.
The Software automatically registers
images and segments and analyzes
ASPECTS Regions of Interest (ROIs).
Rapid ASPECTS extracts image data
for the ROI(s) to provide analysis and
computer analytics based on
morphological characteristics. The
imaging features are then synthesized
by an artificial intelligence algorithm
into a single ASPECT (Alberta Stroke
Program Early CT) Score.
Rapid ASPECTS is indicated for
evaluation of patients presenting for
diagnostic imaging workup, or
evaluation of extent of disease. Extent
of disease refers to the number of
ASPECTS regions affected which is
reflected in the total score. This device
provides information that may be useful
in the characterization of early ischemic
brain tissue injury during image


significant noise within the
NCCT images that make the
scan technically inadequate.
Hemorrhagic Transformation,
Hematoma.

Primary Users
Neuroradiologist/Clinician
Neuroradiologist/Clinician

No; device does not mark, highlight, or
direct users’ attention to a specific
location in the original image

ASPECTS regions, highlighted by
algorithms.

Users must confirm ICA or MCA
occlusion prior to accessing CINA-
ASPECTS results

Users must confirm LVO prior to
accessing Rapid ASPECTS results


Elements of
Subject Device
Primary Predicate
Additional Predicate
Comparison

Device Name
RUS
Visible patient Suite
Synapse 3D Base Tools v6.6

Manufacturer
Hutom
Visible Patient, SAS
FUJIFILM Corporation

Classification
Class II
Class II
Class II
Same

RUS is medical imaging software that
is intended to provide trained medical
professionals with tools to aid them in
reading, interpreting, reporting, and
treatment planning for patients. RUS
accepts DICOM compliant medical
images acquired from iodine contrast-
enhanced abdomen CT.
This product is not intended for use
with or for the primary diagnostic
interpretation of Mammography

Visible Patient Suite is medical
imaging software that is intended to
provide trained medical professionals
with tools to aid them in reading,
interpreting, reporting, and treatment
planning for both pediatric and adult
patients. Visible Patient Suite accepts
DICOM compliant medical images
acquired from a variety of imaging
devices, including CT, MR.
This product is not intended for use
with or for the primary diagnostic

Synapse 3D Base Tools is medical
imaging software that is intended to
provide trained medical professionals
with tools to aid them in reading,
interpreting, reporting, and treatment
planning. Synapse 3D Base Tools
accepts DICOM compliant medical
images acquired from a variety of
imaging devices including, CT, MR,
CR, US, NM, PT, and XA, etc. This
product is not intended for use with
or for the primary diagnostic


-Imaging tools for CT images
including virtual endoscopic viewing
and dual energy image viewing.
-Imaging tools for MR images
including delayed enhancement
image viewing, diffusion-weighted
MRI image viewing.

Intended user
Trained professionals (including
Trained professionals (including
Trained medical professionals
Same

physicians, surgeons and technicians)
physicians, surgeons and technicians)

Where used
Hospital
Hospital
Hospital
Same

Type of input data
CT
CT, MR
CT, MR, CR, US, NM, PT, and XA,
Same

Pseudonymization (Patient name, ID)
information)
study list)


General image
data management
and
administration
tools

Hardware platform
Windows PC
Windows PC
Windows PC
Same


• Bolus Quality: absent or
inadequate bolus.
• Patient Motion: excessive
motion leading to artifacts
that make the scan technically
inadequate.
• Presence of hemorrhage

Software package which interfaces to a
PACS or allows viewing within the
application

Standard off-the-shelf Hardware: On-
Premises

Standard off-the-shelf Hardware: Hybrid (on-
premises/cloud)

Software
Traditional Coding for platform
Traditional Coding for platform

Rapid is a software package that
provides for the visualization and study
of changes of tissue in digital images
captured by CT and MRI. Rapid
provides viewing and quantification.
The base Platform provides common
services to the imaging modules

Computed Tomography (CT) via
DICOM Format

Magnetic Image Resonance (MRI) via
DICOM Format


Feature
Predicate device
Subject device
Comment

YSIO X.pree is a device
intended to visualize
anatomical structures by
converting an X-ray pattern
into a visible image.
YSIO X.pree enables
radiographic exposures of
the whole body and may be
used on pediatric, adult and
bariatric patients. It can also
be used for emergency
applications.
YSIO X.pree is not for
mammography
examinations.

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.

X-ray techniques
Radiography
Radiography
Same

Combined
Applications to
Reduce Exposure


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

Wall stand with fixed
detector and wall stand with
bucky

Live camera for patient
positioning and collimation

Similar
New Camera
Model, same
functionality

Different.
Changed to new
algorithm, Auto
Long-Leg/Full-
Spine collimation
added

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


Feature
Predicate device
Subject device
Comment

Same
The camera, used
for MULTIX
Impact, is now used
for YSIO X.pree
VA20

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

Same
The algorithm, used
in MULTIX Impact,
is also used for
YSIO X.pree VA20

Impact) – AI based Automatic Collimation


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

Table 9: Non-clinical performance testing


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


149 New Montgomery St, 4th Floor
San Francisco CA 94105

Email: kkoster@ceevra.com
Phone: 415-305-5326


Automated Radiological Image Processing Software


Updated Device:
Originally Cleared Device:

Ceevra Reveal 3+
Ceevra Reveal 3 (K222676)

Ceevra Reveal 3+ is intended as a medical imaging
system that allows the processing, review, analysis,
communication and media interchange of multi-
dimensional digital images acquired from CT or MR
imaging devices and that such processing may include
the generation of preliminary segmentations of normal
anatomy using software that employs machine learning
and other computer vision algorithms. It is also intended
as software for preoperative surgical planning, and as
software for the intraoperative display of the
aforementioned multi-dimensional digital images.
Ceevra Reveal 3+ is designed for use by health care
professionals and is intended to assist the clinician who
is responsible for making all final patient management
decisions.
The machine learning algorithms in use by Ceevra
Reveal 3+ are for use only for adult patients (22 and
over). Three-dimensional images for patients under the
age of 22 or of unknown age will be generated without
the use of any machine learning algorithms.

Ceevra Reveal 3 is intended as a medical imaging
system that allows the processing, review, analysis,
communication and media interchange of multi-
dimensional digital images acquired from CT or MR
imaging devices and that such processing may include
the generation of preliminary segmentations of normal
anatomy using software that employs machine learning
and other computer vision algorithms. It is also intended
as software for preoperative surgical planning, and as
software for the intraoperative display of the
aforementioned multi-dimensional digital images.
Ceevra Reveal 3 is designed for use by health care
professionals and is intended to assist the clinician who
is responsible for making all final patient management
decisions.
The machine learning algorithms in use by Ceevra
Reveal 3 are for use only for adult patients (22 and over).
Three-dimensional images for patients under the age of
22 or of unknown age will be generated without the use
of any machine learning algorithms.

Table 6.1: Comparison of Intended Use Statements


Feature/
Updated Device:
Originally Cleared Device:

Function
Ceevra Reveal 3+
Ceevra Reveal 3 (K222676)

Supported image Modalities
CT and MR
CT and MR

Intended users
Healthcare Professionals
Healthcare Professionals

Healthcare facilities such as
hospitals and clinics

Interactive manipulation and
3D visualization

3D images used intraoperatively for
real-time guidance, navigation or
otherwise integrated with surgical
instruments

Segmentation work performed by
Internal Operators
Internal Operators

Built-in features for end-user to
compare CT/MR to device output

Quantitative measurements
calculated by device

Volume of structure,
diameter of structure,
distance between two points

Software generates semi-automated
segmentations of abnormal anatomy

Software generates semi-automated
segmentations of certain normal
anatomy

Table 6.2: Comparison of Technological Characteristics


The data used in the device validation ensured

diversity in patient population and scanner manufacturers. Subgroup analysis was performed for patient

age, patient sex, and scanner manufacturers.

at the level of the scanning institution, namely, studies sourced from a specific institution were used for


Parameter
Rapid (K213165) – Primary Predicate
Rapid – Subject Device

Rapid is an image processing software package to be used
by trained professionals, including but not limited to
physicians and medical technicians. The software runs on
a standard off-the-shelf computer or a virtual platform,
such as VMware, and can be used to perform image
viewing, processing and analysis of images. Data and
images are acquired through DICOM compliant imaging
devices.
Rapid provides both viewing and analysis capabilities for
functional and dynamic imaging datasets acquired with CT
Perfusion (CTP), CT Angiography (CTA), and MRI
including a Diffusion Weighted MRI (DWI) Module and a
Dynamic Analysis Module (dynamic contrast-enhanced
imaging data for MRI and CT).
The CT analysis includes NCCT maps showing areas of
hypodense and hyperdense tissue.
The DWI Module is used to visualize local water diffusion
properties from the analysis of diffusion - weighted MRI
data.
The Dynamic Analysis Module is used for visualization
and analysis of dynamic imaging data, showing properties
of changes in contrast over time. This functionality
includes calculation of parameters related to tissue flow
(perfusion) and tissue blood volume.
Rapid CT-Perfusion and Rapid MR-Perfusion can be used by
physicians to aid in the selection of acute stroke patients (with
known occlusion of the intracranial internal carotid artery or
proximal middle cerebral artery)

Rapid is an image processing software package to be used
by trained professionals, including but not limited to
physicians (medical analysis and decision making) and
medical technicians (administrative case processing). The
software runs on a standard off-the-shelf computer or a
virtual platform, such as VMware, and can be used to
perform image viewing, processing, and analysis of
images. Data and images are acquired through DICOM
compliant imaging devices. Rapid is indicated for Adults
only.
Rapid provides both viewing and analysis capabilities for
functional and dynamic imaging datasets acquired with
CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm
CT Perfusion and MRI including a Diffusion Weighted
MRI (DWI) Module and a Dynamic Analysis Module
(dynamic contrast-enhanced imaging data for MRI,
CT, and C-arm CT).
Rapid C-arm CT Perfusion can be used to qualitatively
assess cerebral hemodynamics in the angiography suite.
The CT analysis includes NCCT maps showing areas of
hypodense and hyperdense tissue.
The DWI Module is used to visualize local water
diffusion properties from the analysis of diffusion -
weighted MRI data.
The Dynamic Analysis Module is used for visualization
and analysis of dynamic imaging data, showing properties
of changes in contrast over time. This functionality
includes calculation of parameters related to tissue flow

Table 1: Substantial Equivalence Comparison


(perfusion) and tissue blood volume.
Rapid CT Perfusion and Rapid MR Perfusion can be used
by physicians to aid in the selection of acute stroke
patients (with known occlusion of the intracranial internal
carotid artery or proximal middle cerebral artery).
Instructions for the use of contrast agents for this
indication can be found in Appendix A of the User’s
Manual. Additional information for safe and effective
drug use is available in the product-specific iodinated CT
and gadolinium-based MR contrast drug labeling.
In addition to the Rapid imaging criteria, patients must
meet the clinical requirements for thrombectomy, as
assessed by the physician, and have none of the following
contraindications or exclusions:
• Bolus Quality: absent or inadequate bolus.
• Patient Motion: excessive motion leading to artifacts
that make the scan technically inadequate.
• Presence of hemorrhage.
• C-Arm CTP is not used in the Rapid Thrombectomy
indication for patient selection criteria, other
modalities should be consulted.
Caution
CBV and CBT are not absolute and CBT, CBV, MTT and
Tmax are supported for qualitative interpretation of the
perfusion maps only.

Software package which interfaces to a PACS or allows
viewing within the application

Standard off-the-shelf Hardware: On-Premises or Cloud
Hybrid

Software
Mixed Traditional and AI/ML
Same


Rapid is a software package that provides for the
visualization and study of changes of tissue in digital
images captured by CT and MRI. Rapid provides
viewing and quantification. C-Arm CT is for
qualitative assessment only.

Computed Tomography (CT) via DICOM Format

C-Arm CT via DICOM Format (not supported in
predicate)

Magnetic Image Resonance (MRI) via DICOM Format

MRI
Diffusion Weighted Image (DWI)
Supported

Dynamic Analysis tissue flow (perfusion) and tissue blood
volume

CTA-large vessel density analysis
Supported

C-arm CT Perfusion (C-arm CTP) – Not Supported

Diffusion MRI
Isotropic DWI (isoDWI)
Supported

Trace of diffusion tensor (Trace)
Supported

Fractional Anisotropy (FA) and color FA
Supported

Tissue residue function time to peak (Tmax)

CBV – Not Supported
Supported via qualitative analysis

MTT – Not Supported
Supported via qualitative analysis

Tmax – Not Supported
Supported via qualitative analysis

Arterial input function (AIF)Venous output function
(VOF)


Region of interest (ROI) and Volumetry
Supported

Volumetric comparison between 2 ROIs
Supported

Export perfusion and diffusion files to PACS and DICOM
file systems

Acquire, transmit, process, and store medical images

Selection of Patients meeting criteria for thrombectomy


The feature is not supported for the subject device

The feature is newly supported for Siemens CT Scanners and newly introduced
within the subject device submission

The feature remains unchanged from that within the predicate device. The
relevant modification was already present within the predicate device.

This feature is modified from the predicate / reference devices

This feature is currently supported by other cleared Siemens CT systems or
cleared Siemens stand-alone software applications. This feature will be
supported for the subject device with software version SOMARIS/10 syngo CT
VB10 and is substantially equivalent compared to the cleared version of the
primary/reference predicate device.


Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10

Whole body Computed Tomography
(CT) Scanner System

Environment of Use
Professional Healthcare Facility
Professional Healthcare Facility

Stellar
based on UFC (Ultra Fast Ceramic)

go.Up with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40.


+/- 30°
-30° to +28° with
optional 307 kg


Vector (1250
mm),
Vario 1 (1600
mm),
Vario RT (1600
mm)
with table
extension

Vario 1 (1600
mm),
Vario 2 (2000
mm),
Vario RT (1600
mm)
with table
extension

1680 mm with
table extension
2080 mm with
table extension

Max. 1600 mm
with patient
table extension
Max. 2000 mm
with patient
table extension

Spectral filtration
Tin Filter
Tin Filter

option for
patient
positioning with
3D Camera:
• gantry
mounted,
modified
design

option for
patient
positioning with
3D Camera:
• ceiling
mounted,
modified
design
• gantry
mounted,
modified
design


go.Top with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40.


+/- 30°
-30° to +28° with optional 307 kg
patient table

Vario 1 (1600 mm)
Vario 2 (2000 mm)
Vario RT (1600 mm)
with table extension


go.Open Pro with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40.


+/- 30
-30° to +25° with optional 307 kg
patient table

Vario 2 (2000 mm)
Vario RT (1600 mm)
with table extension

1680 mm with table extension
2080 mm with table extension

Max. 1600 mm with patient table
extension
Max. 2000 mm with patient table
extension


Subject device
SOMATOM X. Platform
with SOMARIS/10 syngo CT VB10

Whole body Computed Tomography
(CT) Scanner System

with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40 (K211373).


Vario RT (1600
mm)
Vitus (2000 mm)
Vario 2 (2000
mm)

Vario RT (1600
mm)
Vitus (2000 mm)
Vario 2.D (2000
mm)

Regular
installation
(Vario RT, Vario 2
and Vitus):
474 mm
Installation
option with
extended
distance (Vitus):
674 mm (474
mm + 200 mm)


x-ray foot switch
Option to trigger hands-free scanning
Option to trigger hands-free scanning

Table foot switch
Option for table patient movement
Option for table patient movement

Option for patient table movements,
including an electrical connection for
the tablet dock which allows charging
the tablet when mounted.

Option for mounting of the tablet on
the patient table.

Patient observation camera*
integrated on gantry front
*in syngo CT VB10 the patient
observation camera is renamed as
CARE 2D camera

Patient observation camera
integrated on gantry front


Software property
Subject device
Primary predicate device

SOMATOM go.Now
SOMATOM go.Up
SOMATOM go.All
SOMATOM go.Top
SOMATOM go.Sim
SOMATOM go.Open Pro
SOMATOM X.cite
SOMATOM X.ceed
with SOMARIS/10 syngo CT VB10

with SOMARIS/10 syngo CT VB10
with SOMARIS/10 syngo CT VA40

• Protocol supporting contrast
bolus-triggered data acquisition
• Contrast media protocols
(including coronary CTA)
• Pediatric Protocols
• Flex Dose Profile
• Turbo Flash Spiral
• Dual Energy acquisition
(TwinBeam DE and TwinSpiral
DE)
• Dynamic imaging (Flex 4D Spiral)
• Protocols supporting CT
Intervention (scan modes: i-
sequence, i-spiral, i-Fluoro)
• Protocols supporting Cardiac
Scanning
• Protocols for DirectBreathhold

Recon&GO:
- Spectral Recon (Dual Energy
Reconstruction from photon-
counting data) / including Virtual
Unenhanced, Monoenergetic plus
- Inline Results DE SPP (Spectral
Post-Processing with photon-
counting image data)
- Inline Anatomical ranges
(Parallel/Radial) incl. Virtual
Unenhanced, Monoenergetic plus
- Inline Spine and Rib Ranges
- Inline table and bone removal

Image viewing
CT View&GO offers:
CT View&GO offers:


- basic post-processing viewer (CT
View&GO)
- 2D and 3D (MPR, VRT, MIP and
minIP)
- Evaluation tools, Filming, Printing
- Interactive Spectral Imaging (ISI)
- Basic visualization tools: Endo
View
- Basic manipulation tools: DE ROI,
ROI HU, Average

• Recon&GO Inline Results
Software interface to post-
processing algorithms which are
unmodified when loaded onto the
CT scanners and 510(k) cleared as
medical devices in their own right.
• software interfaces for post-
processing functionalities to
provide advanced visualization
tools to prepare and process
medical images for diagnostic
purpose.
Note: The clearance of standalone
Advanced Visualization Application
software is mandatory precondition.
These advanced visualization tools
are designed to support the
technician & physician in the
qualitative and quantitative
measurement & analysis of clinical
data acquired and reconstructed by


Computed Tomography scanners.
Additional information regarding
the points of interface and inputs
for this feature is provided in
Section 16.

• FAST technologies
• CARE technologies
• GO technologies

ADMIRE*
SAFIRE
iMAR
*supported in SOMATOM go.All,
SOMATOM go.Top, SOMATOM
go.Sim, SOMATOM go.Open Pro,
SOMATOM X.cite and SOMATOM
X.ceed

ADMIRE*
SAFIRE
iMAR
*supported in SOMATOM
go.All,SOMATOM go.Top,
SOMATOM X.cite and SOMATOM
X.ceed

256 x 256 pixels
512 x 512 pixels
768 x 768 pixels
1024 x 1024 pixels (Precision
Matrix)


(including relative electron density
and relative mass density)

Respiratory Motion Management
support breath hold triggered spiral
scans with manual breath hold
triggered examinations.
Direct Breathold: externally
triggered workflow to start a spiral
scan by receiving a trigger signal
from an external gating device.
*Note: Direct Breathhold is not
available for SOMATOM go.Now


Feature/Non-clinical
Bench Testing performed

FAST 3D Camera /
FAST Integrated
Workflow

The bench test evaluates and compares the accuracy of the three sub-
features FAST Isocentering, FAST Range, and FAST Direction to the
accuracy of the predicate device with syngo CT VA40 using the old
camera hardware and the then only available ceiling mount.
The objectives of the bench test are to demonstrate that the FAST 3D
Camera feature of the subject device with SOMARIS/10 syngo CT VB10,
where the algorithms have been optimized for a new camera hardware
in two mounting positions, achieves comparable results as the predicate
device with syngo CT VA40.
The FAST Isocentering accuracy of the subject device with syngo CT VB10
is comparable to the predicate device with syngo CT VA40, regardless of
the camera mounting position.
For the FAST Range feature, the detection accuracy of all body region
boundaries is comparable between the subject device with syngo CT
VB10 and predicate device with syngo CT VA40. In the gantry mounting
position, the legs are often occluded by the torso when the patient is
lying head-first on the table. This is not a severe limitation, as leg
examinations are usually performed feet-first.
The FAST Direction pose detection results are of comparable accuracy for
subject and predicate device, regardless of the camera mounting
position.
Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy to
the SOMARIS/10 syngo CT VA40 predicate for the new FAST 3D Camera
hardware, also in the new gantry position.

Table 10: Non-clinical performance testing (bench testing).


A CT system with extended distance between CT gantry and patient table
base plus a mobile C-arm system were combined to evaluate the
technical feasibility and possible limitations of this combination.
The range of possible movement for the mobile C-arm in different
positions between CT gantry and patient table was tested and
documented by measurement of angles.
Based on the test results it can be concluded that a CT scanner, equipped
with a Multi-Purpose (Vitus) Patient Table, which is installed with
enhanced distance (674 mm) to the CT gantry and offers the iCT mode
functionality, provides sufficient freedom of movement for a mobile C-
arm X-ray system to be used for clinical routine without any significant
limitations for the myNeedle Lasers or FAST 3D Camera.

The test results showed that using the Direct Breathhold functionality, a
spiral scan can automatically be triggered from an external respiratory
gating device. The actual scan remains unchanged, and the object is
correctly depicted in the resulting image.

The bench tests evaluate the performance of ZeeFree reconstruction.
The objectives of the tests are to demonstrate:
• that the number of artefacts which can be attributed to a stack
misalignment (e.g. discontinuities in vessel structures,
anatomical steps at air-soft-tissue interfaces, doubling of vessel
or other anatomy) and which are often caused by incomplete
patient breath-hold can be reduced in a “Cardiac Stack Artefact
Correction” (SAC) reconstruction compared to the standard
reconstruction with otherwise matching reconstruction
parameters.
• that no artefacts are introduced by a SAC reconstruction.
The test results show:
• If misalignment artefacts are identified in non-corrected
standard ECG-gated reconstructed sequence or spiral images,
the feature “Cardiac Stack Artefact Correction” (SAC, marketing
name: ZeeFree) enables optional stack artefact corrected
images, which reduce the number of alignment artefacts.
• The SAC reconstruction does not introduce new artefacts, which
were previously not present in the non-corrected standard
reconstruction.
• The SAC reconstruction does realize equivalent image quality in
quantitative standard physics phantom-based measurements
(ACR, Gammex phantom) in terms of noise, homogeneity, high-
contrast resolution, slice thickness and CNR compared to a non-
corrected standard reconstruction.


• The SAC reconstruction does realize equivalent image quality in
quantitative and qualitative phantom-based measurements with
respect to metal objects compared to a non-corrected standard
reconstruction.
• The SAC algorithm can be successfully applied to phantom data if
derived from a suitable motion phantom demonstrating its
correct technical function on the tested device.
• The SAC algorithm is independent from the physical detector
width of the acquired data

myNeedle Guide
(with myNeedle
Detection)

Tests were performed to ensure clinical usability of the myNeedle Guide
needle detection algorithm. Two individual tests were performed. The
accuracy of the automatic needle detection algorithm was tested. The
reduction of necessary user interactions for navigating to a needle-
oriented view with and without the support of the automatic needle
detection algorithm was analyzed.
It has been shown that the algorithm was able to consistently detect
needle-tips over a wide variety of scans in 90.76% of cases.
Further, the results of this bench test clearly show that the auto needle
detection functionality reduces the number of interactions steps needed
to generate a needle-aligned view in the CT Intervention SW.
With successful AI-based needle tip detection, no user interaction is
needed to achieve needle-aligned view during needle progression.
Additional manual adjustment (fine tuning) of the needle-aligned view is
always possible.


Digital Imaging and
Communications in Medicine
(DICOM) Set

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

Table 11: Recognized Consensus Standards.


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

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

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

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

Medical devices - Applications
of risk management to
medical devices

Medical devices - Application
of risk management to
medical devices

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


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

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

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

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

62366-1 Edition 1.1
2020-06
CONSOLIDATED
VERSION

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

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

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

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

Medical electrical equipment
- Part 2-28: Particular


requirements for the basic
safety and essential
performance of X-ray tube
assemblies for medical
diagnosis

62563-1 Edition 1.2
2021-07
CONSOLIDATED
VERSION

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


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

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

Declaration of
conformance to FDA
recognized consensus
standards.

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

General consensus
standards not currently
recognized by FDA.

Table 12: General Use Consensus Standards.


The feature is newly supported for Siemens CT Scanners and the subject device

This feature is a modified form of a feature cleared within the predicate devices

This feature is currently supported by other cleared Siemens CT systems or
cleared Siemens stand-alone software applications.


SOMATOM Force
SOMARIS/7 syngo CT VB30
(K230421)

SOMARIS/10 syngo CT
SOMARIS/10 syngo CT
SOMARIS/7 syngo CT VB30

Direct Conversion
with “Quantum
Technology”

70, 90, 100, 120, 140,
150
(150 kV only available
on the smaller tube-
detector system (B
system) and only in
combination with the
additional Sn filter, 0.7
mm)


(for both tubes)
(for both tubes)
(for both tubes)

Maximum
temporal
resolution in ECG
gated or
triggered
examination
(ms)

mono-segment, standard:
75
mono-segment, optional:
66
bi-segment, standard: 38
bi-segment, optional: 33

Maximum scan
speed at pitch
(mm/s at pitch x)

Max. Scan length
Vario 2.D: 2000
Vario 2.D: 2000
PHS5: 1953


PHS5: 227
MPT4: 227 or 307 (with
bariatric/trauma table top)

Regular installation
(Vario 2.D and Vitus):
474 mm
Installation option
with extended
distance (Vitus):
674 mm (474 mm +
200 mm)

Regular installation (PHS5
and MPT4):
400 mm

Tin Filter for both
tubes:
0.4 mm
additional Tin Filter
for the smaller tube-
detector system (B
system) only:
0.7 mm

option for patient
positioning with 3D
Camera
ceiling mounted,
modified design


SOMATOM Force
SOMARIS/7 syngo CT VB30
(K230421)

SOMARIS/10 syngo CT
SOMARIS/10 syngo CT
SOMARIS/7 syngo CT VB30

Option for mounting
of the tablet on the
patient table.

Option to move the
table during
myNeedle Guide
procedures in the
examination room.
electrical connection
for the tablet dock
which allows charging
the tablet when
mounted.

i-control:
option to operate some of
the CT functions including
patient table movement as
an alternative to the gantry
operating panel and the
input units at the console.

Laser in combination
with FAST
Isocentering visualize
coordinates for
patient isocenter
position;
myNeedle Laser
visualizes a planned
needle path for
interventions


Software property
Subject device
Primary predicate
Secondary predicate

NAEOTOM Alpha
NAEOTOM Alpha
SOMATOM Force

SOMARIS/10 syngo CT
SOMARIS/10 syngo CT
SOMARIS/7 syngo CT

• Contrast media
protocols (including
coronary CTA)
• Pediatric Protocols
• Flex Dose Profile
• Turbo Flash Spiral
• Dual Energy
acquisition
• Dynamic imaging
(Flex 4D Spiral)
• Protocols supporting
CT Intervention,
Cardiac Scanning,
Spectral imaging for
child examination,
Spectral imaging with
high resolution
• Protocols for
Quantum Imaging
modes:
- Quantum
- Quantumplus
- Quantum HD
(previously:
Quantum High
resolution)
- Quantum HD
Cardiac
(previously High
resolution Dual
Source Cardiac
modes). In
addition, a
spectral image
results from
dual source
96x0.2mm ultra
high-resolution
mode can
optionally be
obtained

• Contrast media
protocols (including
coronary CTA)
• Pediatric Protocols
• Flex Dose Profile
• Turbo Flash Spiral
• Dual Energy
acquisition
• Dynamic imaging
(Flex 4D Spiral)
• Protocols
supporting CT
Intervention,
Cardiac Scanning,
Spectral imaging for
child examination,
Spectral imaging
with high resolution
• Protocols for
Quantum Imaging
modes:
- Quantum
- Quantumplus
- Quantum High
resolution
- High resolution
Dual Source
Cardiac modes

• Contrast media
protocols (including
coronary CTA)
• Pediatric Protocols
• Turbo Flash Spiral
• Dual Source Dual
Energy protocols
• Adaptive 4D Spiral
• Protocols for
Radiation Therapy
Planning
• Dual Source Dual
Energy protocols for
Radiation Therapy
Planning
• Protocols for CT
intervention,
Cardiac Scanning


- Quantumpeak
(Quantumpeak
mode is
identical to the
Dual Source
Dual Energy
modes at
SOMATOM Dual
Source Scanners
in K230421

Recon&GO:
-Spectral Recon (Dual
Energy Reconstruction
from photon-counting
data) / including Virtual
Unenhanced,
Monoenergetic plus
-Inline Results DE SPP
(Spectral Post-
Processing with photon-
counting image data)
-Inline Anatomical
ranges (Parallel/Radial)
incl. Virtual
Unenhanced,
Monoenergetic plus
(already cleared with
the stand-alone medical
device syngo.via
(K191040)
-Inline Spine and Rib
Ranges (already cleared
with the stand-alone
medical device syngo.CT
Applications (syngo.CT
Bone Reading)
K220450))

Recon&GO:
-Spectral Recon (Dual
Energy Reconstruction
from photon-counting
data) / including Virtual
Unenhanced,
Monoenergetic plus
-Inline Results DE SPP
(Spectral Post-
Processing with
photon-counting image
data)

Advanced
reconstruction tools
supported:
The syngo acquisition
workplace provides
image reconstruction
and routine
postprocessing.


- Inline table and bone
removal (already
cleared with the stand-
alone medical device
syngo.CT Extended
Functionality (K221727))

CT View&GO offers:
- basic post-processing
viewer (CT View&GO)
- 2D and 3D (MPR, VRT,
MIP and minIP)
- Evaluation tools,
Filming, Printing
- Interactive Spectral
Imaging (ISI)
- Basic visualization
tools: Endoscopic View
- Basic manipulation
tools: DE ROI, ROI HU
Threshold, Average
- Automated table and
bone removal
(already cleared with
the stand-alone medical
device syngo.CT
Extended Functionality
(K221727))

syngo Viewing offers:
- 2D and 3D (MPR, VRT,
MIP and minIP)
- Evaluation tools,
Filming, Printing

• Recon&GO Inline
Results:
Software interface to
post-processing
algorithms which are
unmodified when
loaded onto the CT
scanners and 510(k)

syngo.via - Wide Range
of individual
applications, syngo.via
is a software solution
intended to be used for
viewing, manipulation,
communication, and
storage of medical


cleared as medical
devices in their own
right.
• software interfaces
for post-processing
functionalities to
provide advanced
visualization tools to
prepare and process
medical images for
diagnostic purpose.
Note: The clearance of
standalone Advanced
Visualization Application
software is mandatory
precondition.
These advanced
visualization tools are
designed to support the
technician & physician
in the qualitative and
quantitative
measurement & analysis
of clinical data acquired
and reconstructed by
Computed Tomography
scanners. Additional
information regarding
the points of interface
and inputs for this
feature is provided in
Section 16.

images. It can be used
as a standalone device
or together with a
variety of cleared and
unmodified syngo
based software
options.

Cybersecurity
IT Hardening
IT Hardening
IT Hardening


Software property
Subject device
Primary predicate
Secondary predicate

NAEOTOM Alpha
NAEOTOM Alpha
SOMATOM Force

SOMARIS/10 syngo CT
SOMARIS/10 syngo CT
SOMARIS/7 syngo CT

• FAST technologies
• CARE technologies
• GO technologies
• CARE keV

myExam
Companion –
myExam
Compass/myExam
Cockpit

• myExam Compass
collects information
about the current
patient to dynamically
adapt the scan
parameters or exchange
recon jobs according to
the patient's
characteristics
• myExam Cockpit
option of displaying,
modifying, creating, and
deleting Clinical
Decision Trees (CDTs).
myExam Compass
functionality offers the
possibility to
activate/deactivate
diagnostic scan ranges,
Bolus Tracking and Test
Bolus ranges. myExam
Cockpit allows to define
these new settings.

Scan&GO
With software version
syngo CT VB10, the
previously stand-alone
Scan&GO software
functionality is fully
incorporated into the
subject device CT
scanner system. The


Reconstruction
Options for
Cardiac Imaging

• Standard
(renamed from
“TrueStack ‘off’” on the
primary predicate
device)
• TrueStack
(renamed from
“TrueStack ‘on’” on the
primary predicate
device)
• ZeeFree
allows the
reconstruction of
ECG-gated spiral or
ECG-triggered
sequence data in a
cardiac cycle-to-
cycle border aligned
fashion

Precision Matrix
resolution
support image matrix
sizes of:
512 x 512 pixels
768 x 768 pixels
1024 x 1024 pixels


• acquisition, storage,
and reconstruction
of projection raw
data of different
energy thresholds
(T1, T2, T3 and T4)
• projection raw data
of the three higher
energy thresholds
(T2, T3, and T3) can
be reconstructed by
offline
reconstruction tools
or on the CT system

• acquisition, storage,
and reconstruction
of projection raw
data of different
energy thresholds
(T1, T2, T3 and T4)
• projection raw data
of the three higher
energy thresholds
(T2, T3, and T3) are
reconstructed by
offline
reconstruction
tools.

• plan the needle path
and perform control
scans (i-Sequence, i-
Spiral, i-Fluoro)
• myNeedle Detection
algorithm
(modification of the
myNeedle Guide 3D
software)

• plan the needle
path and perform
control scans (i-
Sequence, i-Spiral, i-
Fluoro)

FAST 3D Camera
with FAST
Integrated
Workflow

FAST Integrated
Workflow including the
sub-features FAST
Range, FAST
Isocentering and FAST
Direction
FAST Range, FAST
Isocentering and FAST
Direction algorithms
optimized with data


Software property
Subject device
Primary predicate
Secondary predicate

NAEOTOM Alpha
NAEOTOM Alpha
SOMATOM Force

SOMARIS/10 syngo CT
SOMARIS/10 syngo CT
SOMARIS/7 syngo CT


Feature/Non-clinical
Bench Testing performed

FAST 3D Camera /
FAST Integrated
Workflow

The bench test evaluates and compares the accuracy of the three sub-
features FAST Isocentering, FAST Range, and FAST Direction to the
accuracy of the predicate device with syngo CT VA50 using the old
camera hardware and the then only available ceiling mount.
The objectives of the bench test are to demonstrate that the FAST 3D
Camera feature of the subject device with SOMARIS/10 syngo CT VB10,
where the algorithms have been optimized for a new camera hardware
in two mounting positions, achieves comparable results as the predicate
device with syngo CT VA50.
The FAST Isocentering accuracy of the subject device with syngo CT VB10
is comparable to the predicate device with syngo CT VA50, regardless of
the camera mounting position.
For the FAST Range feature, the detection accuracy of all body region
boundaries is comparable between the subject device with syngo CT
VB10 and predicate device with syngo CT VA50.
The FAST Direction pose detection results are of comparable accuracy for
subject and predicate device, regardless of the camera mounting
position.
Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy to
the SOMARIS/10 syngo CT VA50 predicate for the new FAST 3D Camera
hardware.

This document describes a hardware test in which a CT system with
extended distance between CT gantry and patient table base plus a
mobile C-arm system were combined to evaluate the technical feasibility
and possible limitations of this combination.
The range of possible movement for the mobile C-arm in different
positions between CT gantry and patient table was tested and
documented by measurement of angles.
Based on the test results it can be concluded that a CT scanner, equipped
with a Multi-Purpose (Vitus) Patient Table, which is installed with
enhanced distance (674 mm) to the CT gantry and offers the iCT mode
functionality, provides sufficient freedom of movement for a mobile C-
arm X-ray system to be used for clinical routine without any significant
limitations for my needle Laser or 3D Camera.

The bench tests evaluate the performance of ZeeFree reconstruction.
The objectives of the tests are to demonstrate:
• that the number of artefacts which can be attributed to a stack
misalignment (e.g. discontinuities in vessel structures,
anatomical steps at air-soft-tissue interfaces, doubling of vessel

Table 6: Non-clinical performance testing (bench testing).


or other anatomy) and which are often caused by incomplete
patient breath-hold can be reduced in a “Cardiac Stack Artefact
Correction” (SAC) reconstruction compared to the standard
reconstruction with otherwise matching reconstruction
parameters.
• that no artefacts are introduced by a SAC reconstruction.
The test results show:
• If misalignment artefacts are identified in non-corrected
standard ECG-gated reconstructed sequence or spiral images,
the feature “Cardiac Stack Artefact Correction” (SAC, marketing
name: ZeeFree) enables optional stack artefact corrected
images, which reduce the number of alignment artefacts.
• The SAC reconstruction does not introduce new artefacts, which
were previously not present in the non-corrected standard
reconstruction.
• The SAC reconstruction does realize equivalent image quality in
quantitative standard physics phantom-based measurements
(ACR, Gammex phantom) in terms of noise, homogeneity, high-
contrast resolution, slice thickness and CNR compared to a non-
corrected standard reconstruction.
• The SAC reconstruction does realize equivalent image quality in
quantitative and qualitative phantom-based measurements with
respect to metal objects compared to a non-corrected standard
reconstruction.
• The SAC algorithm can be successfully applied to phantom data if
derived from a suitable motion phantom demonstrating its
correct technical function on the tested device.
• The SAC algorithm is independent from the physical detector
width of the acquired data

myNeedle Guide
(with myNeedle
Detection)

Tests were performed to ensure clinical usability of the myNeedle Guide
needle detection algorithm. Two individual tests were performed. The
accuracy of the automatic needle detection algorithm was tested. The
reduction of necessary user interactions for navigating to a needle-
oriented view with and without the support of the automatic needle
detection algorithm was analyzed.
It has been shown that the algorithm was able to consistently detect
needle-tips over a wide variety of scans in 90.76% of cases.
Further, the results of this bench test clearly shows that the auto needle
detection functionality reduces the number of interactions steps needed
to generate a needle-aligned view in the CT Intervention SW. Zero user
interactions are required and a needle-aligned view is displayed right
away after a new scan, if auto needle detection is switched on in the SW


configuration. Therefore, the test is already passed if only a single user
interaction is necessary to achieve a needle-oriented view in the manual
workflow.

Tests were performed to demonstrate that:
• T3D reconstructions in Quantumpeak mode are possible with the
sharpest available kernels up to Qr89, Br98, etc.
• Quantumpeak scan mode allows reconstructions of
monoenergetic images at energy levels from 40 to 190 keV.
The evaluation has been performed based on phantom studies.
The results showed that:
• with T3D reconstructions from Quantumpeak scan modes, high
resolution images with sharp kernel up to Br98 are obtained. The
resolution is comparable to other Highresultra scan modes of the
NAEOTOM Alpha.
• Monoenergetic reconstructions from Quantumpeak scan modes
are free of artifacts. Measured CT values precisely match the
reference values.
• The accuracy of monoenergetic reconstructions in iodine and
calcium inserts at the NAEOTOM Alpha is comparable or better
than on the secondary predicate device SOMATOM Force.

Quantitative assessment in terms of image noise and a visual assessment
of the image quality in ECG gated acquisitions between different scan
modes is performed: standard acquisition mode with spectral and non-
spectral reconstruction, ultra-high resolution acquisition mode with non-
spectral reconstruction (120x0.2 mm and 96x0.2 mm) and spectral image
reconstruction (limited to 96x0.2 mm).
Based on the results it can be concluded that substantial equivalence in
image quality is achieved by the images derived from the spectral
capable cardiac acquisition mode 96x0.2mm for both, the high-
resolution UHR and the standard resolution spectral image cases,
compared to the single source spectral capable 120x0.2mm UHR scan
mode.

Tests were performed to evaluate the performance of HD FoV on
NAEOTOM Alpha.
For this purpose, the HU accuracy in the extended field of view region
was measured based on phantom studies. The phantom diameter
accuracy has been also evaluated.
Based on the results it can be concluded that HD FoV enables the
reconstruction of images while significantly improving the visualization


of anatomy in the regions outside the scan field of view of 50 cm. In the
phantom study, an HU value accuracy of about ± 40 HU was achieved
with skin-line accuracy of about ± 3 mm.


Digital Imaging and
Communications in
Medicine (DICOM) Set

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

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

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

Table 7: Recognized Consensus Standards.


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

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

Medical devices -
Applications of risk
management to
medical devices

Medical devices -
Application of risk
management to
medical devices

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

62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION

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


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

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

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

62366-1 Edition 1.1
2020-06
CONSOLIDATED
VERSION

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

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

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

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


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

62563-1 Edition 1.2
2021-07
CONSOLIDATED
VERSION

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


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

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

Declaration of
conformance to FDA
recognized consensus
standards.

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

General consensus
standards not currently
recognized by FDA.

Table 8: General Use Consensus Standards.


User Fees and Refunds for Premarket Notification Submissions (510(k)s 1

Table 9: FDA Guidance Document and Effective Date


Electronic Submission Template for Medical Device 510(k) Submissions

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

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

Content of Premarket Submissions for Device Software Functions

Off-The-Shelf Software Use in Medical Devices

Applying Human Factors and Usability Engineering to Medical Devices

Pediatric Information for X-ray Imaging Device Premarket Notifications

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

Electromagnetic Compatibility (EMC) of Medical Devices

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

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


The uMR Jupiter system is
indicated for use as a
magnetic resonance
diagnostic device (MRDD)
that produces sagittal,
transverse, coronal, and
oblique cross sectional
images, and spectroscopic
images, and that display
internal anatomical structure

The uMR Omega system is
indicated for use as a
magnetic resonance
diagnostic device (MRDD)
that produces sagittal,
transverse, coronal, and
oblique cross sectional
images, and spectroscopic
images, and that display
internal anatomical structure

Table 1 Comparison of Hardware configuration


and/or function of the head,
body and extremities.
These images and the
physical parameters derived
from the images when
interpreted by a trained
physician yield information
that may assist the diagnosis.
Contrast agents may be used
depending on the region of
interest of the scan.
The device is intended for
patients > 20 kg/44 lbs.

≤ 1.3 ppm @ 50cm DSV
≤ 0.45 ppm @ 45cm DSV
≤ 0.19 ppm @ 40cm DSV
≤ 0.08 ppm @ 30cm DSV
≤ 0.015 ppm @ 20cm DSV
≤ 0.0009 ppm @ 10cm DSV

≤ 2.30 ppm @ 50cm DSV
≤ 0.80 ppm @ 45cm DSV
≤ 0.38 ppm @ 40cm DSV
≤ 0.08 ppm @ 30cm DSV
≤ 0.02 ppm @ 20cm DSV
≤ 0.002 ppm @ 10cm DSV


Support
ECG/Respiratory/Pulse
signal triggering the scan


Table 2 Comparison of the Application Software Features


Shangh
ai United Imaging Healthcare Co., L
td.

Shanghai United Imaging Healthcare Co., Ltd.


The proposed device includes enhancements to the software that controls
Specific Absorption Rate (SAR) based on simulations for human at least 20kg.
Therefore, it is used for patient > 20 kg/44 lbs.
The difference did not raise new safety and effectiveness concerns.

The static field strength of the proposed device is different from the predicate
device, but the basic imaging characteristics are consistent.
The difference did not raise new safety and effectiveness concerns.

The patient-accessible bore dimension of the proposed device is smaller than that
of the predicate device, which satisfies the clinical applications. The difference
did not raise new safety and effectiveness concerns.

Magnet Homogeneity of the proposed device is better than that of the predicate
device. Magnet homogeneity contributes to image quality. The proposed device
with better magnet homogeneity is benefit for image quality.
The difference did not raise new safety and effectiveness concerns.

The max gradient amplitude of the proposed device is larger than that of the
predicate device. Peripheral nerve stimulation and cardiac stimulation was
controlled according to IEC 60601-2-33.
The difference did not raise new safety and effectiveness concerns.

The difference in the resonant frequencies of the proposed device and the
predicate device is due to the difference in field strength.
The difference did not raise new safety and effectiveness concerns.

The transmit channel number of the proposed device is more than that of the
predicate device. More transmit channels, better B1 uniformity. The local SAR
was monitored to ensure patients’ safety.
The difference did not raise new safety and effectiveness concerns.

The number of receive channels of proposed device is 96. The number of receive
channels of predicate device is 48 or 96. The number of receive channels of
proposed device is the same as one configuration of uMR Omega.
The difference did not raise new safety and effectiveness concerns.

The intended use of SuperFlex Small-24 is equivalent to previously cleared
SuperFlex Small-12. The difference between them is the number of channels of
the receiver coil.
The difference did not raise new safety and effectiveness concerns.

The intended use of Tx/Rx Head Coil -48 is equivalent to previously cleared
Head Coil -32. There are two differences between them. One is that Tx/Rx Head
Coil -48 can be used as a transmitter coil and SAR is controlled. The other one
is that the receiver channel number of Tx/Rx Head Coil -48 is more than that of
Head Coil -32.
The difference did not raise new safety and effectiveness concerns.

These coils were modified to adapt the frequency of the proposed device.
The difference did not raise new safety and effectiveness concerns.

The height of the patient table of the proposed device is higher than that of the
predicate device, which can satisfy clinical application.
The difference did not raise new safety and effectiveness concerns.


MASS is substantially equivalent to GRE and acquires three different types
(lower order SSFP_FID, SSFP_SE and higher order SSFP_FID) of echo images
and achieves T2 mapping image by an iteration and search method.
The difference did not raise new safety and effectiveness concerns.

CASS is substantially equivalent to BSSFP and acquires two different phase
cycling angle images and combines them by MIP operation to reduce dark band
artifacts.
The difference did not raise new safety and effectiveness concerns.

PASS is substantially equivalent to GRE and acquires two different type
(SSFP_FID and SSFP_SE) of echo image and combines them to achieve hybrid
contrast image.
The difference did not raise new safety and effectiveness concerns.

MoCap-Monitoring is a motion monitoring module which is periodic and is
inserted into a pulse sequence. It can realize real-time motion monitoring in
imaging scanning and provides an alert when motion occurs.
The difference did not raise new safety and effectiveness concerns.


Table 6 Distribution of volunteer dataset


SOMATOM go.All
Biograph Horizon
MI View &Go

Manufacturer:
Siemens Medical Solutions USA, Inc.


Resolution – Full Size
Axial FoV 1
Axial FoV 2

Transverse Resolution FWHM @ 1 cm
Pass
(cid:1095) 4.5 mm

Transverse Resolution FWHM @ 10 cm
Pass
(cid:1095) 5.0 mm

Transverse Resolution FWHM @ 20 cm
Pass
(cid:1095) 5.8 mm

Axial Resolution FWHM @ 1 cm
Pass
(cid:1095) 4.7 mm

Axial Resolution FWHM @ 10 cm
Pass
(cid:1095) 5.5 mm

Axial Resolution FWHM @ 20 cm
Pass
(cid:1095) 6.1 mm

Sensitivity @435 keV LLD
Pass
(cid:1096) 6.7 cps/kBq
(cid:1096) 12.0 cps/kBq

Scatter Fraction at peak NECR
Pass
(cid:1095)43%

Co-Registration Accuracy
Pass
(cid:1095)(cid:3)5 mm

Time of Flight Resolution at 5.3kBq/cc
Pass
(cid:1095) 274 ps

10mm sphere (Contrast / Background
Variability)

13mm sphere (Contrast / Background
Variability)

17mm sphere (Contrast / Background
Variability)

22mm sphere (Contrast / Background
Variability)

28mm sphere (Contrast / Background
Variability)

37mm sphere (Contrast / Background
Variability)


Super-conducting magnet, horizontal bore,
1.5 Tesla

Bore dimension
Circle shape with diameter 70cm
Circle shape with diameter 70cm

Rise Time
254μsec to 33mT/m
254μsec to 33mT/m

Duty Cycle
85% (Gating max), 10% at full power
85% (Gating max), 10% at full power


☐ Manufacturing Process
☐ Labeling
☐Technology

Summary is changed but there are no significant changes in technology, engineering and performance.


Receiver Coils
FlexFit Neuro Coil
FlexFit Neuro Coil

FlexFit Blanket Coil A,
FlexFit Blanket Coil B

Flex M Coil, Flex S Coil
Flex M Coil, Flex S Coil


Application Software
Going from V9.0A to V10.0A
See Table 7

Scan Tasks
Scan Tasks
Following function is updated.
See Table 7
See Table 7

Following positioning applications are added.

Following positioning application is updated.

Network Tools
Network Tools
Following Network Tools are added.
See Table 7
See Table 7

Protocol Enhancements
Following function is updated.
See Table 7

Following variation of Protocol Enhancements are added in Auto Table Centering.

- Chest, Breast, General Abdomen, Liver/Kidney, Pelvis, WholeBody

Following Protocol Enhancements are added.

2D RADAR sequence is added to the applicable sequence of DLR Rise.

3D sequences and 2D RADAR are added to the applicable sequence of IterativeRAPID.

Monitoring Tools
Monitoring Tools
Following function is added.


Application software is changed in V10.0A.


FUJIFILM Healthcare Corporation and clinical site

Subject type
Healthy volunte er and patients

positioning. The information on the data in the above evaluations is shown below.


Specification
Predicate Device
Proposed Device

Patient Population
Patients of all ages
Same


The Revolution Ascend User
Interface allows for
modifications of image
reconstruction settings (FBP,
ASiR-V, and other parameters)
based on users desired image
display and workflow set up.

- Standard
- Soft
- Detail
- Bone, Bone plus
- Chest
- Lung
- Ultra
- Edge, Edge plus

- Filtered back Projection
- ASiR-V
- Deep Learning Image
Reconstruction, DLIR
(K230807)


GE Healthcare (Tianjin) Company Limited
No. 266 Jingsan Road, Tianjin Airport Economic Area
Tianjin, P.R. China 300308

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

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

Magnetic Resonance Diagnostic Device per 21 CFR 892.1000

(1) SIGNATM Victor (K223439)
(2) SIGNATM Hero (K213668)

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


1.5T Superconducting Magnet with active
shielding

SIGNATM Champion uses the
same magnet as the
predicate SIGNATM Voyager,
with a modified enclosure
design.

Water cooled gradient coil with active
s hielding.

SIGNATM Champion uses the
same gradient subsystem as
the predicate SIGNATM
Voyager.


Transmit with integrated body coil and local
T/R coil.

SIGNATM Champion uses the
same integrated body coil as
the predicate SIGNATM
Voyager, but other
components in the transmit
chain are different. The
SIGNATM Champion uses the
In Scan Room transmit
architecture found in
Reference Device 1 (SIGNATM
Victor).

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

SIGNATM Champion uses the
same DPP architecture as
the predicate SIGNATM
Voyager.

Comprehensive suite of detachable coils for
imaging all anatomies

Coils used by SIGNATM
Champion are also used by
the predicate SIGNATM
Voyager and/or Reference
Device 1 (SIGNATM Victor).

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

Both SIGNATM Champion and
the predicate SIGNATM
Voyager are fully capable MR
systems with a wide range of
software features. SIGNATM
Champion includes some
new and enhanced features
such as AIR Recon DL and
Sonic DL that were not
included in the predicate
K192426 submission. The
SIGNATM Champion software
features are similar to those
found on Reference Device 2
(SIGNATM Hero).

Respiratory,
peripheral, and
cardiac gating.

Respiratory
peripheral and
cardiac gating with
wireless connection
option.

In addition to SIGNATM
Voyager’s gating solution,
SIGNATM Champion offers an
additional option to use
wireless connection.


GE Medical Systems SCS
Establishment Registration Number - 9611343
283 rue de la Miniere
78530 Buc, France

Peter Uhlir
Regulatory Affairs Program Manager
GE HealthCare
Tel: (+36) 70-436-9317
Email: peter.uhlir@ge.com

Elizabeth Mathew
Senior Regulatory Affairs Manager
GE HealthCare
Tel: 262-424-7774
Email: Elizabeth.Mathew@ge.com

Common/Usual Name:
System, X-Ray, Tomography, Computed

Primary Classification name:
Primary Regulation Number:
Primary Product Code:
Secondary Product Code:
Classification:

Computed tomography x-ray system
21 CFR 892.1750
JAK
QIH
Class II


Primary Predicate Device
Device name:
Common/Usual Name:
Manufacturer:
510(k) number:
Classification Name:
Regulation Number:
Product Code:
Classification:

CardIQ Suite
System, X-Ray, Tomography, Computed
GE Medical Systems SCS
K213725
Computed tomography x-ray system
21 CFR 892.1750
JAK
Class II

Reference Device
Device name:
Common/Usual Name
Manufacturer:
510(k) number:
Classification Name:
Regulation Number:
Product Code:
Classification:

CardIQ Xpress 2.0
System, X-Ray, Tomography, Computed
GE Medical Systems SCS
K073138
Computed tomography x-ray system
21 CFR 892.1750
JAK
Class II

510(k) Premarket Notification Submission-CardIQ Suite


Specification
Primary Predicate
Subject Device:
Comparison

Image Requirements:
* 120kVp
* Gated cardiac
acquisition
* DFOV - 24 cm - 26 cm
* Slice thickness ≤ 3mm
* Non-contrast

Image Requirements:
* 120kVp
* Gated cardiac
acquisition
* DFOV - 24 cm - 35 cm
* Slice thickness ≤ 3mm
* Non-contrast

Substantially equivalent.
The only modification in the subject
device comes from the DFOV limitation
that has been adjusted to be less
restrictive.

Segmentation
and labeling
calcific regions
in the
coronaries

Yes,
Automated using deep
learning algorithm

Manual
Segmentation
and labeling of
calcific regions

The software provides
the following labels for
the coronary arteries
according to regional
territories.
• LAD territory: Left
Main Artery (LMA),
Ramus Intermedius
Branch (RIB), Left
Anterior Descending
(LAD) and all Diagonal
branches.
• LCX territory: Left
Circumflex artery (LCX)
and all Obtuse marginal
branches.
• RCA territory: Right
Coronary Artery (RCA),
Posterior Descending
Artery (PDA) and