It is used by radiation
oncology department
to register
multi-modality images
and segment
(non-contrast) CT
images, to generate
needed information for
treatment planning,
treatment evaluation
and treatment
adaptation.

It is used by radiation oncology
department to register
multi-modality images and
segment (non-contrast) CT
images, to generate needed
information for treatment
planning, treatment evaluation
andtreatmentadaptation.

MIMsoftwareisusedbytrained
medical professionals as a tool
to aid in evaluation and
information management of
digital medical images. The
medical image modalities
include, but are not limited to,
CT, MRI, CR, DX, MG, US,
SPECT, PET and XA as
supported by ACR/NEMA
DICOM 3.0. MIM assists in the
followingindications:
Receive, transmit, store,

retrieve, display, print, and
process medical images
andDICOMobjects.
Create, display and print

reports from medical
images.

Velocityisasoftwarepackagethat
provides the physicians a means
for comparison of medical data
including imaging data that is
DICOMcompliant.
It allows the display, annotation,
volume operation, volume
rendering, registration, and
fusion of medical images as an
aid during use by diagnostic
radiology, oncology, radiation
therapy planning and other
medical specialties. Velocity is
notintendedformammography.

Workflow Box is a software
system designed to allow users
to route DICOM-compliant data
to and from automated
processing components.
Supported modalities include
CT,MR,RTSTRUCT.
Workflow Box includes
processing components for
automatically contouring
imaging data using deformable
image registration to support
atlas based contouring,
re-contouringofthesamepatient
and machine learning based
contouring.
Workflow Box is a data routing
andimage processing toolwhich
automaticallyappliescontoursto


ones, this device should
only be used for research
purposes.
Lossy compressed
mammographic images and
digitized film screen images
must not be reviewed for
primary image interpretations.
Images that are printed to film
must be printed using an
FDA-approved printer for the
diagnosis of digital
mammography images.
Mammographic images must be
viewed on a display system that
hasbeen clearedbythe FDAfor
the diagnosis of digital
mammography images. The
software is not to be used for
mammographyCAD.

Algorithm
DeepLearning
DeepLearning
Atlas-based
Atlas-based
Atlas Based contouring,


registrationbased
re-contouring, machine learning
basedcontouring

No Limitation on
scanner model,
DICOM 3.0
compliancerequired.

No Limitation on
scanner model,
DICOM 3.0 compliance
required.

No Limitation on scanner
model,
DICOM3.0compliancerequired.

No Limitation on TPS
model,DICOM
3.0 compliance
required.

No Limitation on TPS model,
DICOM
3.0compliancerequired.

Algorithm IntensityBased. IntensityBased. IntensityBased. IntensityBased. IntensityBased.

Auto rigid registration
and auto deformable
registration.

Auto rigid registration and
deformableregistration.

Auto rigid registration:
CT,MRI,PET
Auto deformable
registration: CT, MRI,
CBCT


No Limitation on
scanner model,
DICOM 3.0
compliancerequired.

No Limitation on
scanner model,
DICOM 3.0 compliance
required.

No Limitation on scanner
model,
DICOM3.0compliancerequired.


Predicate device: Cina software
(K200855)

Cina is a radiological computer
aided triage and notification
software indicated for use in the
analysis of (1) non-enhanced head
CT images and (2) CT angiography
of the head.
The device is intended to assist
hospital networks and trained
radiologists in workflow triage by
flagging and communicating
suspected positive findings of (1)
head CT images for Intracranial
Hemorrhage (ICH) and (2) CT
angiography of the head for large
vessel occlusion (LVO) of the
anterior circulation (distal ICA,
MCA-M1 or proximal MCA-M2).
Cina uses an artificial intelligence
algorithm to analyze images and
highlight cases with detected (1)
ICH or (2) LVO on a standalone
Web application in parallel to the
ongoing standard of care image
interpretation. The user is
presented with notifications for
cases with suspected ICH or LVO
findings.
Notifications include compressed
preview images that are meant for
informational purposes only, and
are not intended for diagnostic use
beyond notification. The device
does not alter the original medical
image, and it is not intended to be
used as a diagnostic device.
The results of Cina are intended to
be used in conjunction with other
patient information and based on
professional judgment to assist with
triage/prioritization of medical
images. Notified clinicians are
ultimately responsible for reviewing
full images per the standard of care.

Cina is a radiological computer aided
triage and notification software
indicated for use in the analysis of (1)
non-enhanced head CT images and
(2) CT angiographies of the head.
The device is intended to assist
hospital networks and trained
radiologists in workflow triage by
flagging and communicating
suspected positive findings of (1) head
CT images for Intracranial
Hemorrhage (ICH) and (2) CT
angiographies of the head for large
vessel occlusion (LVO).
Cina uses an artificial intelligence
algorithm to analyze images and
highlight cases with detected (1) ICH
or (2) LVO on a standalone Web
application in parallel to the ongoing
standard of care image interpretation.
The user is presented with
notifications for cases with suspected
ICH or LVO findings.
Notifications include compressed
preview images that are meant for
informational purposes only, and are
not intended for diagnostic use beyond
notification. The device does not alter
the original medical image, and it is
not intended to be used as a
diagnostic device.
The results of Cina are intended to be
used in conjunction with other patient
information and based on professional
judgment to assist with
triage/prioritization of medical images.
Notified clinicians are ultimately
responsible for reviewing full images
per the standard of care.


Non contrast CT scan of the head
or neck and CT angiogram images
of the brain

DICOM information about the
patient, study and current image

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

Artificial intelligence algorithm with
database of images

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

- LVO and ICH image processing
applications
- Cina Platform (worklist and Image
Viewer)


Prevalence
Cina - ICH triage application
Cina - LVO triage application

Table 1: PPV and NVP values for ICH and LVO image processing applications


Table 2: Time-to-notification for ICH and LVO image processing applications


syngo.CT Extended Functionality
(SOMARIS/8 VB70)

syngo.CT Extended Functionality
(SOMARIS/8 VB60)

The extension offers the possibility to
average on a pixel-by-pixel basis of two
different DICOM images. The “Average”
functionality can be used on individual
frames of the same series, or for frames
belonging to different series. The tool
saves a DICOM image as result series. This
extension does not introduce any new
clinical algorithms or features.

The user can perform a vascular
evaluation supporting the following main
functionalities:
• Measuring vessels
• Creating DICOM snapshots or result
series for documenting findings
• Working on images that are acquired
with CT or MR scanner systems
constituting one or more volumes of
vascular structures
Modification:
Improved quality of the bone removal
algorithm for the head & neck region.
Segmentation of the bones use a deep
learning algorithm instead of a
traditional image processing.

Display different representations of Dual
Energy data.
Modifications:
Support of circular and elliptic ROIs. In
VB70 version the measurement tool
supports all others ROIs (ROI Circle (incl.
elliptic) / ROI Freehand / ROI Auto
Contour / ROI Polygonal).

The oncology extension offers tools for
localization and evaluation of nodules.
Modifications:
With SOMARIS/8 VB70, the spectral
information displayed for circular ROIs
was extended to arbitrarily shaped ROIs.


Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 – 3.20

Medical Device Software –Software Life Cycle
Processes; 62304:2006 (1st Edition)/A1:2016

Medical devices – Application of risk
management to medical devices; 14971 Third
Edition 2019-12

Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2016

Medical devices - Symbols to be used with
medical device labels, labelling, and
information to be supplied - Part 1: General
requirements 15223-1:2016


Predicate Device
FDA Clearance Number
Product
Manufacturer

MR XA51A is substantially equivalent to the following predicate device:


Medical electrical equipment -
Part 1: General requirements for
basic safety and essential
performance (IEC 60601-
1:2005, MOD)

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

Medical devices - Application of
risk management to medical
devices

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

Medical device software -
Software life cycle processes

62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION


Automated Radiological Image Processing Software


Predicate Device
NeuroQuant manufactured by
CorTechs Labs
K170981

MRI:
Acquired using four different MRI
sequences either in 2D or 3D using
a specified protocol
(T1 pre-contrast, T1 post-contrast,
T2 and FLAIR)

MRI:
Neuroquant: 3D T1 pre-contrast scans
acquired with specified protocols
Lesionquant: 3D FLAIR scan acquired
with specified protocol

1.6 Comparison of Technological Characteristics with the Predicate Device


Semi-automatic and manual
segmentation of high-grade glioma

Semi-automatic and manual
segmentation of brain structures

Volumetric measurement of the
sub-components of high-grade
glioma

Automated measurement of brain
tissue volumes and structures and
lesions

- Provides volumetric
measurements of high-grade
brain glioma and
sub-components
- Includes segmented color
overlays of sub-components and
reports
- Automatically compares results
to prior scans when available

- Provides volumetric measurements
of brain structures and lesions
- Includes segmented color overlays
and morphometric reports
- Automatically compares results to
reference percentile data and to prior
scans when available


Table 5-1 Predicate Device – BoneMRI v1.2


BoneMRI is an
image processing
software that can be
used for image
enhancement in
MRI images. It can
be used to visualize
the bone structures
in MRI images with
enhanced contrast
with respect to the

Similar –
BoneMRI
v1.4 has an
expanded
indications for
use
including the
boney structures
of the lumbar
spine.


surrounding soft
tissue. It is to be
used in the pelvic
region, which
includes the boney
anatomy of the
sacrum, hip bones
and femoral heads.
Warning: BoneMRI
images are not
intended to replace
CT images and are
not to be used for
diagnosis or
monitoring of
(primary or
metastatic) tumors.

surrounding soft
tissue. It is to be
used in the pelvic
region, which
includes the bony
anatomy of the
sacrum, hip bones
and femoral heads;
and the lumbar
spine region, which
includes the bony
anatomy of the
vertebrae from L3 to
S1. BoneMRI is not
to be used for
diagnosis or
monitoring of
(primary or
metastatic) tumors.
Warning: BoneMRI
images are not
intended to replace
CT images

Target Population
Adults
Adults
The same


Device Nature
Software package
Software package
The same


MRIguidance
software
implements an
image
enhancement
algorithm using
convolutional
neural network.
Original images are
enhanced by
running them
through a cascade
of filter banks,
where thresholding
and scaling
operations are
applied. Separate
neural network-
based filters are
obtained to assign
a Hounsfield Unit
(HU) value to a
single volume
element, based on
intensity and
contextual
information. The
parameters of the
model were
obtained through
an algorithm
development
pipeline.

None – enhanced
images are viewed
on existing PACS
workstations


The software
operates on
DICOM files on the
file system,
enhances the
images, and stores
the enhanced
images on the file
system. The receipt
of original DICOM
image files and
delivery of
enhanced images
as DICOM files
depends on other
software systems.
Enhanced images
co-exist with the
original images.


Manufacturer
Quanta Computer Inc.
Zebra Medical Vision Ltd.
－

QOCA® image Smart CXR
Image Processing System is a
software as medical device
(SaMD) used, through artificial
intelligence/deep learning
technology, to analyze chest
X-ray images of adult patient,
and then identify cases with
suspected pneumothorax. This
product shall be used in
conjunction with Picture
Archiving and Communication
System (PACS) at the hospital.
This product will automatically
analyze the DICOM files

The Zebra Pneumothorax device
is a software workflow tool
designed to aid the clinical
assessment of adult Chest X-Ray
cases with features suggestive of
Pneumothorax in the medical
care environment.
HealthPNX analyzes cases using
an artificial intelligence
algorithm to identify suspected
findings.
It makes case-level output
available to a PACS/workstation
for worklist prioritization or
triage. HealthPNX is not

Similar
Both devices are
intended to aid in
worklist triage by
providing notification
of suspected
pneumothorax cases
using an artificial
intelligence algorithm.
They are not intended
to be used on a
stand-alone basis for
clinical
decision-making or
clinical diagnosis.

raise any new issue of substantial equivalence.


automatically pushed from
PACS, and then make a notation
next to the cases with suspected
pneumothorax. This product is
only used to remind radiologists
to prioritize reviewing cases with
suspected pneumothorax. Its
results cannot be used as a
substitute for a diagnosis by a
radiologist, nor can it be used on
a stand-alone basis for clinical
decision-making.

intended to direct attention to
specific portions or anomalies of
an image. Its results are not
intended to be used on a
stand-alone basis for clinical
decision-making nor is it
intended to rule out
Pneumothorax or otherwise
preclude clinical assessment of
X-Ray cases

Notification-only,
parallel workflow
tool

Identify patients
with prespecified
clinical condition

Clinical condition
Pheumothorax
Pheumothorax
Same

Independent of
standard of care
workflow


Aids prompt
identification of
cases with indicated
findings

Similar
The subject device will
be connected with
PACS and receives
patients’ chest X-ray
images. The results will
only be presented on
the workstation.
It will not raise any
new issues of safety or
efficacy.

The average performance time
is 4.94 seconds.

The average performance time
is 22.1 seconds.

Same
Both devices can
provide effective
triage.


The characteristics of the MIMIC dataset summarizes in below table:


Race and ethnicity
Taiwan population
2,947

The characteristics of the Taiwanese dataset summarizes in below table:


DTX Studio Clinic
3.0
(Subject Device)
(K221921)

Videa Caries Assist
Predicate Device
(Primary)
(K213795)

DTX Studio Clinic is a
computer assisted
detection (CADe)
device that analyses
intraoral radiographs
to identify and localize
dental findings, which
include caries,
calculus, periapical
radiolucency, root
canal filling
deficiency,
discrepancy at the

Videa Caries Assist is
a computer-assisted
detection (CADe)
device that analyzes
intraoral radiographs
to identify and localize
carious lesions. Videa
Caries Assist is
indicated for use by
board licensed dentists
for the concurrent
review of bitewing
(BW) radiographs

Second Opinion® is a
computer aided
detection ("CADe”)
software to identify
and mark regions in
relation to suspected
dental findings which
include Caries,
Discrepancy at the
margin of an existing
restoration, Calculus,
Periapical
radiolucency, Crown

Similar to Primary
Predicate, except for
some additional dental
findings and age of
patient population.
Patient population is
same as the Secondary
Predicate, but the
differences do not
raise a concern of
substantial

Table 1: Comparison of DTX Studio Clinic to Predicate Devices


margin of an existing
restoration and bone
loss. The DTX Studio
Clinic CADe
functionality is
indicated for use by
dentists for the
concurrent review of
bitewing and
periapical radiographs
of permanent teeth in
patients 15 years of
age or older.

acquired from adult
patients aged 22 years
or older.

(metal, including
zirconia & non-metal),
Filling (metal & non-
metal), Root canal,
Bridge and Implants. It
is designed to aid
dental health
professionals to review
bitewing and
periapical radiographs
of permanent teeth in
patients 12 years of
age or older as a
second reader.

equivalence as
demonstrated by
performance testing

Automated Detection
Output
Message indicating if
and how many dental
findings are detected
Set of togglable
bounding boxes
around suspected
dental findings

Automated Detection
Output
Message indicating if
and how many carious
lesions were detected.
Set of togglable
bounding boxes
around suspected
lesions

Automated Detection
Output
Bounding boxes

Dental Findings
Caries, periapical
radiolucency, root

Dental Findings
Caries, discrepancy at
the margin, calculus,

Similar to Predicate
Devices, additional
dental findings are


canal filling
deficiency,
discrepancy at the
margin of an existing
restoration, bone loss
and calculus

identified but the
differences do not
raise a concern of
substantial
equivalence as
demonstrated by
performance testing.

Patient population
Permanent teeth in
patients 15 years of
age or older

Patient population
Permanent teeth in
patients 12 years of
age or older

Similar to Predicate
Devices, the
differences do not
raise a concern of
substantial
equivalence as
demonstrated by
performance testing.

Same as Secondary
Predicate, the
differences do not
raise a concern of
substantial
equivalence as
demonstrated by
performance testing.

Intended user
Dentists
US license dentists
Dentists
Same


Specification
Subject Swoop® Portable MR
Predicate Swoop® Portable MR

Imaging System™
Imaging System™ (K201722/K221393)

The Swoop® Portable MR Imaging
System™ is a bedside magnetic
resonance imaging device for
producing images that display the
internal structure of the head where
full diagnostic examination is not
clinically practical. When interpreted
by a trained physician, these images
provide information that can be
useful in determining a diagnosis.

Adult and pediatric patients (≥ 0
years)

At the point of care in medical
facilities, including emergency rooms,
critical care units, hospital, or
rehabilitation rooms.

Energy Used and/or delivered:
Magnetic Resonance
Same

Physical Dimensions
835 mm x 630 mm x 652 mm
Same

Field Strength
63.3 mT permanent magnet
Same

Strength
X: 24 mT/m, Y: 23 mT/m, Z: 39 mT/m
24 mT/m

Rise Time
X: 2.1 ms, Y: 2.0 ms, Z: 3.8 ms
1.1 ms

Slew Rate
X: 24 T/m/s, Y: 22 T/m/s, Z: 21 T/m/s
22 T/m/s

Computer Display
Hyperfine-supplied tablet
Same

Inner Dimensions (mm)
205 mm x 240 mm
Same

The table below compares the subject device to the predicate.


Patient Weight Capacity
1.6kg-200 kg
2.6kg-200 kg

T1W
- T1-Standard
- T1-Gray/White Contrast

- Advanced Denoising (applies to
T1W, T2W, and FLAIR only)
- Image orientation transform
- Geometric distortion correction
- Receive coil intensity correction
- DICOM output


Test
Test Description
Applicable Standard(s)

Testing to verify image performance meets all
image quality criteria.

● NEMA MS 1-2008 (R2020)
● NEMA MS 3-2008 (R2020)
● NEMA MS 9-2008 (R2020)
● NEMA MS 12-2016
● American College of Radiology (ACR)
Phantom Test Guidance for Use of
the Large MRI Phantom for the ACR
MRI Accreditation Program
● American College of Radiology
standards for named sequences

Testing to verify electrical safety and EMC meet the
criteria.

requirements and applicable standards to support substantial equivalence.


Characterization of the specific absorption rate for
magnetic resonance imaging systems


Biocompatibility testing of patient-contacting
materials.

Cleaning and disinfection validation of patient-
contacting materials.

● FDA Guidance, “Reprocessing
Medical Devices in Health Care
Settings: Validation Methods and
Labeling”
● ISO 17664:2017
● ASTM F3208-17

Testing to verify cybersecurity controls and
management.

● Cybersecurity as recommended in
FDA guidance, “Content of
Premarket Submissions for
Management of Cybersecurity in
Medical Devices”

Verification testing to ensure the design outputs
meet the design input requirements.

● IEC 62304:2006
● FDA Guidance, “Guidance for the
Content of Premarket Submissions
for Software Contained in Medical
Devices”

Validation studies to ensure the device meets user
needs and performs as intended.


Medipixel, Inc.
Dooam Building 7F, 61, Yanghwa-ro, Mapo-gu, Seoul, Republic of Korea,
04037
Phone: +82-70-4699-0460
Fax: +82-50-7534-4375
E-mail: contact@medipixel.io

Seokjin Ham
Quality Management Representative of Medipixel, Inc.
Phone: +82-10-3664-3896
E-mail: harry.ham@medipixel.io
Hye-Ri Choi
RA Manager of Medipixel, Inc.
Phone: +82-70-4699-0460
E-mail: contact@medipixel.io

2) SUBMITTER’S INFORMATION [21 CFR 807.92(a)(1)]


Common/Usual Name
Cardiovascular Image Analysis Software

Automated Radiological Image Processing Software


Proprietary Name
QAngio XA (X-RAY VVA, K112807)

Common/Usual Name:
Radiological Image Processing Software

The identified predicate devices within this submission are shown as follows:


Device Name
MPXA-2000
QAngio XA (X-RAY VVA)

MPXA-2000 is indicated for use
in clinical settings where
validated and reproducible
quantified results are needed to
support the calculations in X-ray
angiographic images of the
coronary arteries, for use on
individual patients with coronary
artery disease (CAD). MPXA-
2000 is indicated for use in adult
patients only.
When the quantified results
provided by MPXA-2000 are
used in a clinical setting on X-
ray images of an individual
patient, they can be used to
support the clinical decisions
making for the diagnosis of the
patient or the evaluation of the
treatment applied. In this case,
the results are explicitly not to be
regarded as the sole, irrefutable
basis for clinical diagnosis, and
they are only intended for use by
the responsible clinicians.

X-RAY VVA is indicated for
use in clinical settings where
validated and reprodlucible
quantified results are needed to
support the calculations in X-
ray angiographic images of the
chambers of the and heart of
blood vessels, for use on
individual patients with
cardiovascular disease.
When the quantified results
provided by X-RAY VVA are
used in a clinical setting on X-
ray images of an individual
patient, they can be used to
support the clinical decisions
making for the diagnosis of the
patient or the evaluation of the
treatment applied. In this case,
the results are explicitly not to
be regarded as the sole,
irrefutable basis for clinical
diagnosis, and they are only
intended for use by the
responsible clinicians.

Intended Users
Cardiologists, Radiologists
Cardiologists, Radiologists


X-ray angiographic data in
DICOM format
(vendor-independent)

Manual editing of automatic results by
user

- Automatic calibration
based on isocenter
calibration factor in
DICOM file
- Other manual calibration
options (catheter
calibration)

- Automatic calibration
based on isocenter
calibration factor in
DICOM file
- Other manual calibration
options (catheter, marker
catheter, sphere, grid,
circle manual and line
calibration)

Automatic angiographic series
loading into the software from the
angiography equipment

 Zooming, panning
 Editing vessel
contours
 Angle, Length, Area,
Text Annotation

Automated 2D
arterial contour
segmentation

Optional Stent
analysis including
stent edges

Results for multiple
lesions and additional
user-defined ROIa)

Straight (main), ostial, and
bifurcation (side branch)

- % Diameter Stenosis
- Minimum lumen diameter
(MLD)
- Proximal and distal
diameters (at P- and D-
marker positions)
- ROIa) length
- Reference Diameter

- % Diameter Stenosis
- Minimum lumen diameter
(MLD)
- Proximal and distal
diameters (at P- and D-
marker positions)
- Lesion length
- Reference Diameter

Stent related statistics
No
- Length of stent and stent


edges
- MLD and its position
- In-stent Mean diameter

Automatically load and visualize ECG
data acquired from the DICOM file

Automatic EoD (End of Diastole)
phase detection in DICOM file based
on ECG.

Patient and study details,
calibration, annotation,
measurement, and analysis
details.

DICOM, BMP, JPEG, AVI and
the raw file format


(Predicate Device)
(Subject Device)
Substantial

Identical
Two new system configura-
tions have been added (MHS
and FHS). The tests carried
out and the risk analyses did
not reveal any particular risk
and validated the safety and
performance of the systems.

Similar
Because a new variant of En-
doNaut Software is intro-
duced, we introduce a new
naming convention to avoid
confusion between Endo-
Naut (Standalone) SW and
EndoNaut (Server) SW.
The naming convention is
detailed in Section 6 (Endo-
Naut System Device De-
scription).
No risk related to identifica-
tion between the two soft-
ware variants.

Manufacturer
Therenva SAS
Therenva SAS
Identical

Minor change
See below “Workstation
cart”

Identical
Therefore, substantially
equivalent.

EndoNaut (system):
3760262480046
EndoNaut SW
(Standalone):
3760262480022

EndoNaut (system) (Variant
1 = EndoNaut SW + Endo-
Naut Workstation):
3760262480046
EndoNaut System MHS:
3760262480084
EndoNaut System FHS:
3760262480077
EndoNaut (Standalone)SW:

Similar
No risk related to identifica-
tion between EndoNaut
medical device software/sys-
tem because different UDI-
DIs are allocated.
No risk related to identifica-
tion of EndoNaut System
because different UDI-DIs
are allocated.


3760262480022
EndoNaut (Server) SW:
3760262480053
EndoNaut Workstation
TS1CA2DS1-2:
3760262480039
EndoNaut Server Main Dis-
play SW: 3760262480091

New UDI-DI allocated to
EndoNaut SW medical de-
vice software variant, Endo-
Naut Server and its new ac-
cessory EndoNaut Server
Main Display
See also “Labelling” here af-
ter.

Similar
Adoption of a more tradi-
tional versioning system
more commonly applied by
software publishers to Endo-
Naut (Server) SW and Endo-
Naut Server Main Display
SW.
This change did not raise any
particular risk nor questions
of safety and effectiveness.

OWB (Primary product
code), LLZ (Secondary
product code)

Similar
OWB is used as Primary
product code in reference to
our original predicates but in
no case does EndoNaut pro-
duce x-rays. LLZ product
code is much more relevant.

Interventional Fluoroscopic
X-Ray System
Medical Image Management
a nd Processing System

Similar
Regulation name of second-
ary code added which is
more adequate for our ad-
vanced medical imaging de-
vice.

EndoNaut provides image
guidance by overlaying pre-
operative 3D vessel anatomy
onto live fluoroscopic im-
ages in order to assist in the

EndoNaut is an image fusion
software solution and com-
puterized navigational sys-
tem intended to assist X-ray
fluoroscopy-guided

Similar
Minor rewording of the In-
tended Use has been made to
facilitate the understanding
by the users and recipients of


(Predicate Device)
(Subject Device)
Substantial

positioning of the guide-
wires, catheters and other
endovascular devices.

procedures in the positioning
of surgical instruments and
endovascular devices.

the information but also to
make the "imaging input
data" consistent with the "in-
dications for use".
The general purpose of the
device and its function re-
main unchanged. The minor
rewording of the Intended
Use does not raise different
questions of safety and ef-
fectiveness.

EndoNaut is indicated for
the treatment of patients with
endovascular diseases and
who needs for example
(without this list being re-
strictive):
• endovascular aortic an-
eurysm repair (AAA
and TAA),
• angioplasty,
• stenting,
• embolization in iliac ar-
teries and correspond-
ing veins.
EndoNaut is indicated for
endovascular procedures in
the thorax, abdomen, pelvis
and lower limbs.

EndoNaut is an image fusion
software solution and com-
puterized navigational sys-
tem intended to assist X-ray
fluoroscopy-guided proce-
dures in the positioning of
surgical instruments and
endovascular devices.
EndoNaut is indicated for
use by Physicians for pa-
tients undergoing a fluoros-
copy X-ray guided proce-
dure in the chest, abdomen,
pelvis, neck and lower limbs,
such as aneurysm repair, ar-
tery/vein embolization, or
peripheral artery disease
treatment.
The information provided by
the software or system is in
no way intended to substitute
for, in whole or in part, the
surgeon's judgment and
analysis of the patient's con-
dition.
It is mandatory to check the
real-time anatomy with a
suitable imaging technique,
such as a contrast-enhanced
angiography, before deploy-
ing any invasive medical de-
vice.

Similar
Without being a X-ray de-
vice itself, as a matter of
principle, EndoNaut works
with fluoroscopic images to
produce image fusion. The
clear reference to X-ray
guided procedures aims at
providing more transpar-
ency.
Conditions and anatomical
locations are the same, just
written in a slightly different
way.


For EndoNaut System:
1 label in the “about” section
for the Medical Device Soft-
ware with the Trade Name
“EndoNaut Software”.
+
1 label on the workstation
with the Trade Name “Endo-
Naut” (for the whole Sys-
tem) and Workstation model
Number = TS1CA2DS1-2 +
unique Serial (production)
Number (for the whole Sys-
tem)
For EndoNaut Server:
1 label in the “about” section
for the Medical Device Soft-
ware server with the Trade
Name “EndoNaut Server”.

Identical (EndoNaut Soft-
ware and EndoNaut Work-
station)
New
The label on the new Soft-
ware variant follows the
same rule as for EndoNaut
Software.
As EndoNaut Server has no
user interface, if it is inte-
grated into a System, it will
keep its own labelling and
the labelling of the System
will be indicated on another
component of the System (a
client for example). This will
be done under the responsi-
bility of the integrator.

1 User Guide for EndoNaut
Software
1 User Guide for EndoNaut
Workstation +
1 addendum for informing
about the conditions govern-
ing the marketing of Endo-
Naut.

For EndoNaut System:
1 User Guide for EndoNaut
Software
1 User Guide for EndoNaut
Workstation +
1 addendum for informing
about the conditions govern-
ing the marketing of Endo-
Naut System.
For EndoNaut System
composed of EndoNaut
(Server) SW:
Integration manual, Com-
munication Protocol and
Developer Documentation.

Slight changes to EndoNaut
Standalone SW IFU only
following minor SW release.
No change to EndoNaut
Workstation IFU.
New
EndoNaut Server will be
provided with an integration
manual and Communication
Protocol.
EndoNaut Server Main Dis-
play SW will be provided
with an integration manual
and Developer Documenta-
tion.

DICOM Images
EndoNaut archive produced
with Therenva EndoSize
Planning Software.
C-Arm video stream

Similar
No new input data. No new
features.
Only the minimum hardware
and software requirements
differ slightly due to the


Minimum HW and SW re-
quirements
Clinical and performance re-
quirements (display of fu-
sion data, measurements,
motion detection, data re-
fresh, interoperability)

different deployment config-
urations.
The hardware compatibility
evaluation was carried out
during the design validation
of EndoNaut. The require-
ments for hardware were
also assessed during the clin-
ical protocol by collecting
data on hardware used by the
surgeon during the study.
The difference did not raise
any risk nor safety or perfor-
mance concerns.

Verified and validated fea-
tures (Image visualization,
measurements, fusion, regis-
tration, motion detection,
contrast detection)
Code and technical docu-
mentation

Similar
V&V's activities demon-
strate an equivalent level of
performance of the Endo-
Naut. For its server version,
due to the different architec-
ture, in some cases (recali-
bration in particular) we
even note a gain in terms of
execution speed. No unac-
ceptable risk for the security
of users, patients or IT has
been identified. No changes
were made to production
methods, code review and
associated documentation.
The outputs produced are
compliant with the stand-
ards.


(Predicate Device)
(Subject Device)
Substantial

The algorithms are carried
by the EndoNaut software
only.
Features which call ma-
chine-learning algorithms:
• Registration 3D/2D
• Motion detection
• Contrast injection
detection

The algorithms are carried
by the EndoNaut (standalone
and server) software only.
Features which call ma-
chine-learning algorithms:
• Registration 3D/2D
• Motion detection
• Contrast injection
detection

Similar
The algorithms have not
been changed. Only the way
they are implemented is dif-
ferent between the EndoNaut
Standalone Software and the
EndoNaut Server Software
(different architectures).
These implementation
changes do not change the
purpose of the algorithms
(they do what they did be-
fore). The validation carried
out raised no additional
questions for safety and ef-
fectiveness.

EndoNaut Software is the
class II medical device Soft-
ware which runs on a sepa-
rate interventional tools (im-
aging) workstation, the so-
named EndoNaut Work-
station which is the acces-
sory of the medical device
software.

EndoNaut system consists of
• a software part that car-
ries the medical features
and technologies that
are controlled
and
• a hardware part that en-
ables the medical device
to be used in accordance
with its intended pur-
pose. The hardware part
can be:
the EndoNaut
o
Workstation or
a computer meeting
o
the minimum Hard-
ware and Software
requirements for
EndoNaut
standalone SW or
EndoNaut Server.
The Hardware part
must be compliant
with the US regula-
tions.

Similar
Hardware and Software re-
quirements have been ad-
justed to EndoNaut Server
and are indicated in the Di-
rections for use as a prereq-
uisite. V&V activities didn’t
show any risk or failure. No
additional questions raised
for safety and effectiveness.

Identical
Therefore, substantially
equivalent.

EndoNaut requires the use of
EndoSize software
(K160376) to prepare patient

EndoNaut is interoperable
with the EndoSize software
(K160376) which is de-
signed to prepare patient

Similar as regards EndoSize
and New for EndoNaut
(Server) SW and EndoNaut
Server Main Display SW


data and perform preopera-
tive sizing.
Data imported from En-
doSize include 3D volume,
preoperative images, sizing
report (comments and meas-
urements), and snapshots
taken during sizing.

data and perform pre-opera-
tive sizing.
Data imported from En-
doSize include 3D volume,
preoperative images, sizing
report (comments and meas-
urements), and snapshots
taken during sizing.
EndoNaut Server does not
have a user interface. The
User interface is provided by
the clients.
External interface with cli-
ents is provided through a
communication protocol.

Some clarifications are
made.
Preoperative data is a man-
datory input for the use of AI
features, but it is not for the
PAD features.
Preoperative data include
pre-op CT images and sizing
report (in case of AI proce-
dures). The stent placement
strategy and sizing are usu-
ally performed pre-opera-
tively via the use of software
devices such as EndoSize.
Alternatives to EndoSize ex-
ist: other sizing or visualiza-
tion software. In such cases,
the data is then printed on
paper and used in the operat-
ing room as is.
The communication protocol
of EndoNaut (Server) SW
did not raise any risk nor
safety or performance con-
cerns.

Intra-operative fluoroscopy
or angiography, pre-opera-
tive CT scan image, pre-op-
erative 3D scanner volume
reconstruction (if any in case
of PAD procedures).
For AI procedures:
Before and during the inter-
vention, the user can access
information from pre-opera-
tive sizing report such as pre-
op CT images, measure-
ments, comments, snap-
shots and strategy.

Take and export snapshots.
Export panoramas in case of
PAD module.


Display 2D-3D fusion: 3D
volume pre-op overlay on
per-op 2D fluoroscopy.
Semi-automatic registration
(automatic or manual initial-
ization, automatic computa-
tion and manual validation).
Panorama creation: Acquisi-
tion and save of fluoroscopy
and angiography stage by
stage keeping the same C-
Arm orientation.
Display 2D-2D fusion: 2D
pre-op angiographic overlay
on per-op 2D fluoroscopy.
Synchronization between
current per-op 2D fluoros-
copy and 2D fluoroscopy
from recorded panorama.

Dynamic update on C-arm /
table / patient motion

Automatic motion detection
Registration: auto-
matic/manual initialization
and manual user validation.

Similar
Slight change for EndoNaut
(Standalone) SW:
The registration workflow is
modified to be more con-
sistent with clinical expecta-
tions.
The possibility to start again
a registration in automatic
mode is offered instead of
switching to semi-automatic
mode after a first try in auto-
matic mode. The way the
automatic mode works and
its performance, safety char-
acteristics are unchanged.
Without any change being
made to the automatic mode
(so no impact on safety or
performance, risks), users
have the possibility to adapt
the image received from the
CArm to display more bone
structures for example. Once
he relaunches the registra-
tion in automatic mode, it


(Predicate Device)
(Subject Device)
Substantial

may get better results at the
end of the registration pro-
cess.
For EndoNaut (Server) SW:
These features have been
transferred in the new soft-
ware architecture.
Final validation is always re-
quired. It is implemented at
the integrator's discretion via
the SYNC_CT_ACCEPT
command.
New risks due to the new
software architecture have
been addressed. New clinical
data were not necessary.
V&V activities were per-
formed and successful. No
additional questions raised
for safety and effectiveness.

Energy emitted or absorbed
No
No
Identical

Panel PC ACL OR-PC 27LP
Rated AC 100-240V, 1.5-0.6
A ~47 – 63 Hz
Monitor size: 27’’ LCD
Brightness: 300 cd/m2
Resolution: 1920 x 1080
Cooling Fanless (no mainte-
nance)

Workstation secondary dis-
play (touch screen)

One Touch monitor ELO
model 1502L,
rated AC 100-240 V
Input frequency: 50-60 Hz
Monitor size: 15.6’’ LCD
Native resolution:
Full HD : 1920 x 1080 ;
HD (WXGA) : 1366 x 768
Brightness:
Touch Pro 270 nits
Touch technology: PCAP

One Touch monitor ELO
model 1502L or 1519LM
rated AC 100-240 V
Input frequency: 50-60 Hz
Monitor size: 15.6’’ LCD
Native resolution:
Full HD : 1920 x 1080
(1502L);
HD (WXGA) : 1366 x 768
(1502L, 1519 LM)
Brightness:
1502L: Touch Pro 270 nits

Similar
Similar for ELO Touch
1502L, one reference added
(1519LM) which offers very
similar performance.
The brightness offered by
the ELO 1519LM ap-
proaches the full HD ELO
1502L.
The slight differences be-
tween the two models do not


raise risk, safety nor perfor-
mance concerns.

One mobile frame holder
ITD, including one isolating
transformer, rated AC 115V
/ 230V 50/60Hz 1240VA.

Minor change
Change of pro-cart Basic
frame: column raised by 16
cm for better visibility. No
change of pro-cart supplier.
No change of materials. In-
stability hazards have been
evaluated and tested.
No confusion possible be-
tween the old mobile frame
holder and the new mobile
frame holder because they
are different part reference.
No overbalance or hazards
that could jeopardize the
safety of the users and bene-
ficiaries and call into ques-
tion the performance
of the medical device could
be observed.

Height: 1740 mm
Width (footprint): 661 (640)
mm
Depth (footprint): 950 (660)
mm
Weight: 70 kg

Height: 1850 mm
Width (footprint): 661 (640)
mm
Depth (footprint): 950 (660)
mm
Weight: 72 kg

Similar
Minor dimensional and
weight changes do not result
in additional risks.

Digital video input: DVI-D
or DVI-I*
Video output: HDMI
Network: 10/100/1000 Mbps
Ethernet (RJ45)
USB interface USB 3.0
(x2)

Input voltage:
100 – 230 VAC / 50 – 60 Hz

Connection Box
Front cable RJ45
DVI front cable
USB 3.0 front cable
1m (x2)
Power supplies


(Predicate Device)
(Subject Device)
Substantial

Power supply extension IEC
C7-C14
Power supply extension jack
2.5mm 3m
IEC extension cable 1m
(red)
IEC extension cable 0.5m
(blue)
External power supply XP
POWER (for ELO TOUCH
1502L)
External power supply
BICKER (for ACL ORPC-
27LP) BET-1012M
Video cabling: DVI 5m
Other cables:
HDMI cable 1.5m
HDMI/DP adapter
USB 3.0 A/B 1m
USB 2.0 2m
Equipotential 1.5m

DICOM Standard parts 1-20
Applied
Applied
Identical

Conformity to IEC 60601-1
of EndoNaut workstation

Identical
IEC 60601-1 is not a FDA
recognized standard version
but is applied and included in
V&V protocol and results.

Conformity to ANSI AAMI
ES60601-1:2005/(R)2012
and A1:2012,
C1:2009/(R)2012 and
A2:2010/(R)2012 (Consoli-
dated Text) of EndoNaut
workstation

Conformity to IEC 60601-2
of the separate Workstation
for navigation tools

Identical
IEC 60601-2 FDA recog-
nized standard version is ap-
plied and included in V&V
protocol and results.

Conformity to IEC 60601-1-
6 of EndoNaut workstation

Identical
IEC 60601-1-6 FDA recog-
nized standard version is ap-
plied and included in V&V
protocol and results.


510(k) Sponsor
Ever Fortune.AI Co., Ltd.

Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd.
West Dist.
Taichung City 403020
TAIWAN


EFAI ChestSuite XR Pleural Effusion Assessment System

Radiological Computer-Assisted Prioritization Software For
Lesions

Radiological Computer Aided Triage and Notification Software


Company
Ever Fortune.AI Co., Ltd.
Zebra Medical Vision Ltd.

EFAI Chestsuite XR Pleural
Effusion Assessment System is
a software workflow tool
designed to aid the clinical
assessment of adult (18 years of
age or older) Chest X-Ray cases
with features suggestive of
pleural effusion in the medical
care environment. EFAI
Chestsuite XR Pleural Effusion
Assessment System analyzes
cases using an artificial
intelligence algorithm to
identify suspected findings on
chest x-ray images taken in PA
position. It makes case-level
output available to a
PACS/workstation for worklist
prioritization or triage. EFAI
Chestsuite XR Pleural Effusion
Assessment System is not
intended to direct attention to
specific portions or anomalies of
an image. Its results are not
intended to be used on a stand-
alone basis for clinical decision-
making nor is it intended to rule
out pleural effusion or otherwise
preclude clinical assessment of

The Zebra HealthCXR device is
a software workflow tool
designed to aid the clinical
assessment of adult Chest X-Ray
cases with features suggestive of
pleural effusion in the medical
care environment. HealthCXR
analyzes cases using an artificial
intelligence algorithm to identify
suspected findings. It makes
case-level output available to a
PACS/workstation for worklist
prioritization or triage.
HealthCXR is not intended to
direct attention to specific
portions or anomalies of an
image. Its results are not intended
to be used on a stand-alone basis
for clinical decision-making nor
is it intended to rule out pleural
effusion or otherwise preclude
clinical assessment of X-Ray
cases.

Table - Comparison with the Predicate Device.


Supported Modalities
X-Ray (PA view)
X-Ray (PA or AP view)

Clinical condition
Pleural Effusion
Pleural Effusion

Yes; Passive notification
flagged for review

Yes; notification flagged for
review on hospital worklist

Where results are
PACS / RIS / Workstation
PACS / Workstation


Medical Device Software - Software
Life Cycle Processes

Digital Imaging and Communications in
Medicine (DICOM)

Application of Risk Management to
Medical Devices

Application of usability engineering to
medical devices

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

The device meets the following recognized US FDA Consensus Standards:


DHT8B: Division of Radiological Imaging Devices

Office of Product Evaluation and Quality


510(k) Sponsor
Synapsica Healthcare, Inc.

2591 Dallas Parkway Suite 300
Frisco, TX 75034

Rory A. Carrillo
Regulatory Consultant | Cosm

Email: rory@cosmhq.com
Phone: (562) 533-7010


Automated Radiological Image Processing Software

Medical Image Management and Processing System


Intended Users
Qualified medical practitioners
Radiologists

Yes, only through the optional
SpindleX module (Cervical, Lumbar
and others for digital x-rays of
spine)

Yes, only through the optional
SpindleX module
(Flexion, extension or neutral)

6. Comparison of Technological Characteristics with Predicate Device


Only through the optional SpindleX
module the following measurements
are provided:
-Ruth Jackson’s angle
-Ferguson's angle
-Canal diameter
-Displacement of L3 vertebrae
-Vertebral offset
-Motion Segment Integrity,
Translational & Angular

-Linear measurements
-Angular measurements
-Vertebral body detection
-Vertebral body landmark
specification
-Vertebral body registration


Measurement for pathology
Radiologists ICC
Rads & Model ICC

Stress Lines (degrees)
0.957 (E)
0.953 (E)

Vertebral Offset Neutral (mm)
0.698 (M)
0.707 (M)

Angular MSI (degrees)
0.769 (G)
0.781 (G)

Translational Motion 5th Edition (mm)
0.712 (M)
0.717 (M)

Translational Motion 6th Edition - Flexion
(mm)

Translational Motion 6th Edition - Extension
(mm)

The following tables capture the aided versus unaidedagreement:


Stress Lines (degrees)
0.979 (E)
0.968 (E)


Ferguson’s Angle (degrees)
0.968 (E)
0.939 (E)

Integrity of 3rd Lumbar Vertebra (mm)
0.997 (E)
0.996 (E)

Vertebral Offset Neutral (mm)
0.820 (G)
0.777 (G)

Angular MSI (degrees)
0.792 (G)
0.771 (G)

Translational Motion 5th Edition (mm)
0.710 (M)
0.656 (M)


Radiological computer assisted detection/diagnosis software for fracture


BoneView 1.1-US is a software-only device intended to assist clinicians in the interpretation of:

• limbs radiographs of children/adolescents and

• limbs, pelvis, rib cage, and dorsolumbar vertebra radiographs of adults.

BoneView 1.1-US can be deployed on-premise or on cloud and be connected to several computing

platforms and X-ray imaging platforms such as X-ray radiographic systems, or PACS. More precisely,

• In the cloud with a PACS as the DICOM Source

• On premise with a PACS as the DICOM Source

• On premise with an X-ray system as the DICOM Source

After the acquisition of the radiographs on the patient and their storage in the DICOM Source, the

radiographs are automatically received by BoneView 1.1-US from the user’s DICOM Source through an

intermediate DICOM node (for example, a specific Gateway, or a dedicated API). The DICOM Source can be

the user’s image storage system (for example, the Picture Archiving and Communication System, or PACS),

or other radiological equipment (for example X-ray systems).

Once received by BoneView 1.1-US, the radiographs are automatically processed by the AI algorithm to

identify regions of interest. Based on the processing result, BoneView 1.1-US generates result files in

DICOM format. These result files consist of a summary table and result images (annotations on a copy of

the original images or annotations to be toggled on/off). BoneView 1.1-US does not alter the original

images, nor does it change the order of original images or delete any image from the DICOM Source.

Once available, the result files are sent by BoneView 1.1-US to the DICOM Destination through the same

intermediate DICOM node. Similar to the DICOM Source, the DICOM Destination can be the user’s image

storage system (for example, the Picture Archiving and Communication System, or PACS), or other

radiological equipment (for example X-ray systems). The DICOM Source and the DICOM Destination are not

The DICOM Destination can be used to visualize the result files provided by BoneView 1.1-US or to transfer

the results to another DICOM host for visualization. The users are then able to use them as a concurrent

The general layout of images processed by BoneView is comprising:


Study Type (Anatomical Area of
Compatible Radiographic View(s)
Patient population*

Ankle
Frontal, Lateral, Oblique
Adults & Children/Adolescents

Foot
Frontal, Lateral, Oblique
Adults & Children/Adolescents

Knee
Frontal, Lateral
Adults & Children/Adolescents

Tibia/Fibula
Frontal, Lateral
Adults & Children/Adolescents

Wrist
Frontal, Lateral, Oblique
Adults & Children/Adolescents

Hand
Frontal, Oblique
Adults & Children/Adolescents

Elbow
Frontal, Lateral
Adults & Children/Adolescents

Forearm
Frontal, Lateral
Adults & Children/Adolescents

Humerus
Frontal, Lateral
Adults & Children/Adolescents

Shoulder
Frontal, Lateral, Axillary
Adults & Children/Adolescents

Clavicle
Frontal
Adults & Children/Adolescents

Hip
Frontal, Frog Leg Lateral
Adults only

Ribs
Frontal Chest, Rib series
Adults only

Thoracic Spine
Frontal, Lateral
Adults only

Lumbosacral Spine
Frontal, Lateral
Adults only

*Adults are patient aged above 21 years old and Children/Adolescents are patients aged from 2 to 21 years old.


Operating Point
Dataset
Sensitivity
Specificity

High-sensitivity
operating point (DOUBT
FRACT)

operating point (DOUBT
performance study


Operating Point
Dataset
Specificity
Sensitivity

High-specificity
operating point (FRACT)

operating point (FRACT)
performance study


High-sensitivity operating point
High-specificity operating point

children/adolescents clinical performance study dataset


Clavicle
n(positive)=
113
n(negative)= 45

and high-specificity operating point on the children/adolescents clinical performance study dataset


Performance
Clopper-Pearson CI
Clopper-Pearson CI
Clopper-Pearson CI

examination-level at the high-sensitivity operating point and high-specificity operating point on the merged datasets


High-sensitivity operating point
DOUBT FRACT

Clavicle
n(positive)= 147
n(negative)= 255

Foot
n(positive)= 985
n(negative)=
1,097

and high-specificity operating point on the merged datasets


High-sensitivity op
erating point
High-specificity ope
rating
point

Specificity – 95%
Sensitivity – 95%
Specificity – 95% S
ensitiv
ity – 95%

Clopper-Pearson
Clopper-Pearson
Clopper-Pearson C
loppe
r-Pearson

5 avenue du Généra
l de Gaulle, 94160 Saint-M
andé - FRANCE

SAS au capital de 1
15 372 euros – RCS Créte
il 834 105 470


Clopper-Pearson Clopper-Pearson Clopper-Pearson Clopper-Pearson


Level P, 24 Campbell St
Sydney, NSW 2000
Australia


Device Name
Annalise Enterprise CXR Triage Trauma

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


Annalise Enterprise CXR Triage Pneumothorax


Manufacturer Name
Zebra Medical Vision Ltd.


Pleural effusion
QFM
0.980 (0.972-0.986)

Pneumoperitoneum
QAS
0.969 (0.950-0.984)

study are summarized in the tables below.


Finding
Operating point
Sensitivity (95% CI)
Specificity (95% CI)

Pneumoperitoneum QAS 0.969 (0.950-0.984)


Vertebral compression fracture
AUC: 0.954 (95% CI: 0.939-0.968)


Vertebral compression fracture AUC: 0.954 (95% CI: 0.939-0.968)


The cases were gathered from unique female patients 35 years of

age or older and included different modalities (DBT and FFDM), manufacturers (Hologic and GE),

and exam types (screening and diagnostic).

pivotal study did not overlap with those used previously to collect data for training or testing the


Predicate Device
Aidoc Briefcase (K203508)

Subject Device
Aidoc Briefcase (K222277)

BriefCase is a radiological
computer aided triage and
notification software indicated
for use in the analysis of non-
enhanced head CT and CTPA
images. The device is intended
to assist hospital networks and
trained radiologists in workflow
triage by flagging and
communication of Intracranial
Hemorrhage (ICH) and
Pulmonary Embolism (PE)
pathologies. For the PE
pathology, the software is only
intended to be used on single-
energy exams.
BriefCase uses an artificial
intelligence algorithm to
analyze images and highlight
cases with detected findings on
a standalone desktop
application in parallel to the
ongoing standard of care
image interpretation. The user
is presented with notifications
for cases with suspected
findings. Notifications include
compressed preview images
that are meant for informational
purposes only and not intended
for diagnostic use beyond
notification. The device does
not alter the original medical
image and is not intended to be
used as a diagnostic device.

BriefCase is a radiological
computer aided triage and
notification software indicated
for use in the analysis of CTPA
images in adults or transitional
adolescents aged 18 and older.
The device is intended to assist
hospital networks and
appropriately trained medical
specialists in workflow triage by
flagging and communication of
suspected positive findings of
Pulmonary Embolism (PE)
pathologies.
BriefCase uses an artificial
intelligence algorithm to
analyze images and highlight
cases with detected findings on
a standalone desktop
application in parallel to the
ongoing standard of care
image interpretation. The user
is presented with notifications
for cases with suspected PE
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


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

Anatomical Region of Interest
Chest
Chest

Notification-Only (/notification
alerts), Parallel Workflow Tool

No. No cases are removed
from Worklist or deprioritized.

No. No cases are removed
from desktop application or
deprioritized.

Inclusion/
Exclusion Criteria for Clinical
Performance Testing

Inclusion criteria
CT pulmonary angiogram
●
(CTPA) with a 64-slice
scanner or higher;
Slice thickness 0.5 mm –
●
3.0 mm.
Scans performed on adults/
●
transitional adults ≥ 18
years of age.
Exclusion Criteria
All studies that are
●
technically inadequate,
including studies with
motion artifacts, severe
metal artifacts, sub-optimal
bolus timing or an
inadequate field of view.


Artificial intelligence algorithm
with database of images.

- AHS module (image
acquisition);
- ACS module (image
processing);
- Aidoc Worklist application
for workflow integration
(worklist and non-diagnostic
Image Viewer).

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


Table 4. Frequency Distribution of Gender


Table 5. Frequency Distribution of manufacturer


Patient data management
Patient data management
Yes


Both systems use standard office PCs as hardware platform.

Both systems use Windows 10 Professional (or higher) and
Windows Server 2012 R2 (or higher).

RayStation 11B and RayStation 12A are intended for the
same target population and anatomical sites; persons that
have been prescribed an external beam radiation therapy or
medical oncology treatment.

Anatomical sites
Substantially Equivalent

In terms of human factors, the systems are considered
equivalent. The user interfaces are almost identical.

Both systems comply with the following FDA-recognized
consensus standards: IEC 61217:2011, IEC 62083, IEC
62304:2015, IEC 62366-1:2015, ISO 14971:2019 and with
IEC 60601-2-68:2014 standard.

RayStation 11B and RayStation 12A both support CT, PET
and MR images for identifying patient organs and contouring.

When evaluating and approving treatment plans, all necessary
data is presented to the user and available in print in both
systems.

None of the systems is intended for long term storage of
images or other patient data.

Network / remote
connections and
capabilities

Both systems are capable of network transfer of patient data
using the DICOM protocol. RayStation 12A and RayStation
11B are designed for desktop use and for remote access using
standard virtualization techniques. Remote connection to the
system is verified in detail and equivalent to local connection.

RayStation 12A is compared to the predicate device RayStation 11B.


Displays the patient geometry and
structures in three dimensions, with the
possibility to rotate the patient image. If
available, the dose distribution and beam
modifiers are shown as well.

The process of replanning the treatment
for a patient, based on information about
e.g. patient geometry, biology and dose
delivery acquired during treatment.

Modeling of the radiation beam using a
limited set of measurements on the clinical
beam for commissioning treatment
machines to make them available for
treatment planning.

Definition of beam orientations, apertures
and various beam modifiers in order to
manually create a treatment plan.

Manual or automatic definition of
isocenter, selection of treatment unit from
the set of commissioned treatment
machines, and specification of
gantry/couch/collimator angles.

Yes, new
functionality
Automatic
Field in Field
planning was
added.

Displays the beam’s eye view of the
patient structures, fluence and beam
modifier settings for any beam.

Tools for planning of HDR brachytherapy
treatments. Includes channel
reconstruction and optimization and
editing of dwell times.

Yes. Now
supports
Elekta
Flexitron
afterloaders.

CyberKnife planning is completely
integrated in RayStation. This includes
optimization of high quality treatment
plans collimated with MLC, fixed cones
or iris cones, as well as support for all
CyberKnife Synchrony techniques for
target tracking and real time motion
synchronization.

Establishing a point-to-point mapping
between two images using a deformation
model. Used for mapping of dose and
structures between images.


Export of images, structure set, plan, and
dose according to the DICOM RT
standard.

Import of images, structure set, plan, and
dose according to the DICOM RT
standard.

For electron beams RayStation calculates
dose by the Monte Carlo technique. The
electron beam phase space is generated in
run time by sampling from a phase space
model where the electrons are created at
the secondary scattering foil. Both the
electron transport through the treatment
head and the in-patient dose computation
is performed using the Monte Carlo
algorithm.
In versions prior to RayStation 11A, the
transport through the treatment head has
been handled by a Monte Carlo algorithm
developed by RaySearch, while the in-
patient transport and dose computation has
been the responsibility of the plug-in dose
engine VMC++. In RayStation 12A, the
VMC++ dose engine has been exchanged
with an in-patient Monte Carlo transport
and dose scoring algorithm fully
developed by RaySearch. Additionally,
some minor improvements have been
made to the treatment head transport, but
this part is essentially the same as in
RayStation 11B.
There are substantial similarities between
the replaced VMC++ code and the
EGSnrc code and these two Monte Carlo
dose engines agrees on sub-percent level
[1][2]. The dose engine developed by
RaySearch is similar to the EGSnrc, as has
been described in references 11, 12, 17, 24
and 108 in the 008 RSL-D-RS-12A-REF-
EN-1.0-2022-06-23 RayStation 12A
Reference Manual. Therefore, we
conclude that the electron dose engine
used in RayStation 12A (fully developed
by RaySearch) is substantially equivalent
to the electron dose engine used in
RayStation 11B (in-patient dose
computation handled by VMC++).


The supporting testing confirms
equivalence between the RayStation 11B
and RayStation 12A dose engines.
Regression tests performed during the
electron dose engine validation between
the two versions are within tolerance
limits which shows a similar level of
accuracy between the two dose engines.
Acceptance criteria for comparison with
previous RayStation dose: The calculated
doses shall fail for less than 2% of the data
points for gamma 2%/2mm.
References:
[1] Kawrakow I and Fippel M, "VMC++,
a MC algorithm optimized for electron
and photon beam dose calculations for
RTP," Proceedings of the 22nd Annual
International Conference of the IEEE
Engineering in Medicine and Biology
Society (Cat. No.00CH37143), Chicago,
IL, USA, 2000, pp. 1490-1493 vol.2, doi:
10.1109/IEMBS.2000.898024.
[2] Kawrakow I, Fippel M, Friedrich K.
3D electron dose calculation using a
Voxel based Monte Carlo algorithm
(VMC). Med Phys. 1996 Apr;23(4):445-
57. doi: 10.1118/1.597673. PMID:
9157256.

For photon beams RayStation calculates
dose by the point kernel superposition
method (a.k.a. Collapsed Cone) or a
Monte Carlo algorithm for radiation
transport. The incident energy fluence is
modeled as a superposition of a primary
energy fluence and a scatter energy
fluence. The dose contribution from
contamination electrons is calculated by a
pencil beam algorithm.

For proton beams RayStation uses either
the pencil beam algorithm with the Fermi-
Eyges formalism, or a Monte Carlo
algorithm for radiation transport. For
passive beams the beam model accounts
for the collimator and compensator block.
For scanning beams the beam model
accounts for the spot phase space
including effects of air-scatter and beam
paths through magnetic deflection
elements. The user defined block aperture
is taken into account in spot selection and
optimization. In addition to this the
relative biological effect (RBE) of proton
beams is taken into account, resulting in a
photon equivalent dose.


For brachy plans RayStation calculates
dose based on the TG43 formalism.

Displays the patient geometry with
structures superimposed on the image data
together with the dose distribution in
transversal, sagittal, and coronal
directions.

Dose tracking scenarios including
deformable registration of one CT or
CBCT to another and subsequent
deformation and accumulation of dose.

Tools for specifying a highly detailed
geometrical model of the eye based on
measurements from ultrasound and
surgery. Support for positioning of
tantalum clips. Import and visualization of
fundus images. Creation and dose
computation of proton plans with gaze
angle-based treatment directions.

Yes, Now
supports eye
planning with
wedges.

Automatic generation of fallback plans
using alternative treatment machines and
treatment techniques. User-defined
protocols specifies the setup of the
fallback plans which are automatically
generated from the protocols and
optimized using dose mimicking
functions.

Conversion of CBCT images to synthetic
CT images that can be used for more
accurate dose calculations.

The user can define optimization settings
such as optimization tolerance and
maximum number of iterations as well as
segmentation settings on the multileaf
collimator and the Pencil Beam Scanning
spot pattern. An interface for controlling
the optimization process is provided and
the progress of optimization is displayed
in a view. The system generates control
points for step-and shoot MLC plans,
Sliding Window plans (DMLC), rotational
plans (VMAT), 3DCRT plans, Wave Arc
plans, TomoTherapy plans and proton
Pencil Beam Scanning plans, using the
defined optimization problem. The inverse
planning can be carried out either through
a conventional inverse approach or by
using multi-criteria optimization (photons
and protons only).


Computation and evaluation of dose-
averaged LET (Linear Energy Transfer)
for proton plans. LET is an additional
physical quantity that can be used to
assess the radiobiological effect of the
proton radiation.

Microsoft SQL database for storage of
beam model parameters, machine
constraints and dose curves with
dosimetric data for treatment units.

Allowing MR-images as planning images
and base dose computation on material
override ROIs.

The optimization functions are specified in
terms of objectives and constraints to form
the optimization problem that is solved by
the optimization engine.

Manual and semi-automatic segmentation
tools for contouring ROIs slice by slice
together with semi-automated generation
of the patient outline ROI.
The model-based segmentation technique
allows for semi-automatic delineation of
structures by matching 3D shape models
of the structures to new image data.
With atlas-based segmentation, the user
can define templates consisting of already
segmented image data and use this
template for segmentation of new patient
images.
With deep learning segmentation, the user
can use trained deep learning models for
automatic segmentation of new patient
images. (The model training is performed
offline on clinical CT and structure data.)

Microsoft SQL database for storage of all
patient and plan data. Not for long term
storage.

The system computes a large set of plans
according to given rules and the user is
provided with tools to select good plans
from these.

Tools for transferring the clinical plan to a
phantom and recalculate dose. The output
is the dose distribution in DICOM format
or a 2D dose plane and a QA report.
Predicted EPID response is retrieved by
photon dose computation in a specially
designed phantom.


RBE (Relative Biological Effectiveness)
models can be defined and commissioned.
For proton treatments, the user can select
whether to look at RBE-corrected dose or
physical dose. Dose summation is only
possible for photon doses and RBE-
corrected proton doses.

Tools used to answer questions of how the
dose distribution would appear if the
patient setup at the time of treatment does
not fully correspond to the planning CT. A
model of patient uncertainties such as CT
inaccuracy and setup errors is used to
compute a set of scenario doses for
evaluation.

Optimization where a model of patient
uncertainties such as CT inaccuracy, setup
errors or organ motion is used during the
optimization.

Scripting gives programmatic access to
functionality, excluding user risk
mitigations. Through scripting, the clinic
specific procedures can be automated. The
operating system and other applications
can be accessed.

Hardware based license, preventing
unauthorized useable copies to be made.
Checksum control of binary files to
prevent tampering. Data in the patient and
machine databases only available for users
with administrator rights.

Planning for TomoTherapy machines is
completely integrated in RayStation. Also
provides tools for selection of targets and
imaging angles for the TomoTherapy
machine to use for target tracking during
delivery.

A general concept where the treatment
plan is adapted during the course of
treatment. Tools available today include
deformable dose accumulation, CBCT
dose calculation and replanning scenarios.

Approval of the preferred treatment plan
and referenced ROIs by authorized
medical staff. Once a treatment plan is
approved, it is locked for any further
modification.


Treatment plan creation with specification
of plan properties such as number of
fractions and delivery technique.

Evaluation of a single plan. Comparison
of dose distributions and DVH curves of
two or three plans.

An approved plan can be assigned to
fractions in a treatment course and sent to
the treatment delivery device. RayTreat
offer treatment room interfaces for patient
positioning, imaging and plan delivery.

The undo stack is saved to the database,
enabling recovery of RayStation after
crash. The user may redo all or selected
changes at reopen of patient after crash.

Setup of isocenter, beam arrangements
and basic aperture design. Export to laser
systems for patient marking.


Hospital networks and trained
radiologists

Hospital networks and appropriately
trained medical specialists

Chest and Thoraco-abdominal CT
angiography

CT exams with contrast (CTA and CT
with contrast) that include the chest


Notification-only
(notification
alerts), parallel
workflow tool

Artificial intelligence algorithm with
database of images.

- PE and AD image processing
applications
- Compatibility of use with the
CINA Platform reference device
(worklist and Image Viewer)

- AHS module (orchestrator, image
acquisition);
- ACS module (image processing);
- Aidoc Desktop application for
workflow integration (feed and non-
diagnostic Image Viewer).


Table 5. Frequency Distribution of Manufacturer


Feature
Subject Device
Predicate Device
Result

Detection of
coronary
calcium &
quantification of
coronary
calcium volume

Calcium Detection with
deep learning-based
algorithm

Color overlay of MPR
and VRT with
evaluation results

Landmark Detection
with deep learning-
based algorithms, 9
AHA positions

Aorta Segmentation
with deep learning-
based algorithm with
improved performance
by adding training data
(+ 267 additional
annotations)

Modified: improved
performance of the
algorithm

Aorta diameter
measurements at nine
predefined locations
according to the AHA
guidelines and at the
locations of the

Threshold-based
classification of
diameters into different
categories

Modified: maximum
diameter of ascending
and descending aorta
added

Table 1 Comparison of technological characteristics


maximum diameter of
the ascending and
descending aorta

Visualization of
aorta’s VRT and
as cross-
sectional MPRs

Visualization VRT and
cross-sectional MPRs at
nine predefined
locations according to
the AHA guidelines and
of the maximum
diameter of ascending
and descending aorta

Modified:
maximum diameter of
ascending and
descending aorta added

Categorization of
diameter measurements
at locations according
to the AHA guidelines
and at locations of the
maximum diameter of
ascending and
descending aorta

Results in form of
quantitative, structured
and textual reports, and
DICOM Secondary
Capture as well as
DICOM Structured
Report (TID 1500)

Modified: format of
DICOM report changed

Cloud and Edge (on-
premise) deployments


Medical Devices – Application
of usability engineering to
medical devices [including
Corrigendum 1 (2016)]

Medical Devices – application
of risk management to medical
devices

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

Digital Imaging and
Communications in Medicine
(DICOM) Set


Predicate Device
FDA Clearance
FDA Clearance
Main Product Code

Table 3 Predicate device for AI-Rad Companion (Cardiovascular)


Deep learning based segmentation of
vertebras


Distance measurements based on
segmentation results and comparison
with neighboring measurements

HU measurements based on
segmentation results

Deep learning image to image
network for 3D segmentation

Deployment
Cloud and on-premise deployment
Cloud deployment

Quantitative, Structured and Text
reports with DICOM secondary
capture & TID 1500 in both human
and machine readable formats.

Quantitative, Structured and Text
reports with DICOM secondary
capture images


Medical Devices – application
of risk management to
medical devices

with the following voluntary FDA recognized Consensus Standards listed in Table 2.


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

Information Technology –
Digital Compression and
coding of continuous -tone
still images: Requirements
and Guidelines [including:
Technical Corrigendum
1(2005)]

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

Health software – Part 1:
General requirements for
product safety


Mislabeling of Vertebrae or absence of height
measurement

Ratio of cases that are mislabeled or missing
measurements shall be <10% of all cases

Inter-reader variability: heights calculated by
AIRC & the ground truth should be within the
LoA reported

For cases with slice thickness ≤1.0 mm, the
difference should be within the LoA for ≥95%
of cases

For cases with slice thickness >1.0mm, the
difference should be within the LoA for ≥85%
of cases

Consistency of height and density
measurement across critical sub-groups

For each sub-group, the ratio of
measurements within the corresponding LoA
should not drop by more than 5% compared
to the ratio for all data sets


For cases with slice thickness ≤1.0 mm, the
difference was 95.5%

For cases with slice thickness >1.0mm, the
difference was 92.6%

Overall failure rate of the subject device was
consistent with the predicate as well as having
the results of all sub-group analysis rated
equal or superior to the predicate


140 Chest CTs (1,553 thoracic vertebrae)

KUM (N=80):
Primary indications: Lung/airways 10; infect focus 10; malignancy 22,
follow-up 10; (cardio-)vascular 14; ischemia 2; bleeding 4; trauma 1;
lymph nodes 3; inflammation 1; unknown 3.
NLST (N=60):
Comorbidities: diabetes 7; heart disease 10; hypertension 24; cancer 9;
emphysema/COPD 14; asthma 2; pneumonia 13; chron. bronchitis 1.
Smoking history (pack years): median: 47, IQR: [38, 70]

GE: 32, Philips: 20, Siemens: 68, Toshiba: 20

KUM: CTDIVol [mGy]: median 4.8, IQR: [1.3, 10.7]
NLST: low dose (screening)

Filtered backprojection: 107
Iterative reconstruction: 33

Reconstruction
soft: 25, medium: 68, hard: 47


DHT8B: Division of Radiological Imaging Devices and

Office of Product Evaluation and Quality


Regulation Number
Regulation Name
Product Code

Medical Image Management and Processing System

Regulation Number, Name and Product Code:


Device Trade Name:
LVivo Software Application

Manufacturer Name:
DiA Imaging Analysis Ltd

Automated Radiological Image Processing Software


Manufacturer Name:
Smart Soft Healthcare AD


Device Trade Name:
AI-Rad Companion (Musculoskeletal)

Manufacturer Name:
Siemens Medical Solutions USA, Inc.

Regulation Name:
Computed tomography x-ray system

Device Classification Name:
Computed tomography x-ray system


Clarius Ultrasound Transducers
L7 and L15

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


Criteria
SUBJECT DEVICE
PREDICATE DEVICE
REFERENCE DEVICE #1
REFERENCE DEVICE #2
RATIONALE

Clarius AI
LVivo Software
CoLumbo
AI-Rad Companion
differs from predicate

Same as predicate
device and reference
device #1

Automated
Radiological Image
Processing Software

Medical Image
Management and
Processing System

Non-invasive
processing of
ultrasound images
using automatic image
segmentation and
measurement of
anatomical structures
utilizing artificial
intelligence
algorithms.

Non-invasive
processing of MR
images using
automatic image
segmentation and
measurement of
anatomical structures
utilizing artificial
intelligence
algorithms.

Non-invasive
processing of CT
images using
automatic image
segmentation and
measurement of
anatomical structures
utilizing artificial
intelligence
algorithms.

Same as predicate
device and similar to
reference devices

Clarius AI is intended
for use by trained
healthcare
professionals to semi-
automatically place

LVivo platform is
intended for non-
invasive processing of
ultrasound images to
detect, measure, and

CoLumbo is an image
post-processing and
measurement
software tool that
provides quantitative

AI-Rad Companion
(Musculoskeletal) is an
image processing
software that provides
quantitative and

Clarius AI indications
for use are similar to
the predicate device’s
indications for use as
both devices are

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


calipers for non-
invasive anatomical
measurements on
ultrasound data
acquired by the Clarius
Ultrasound Scanner.

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

spine measurements
from previously-
acquired DICOM
lumbar spine Magnetic
Resonance (MR)
images for users’
review, analysis, and
interpretation. It
provides the following
functionality to assist
users in visualizing,
measuring and
documenting out-of-
range measurements:
-Feature
segmentation;
-Feature
measurement;
Threshold based
labeling of out of
range measurement;
and
-Export of
measurement results
to a written report for
user’s review, revise
and approval.
CoLumbo does not
produce or
recommend any type
of medical diagnosis or
treatment. Instead, it
simply helps users to

qualitative analysis
from previously
acquired Computed
Tomography DICOM
images to support
radiologists and
physicians from
emergency medicine,
specialty care, urgent
care, and general
practice in the
evaluation and
assessment of
musculoskeletal
disease. It provides
the following
functionality:
-Segmentation of
vertebras
-Labelling of vertebras
-Measurements of
heights in each
vertebra and
indication if they are
critically different
-Measurement of
mean Hounsfield value
in volume of interest
within vertebra.
Only DICOM images of
adult patients are
considered to be valid
input.

indicated for non-
invasive processing of
ultrasound data/
images for
measurements of
anatomical structures.


Criteria
SUBJECT DEVICE
PREDICATE DEVICE
REFERENCE DEVICE #1
REFERENCE DEVICE #2
RATIONALE

Clarius AI
LVivo Software
CoLumbo
AI-Rad Companion
differs from predicate

more easily identify
and classify features in
lumbar MR images and
compile a report. The
user is responsible for
confirming/ modifying
settings, reviewing and
verifying the software-
generated
measurements,
inspecting out-of-
range measurements,
and approving draft
report content using
their medical
judgment and
discretion.
The device is intended
to be used only by
hospitals and other
medical institutions.
Only DICOM images of
MRI acquired from
lumbar spine exams of
patients aged 18 and
above are considered
to be valid input.
CoLumbo does not
support DICOM images
of patients that are
pregnant, undergo
MRI scan with contrast
media, or have post-


Same as predicate
device and reference
devices

Although the
anatomical sites/
structures for use of
the predicate device
(bladder, heart) are
different from the
subject device (foot,
ankle, knee), the
predicate device and
subject device share a
very similar intended
use in terms of
identifying/ viewing,
measuring/
quantifying and
reporting results
acquired by ultrasound
devices for non-
invasive
measurements of
anatomical structures
utilizing artificial


Healthcare setting
(e.g., hospital, clinic)


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

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

NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set

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

ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied


syngo Dynamics is a multimodality, vendor
agnostic Cardiology image and information
system intended for medical image management
and processing that provides capabilities relating
to the review and digital processing of medical
images.
syngo Dynamics supports clinicians by providing
post image processing functions for image
manipulation, and/or quantification that are
intended for use in the interpretation and analysis
of medical images for disease detection,
diagnosis, and/or patient management within the
healthcare institution’s network.
syngo Dynamics is not intended to be used for
display or diagnosis of digital mammography
images in the U.S.

syngo Dynamics is a multimodality, vendor
agnostic Cardiology image and information
system intended for medical image management
and processing that provides capabilities relating
to the review and digital processing of medical
images.
syngo Dynamics supports clinicians by providing
post image processing functions for image
manipulation, and/or quantification that are
intended for use in the interpretation and analysis
of medical images for disease detection,
diagnosis, and/or patient management within
healthcare institution’s network.
syngo Dynamics is not intended to be used for
displaying of digital mammography images for
diagnosis in the U.S.

syngo Dynamics (Version VA40F) Traditional 510(k) Submission


Architecture Client-server Client-server Identical

• Standalone medical device
including a DICOM Server
• Integrated model within an
Electronic Health Record
(EHR) System with a
DICOM Archive
• Multimodality
Cardiovascular (MMCV)
deployment with native
support of 2D/3D CT/MR
image types

Within the network, the
following communication
protocols are used:
• TCP/IP: for communication
and transport
• DICOM and HL7 at
application level
• HTTP for communication
and transport of images,
MP4s and thumbnails

Within the network, the
following communication
protocols are used:
• TCP/IP for communication
and transport
• DICOM and HL7 at
application level
• HTTP(S) for
communication and
transport of images, MP4s
and thumbnails

Lossless compression with
compression factor 2 to 3 and
lossy compression (JPEG and
MP4) with higher compression
rate.


• Window/Leveling
• Edge Enhancement
• Digital Subtraction
• Multiplanar reconstruction
(MPR)
• Maximum and Minimum
Intensity Projection
(MIP/MinIP)
• Volume Rendering
Technique (VRT)
• Gamma Correction
• Manual and semi-
automated calculation for
left ventricular ejection
fraction (Auto EF)

• Window/Leveling
• Edge Enhancement
• Digital Subtraction
• Multiplanar reconstruction
(MPR)
• Maximum and Minimum
Intensity Projection
(MIP/MinIP)
• Volume Rendering
Technique (VRT)
• Gamma Correction
• Manual calculation for left
ventricular ejection fraction

Updated by
adding semi-
automated
ejection
fraction

• Pixel Size Evaluation
• Distance line
• Angle
• volume

• Pixel Size Evaluation
• Distance line
• Angle
• Volume

Ability to interface with a third-
party rules engine (BizTalk),
where rules are configured by
the end customer to determine
clinical relevance of selected
observations.
Customers identify and store
selected patient data.
Orchestrations provide a trigger
to pull in previously stored
relevant data for a given study.

• Customizable DICOM
Structured Reporting
• Collaborative reporting
• Web reporting

• Customizable DICOM
Structured Reporting
• Collaborative reporting
• Remote reporting


Access
strategies for
imaging and
reporting

• Workplace (thick client)-
access for reading and
reporting.
• Remote Workplace (MP4
image display with access
to full DICOM image for
US/XA and full DICOM
image for CT/MR) – access
for reading and reporting
• WebViewer – (Web Client
with MP4 Image display) –
Access for review only
• Portal – (Web Client for
reading and reporting with
limited functionality.)

• Workplace (thick client) –
access for reading and
reporting.
• Remote Workplace (MP4
image display with access
to full DICOM image for
US/XA and full DICOM
image for CT/MR) – access
for reading and reporting.
• WebViewer- (Web Client
with MP4 Image display) –
Access for review only

Similar.
Additional
portal access
for review and
limited
functionality
in subject
device.

Yes –Through the Common
Login and Portal Image
Review, images can be viewed
on mobile devices, WebViewer,
supports iOS and Android
devices, but are non-diagnostic
use.

Yes – Through WebViewer,
Supports iOS and Android
devices, but non-diagnostic use.

Provide long term archive and
retrieve of DICOM studies
to/from either VNA (Vendor
Neutral Archive) or HSM
(Hierarchical Storage
Management) archiving
Systems.

Software-only option for server
Workstation: software only
(HW is not part of the medical
device, but needs to meet
recommended requirements as
specified by syngo Dynamics)

Provides virtualization of server
and client machines


Server:
Microsoft Windows server 2016
Standard edition (64
bit)
Microsoft Windows Server
2019 Standard Edition (64
Bit)
Client Software: Microsoft
Windows 10 x64 version
1803 or greater
Portal Website Host:
Microsoft Windows Server
2016 Standard edition (64-bit),
Microsoft Windows Server
2019 Standard edition (64-bit)
Server:
Windows 2012 R2 Server
Standard Edition R2 (64-bit)
Portal Client:
Windows 7 SP1 or higher (64-
bit)
Portal Website Host:
Windows 2012 R2 Server
Standard Edition R2 (64-bit)

Server:
Microsoft Windows server 2016
Standard edition (64
bit)
Microsoft Windows Server
2019 Standard Edition (64
Bit)
Client Software: Microsoft
Windows 10 x64 version
1803 or greater
Portal Website Host:
Microsoft Windows Server
2016 Standard edition (64-bit),
Microsoft Windows Server
2019 Standard edition (64-bit)
Server: Windows 2012 R2
Server Standard Edition R2 (64-
bit)
Portal Client:
Windows 7 SP1 or higher (64-
bit)
Portal Website Host: Windows
2012 R2 Server Standard
Edition R2 (64-bit)

• The use of syngo Dynamics
VA30 server/workplace in
the context of
cardiovascular
configuration.
• EHR/EHS Integrated
configuration with syngo
Dynamics server.
• Multi-modality
cardiovascular
configuration with
native/syngo server and
syngo Dynamics workplace
with native/syngo
components.

• The use of syngo Dynamics
VA40E server/workplace in
the context of
cardiovascular
configuration.
• EHR/EHS Integrated
configuration with syngo
Dynamics server.
• Multi-modality
cardiovascular
configuration with
native/syngo server and
syngo Dynamics workplace
with native/syngo
components.


Manufacturer
AIbolit Technologies, LLC
Ceevra

Ceevra Reveal 2.0
Image Processing System

510(k) Number
Subject Device - TBD
K173274

Radiological Image Processing
System / QIH - LLZ

Radiological Image Processing
System / LLZ

Regulation / Class
21 CFR 892.2050 – Class II
21 CFR 892.2050 – Class II

Aibolit 3D+ 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. It is also
intended as software for
preoperative surgical planning,
training, patient information and
as software for the
intraoperative display of the
multidimensional digital images.
Aibolit 3D+ 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.

Ceevra Reveal 2.0 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. It is also intended as
software for preoperative surgical
planning, and as software for the
intraoperative display of the
aforementioned multidimensional
digital images. Ceevra Reveal
2.0 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.

Capture and enhancement of
(DICOM) digital video images
via software-based conversion
to 2-D and 3-D anatomical
structure images that can be
manipulated for viewing

Capture and enhancement of
(DICOM) digital video images via
software-based conversion to 2-
D and 3-D anatomical structure
images that can be manipulated
for viewing

Intended Users
Health care professionals
Health care professionals

Healthcare facilities such as
hospitals and clinics


AIBOLIT 3D+ is intended for use
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. It is also
intended as software for
preoperative surgical planning,
and as software for the
intraoperative display of multi-
dimensional digital images.
AIBOLIT 3D+ is designed for
use by health care professionals
and is intended to assist the
clinician who is responsible for
making patient management
decisions.

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. 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 2.0 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.

AIBOLIT 3D+ is a software only
device that permits electronic
image uploads, provides image
conversion and allows viewing
on a mobile device or standard
computer monitor.

The Ceevra Reveal 2.0 Video
Processor is a software only
device that permits electronic
image uploads, provides image
conversion and allows viewing on
a mobile device or standard
computer monitor.

Image processing
High-definition digital images
High-definition digital images

Generation of 2D and 3D
images from DICOM data
Organ segmentation and
structure identification
Dimensional and volume
references
Multi-axis image rotation
Organ transparency

Physician uploads DICOM
images and specifies desired
anatomical segments of interest
Radiologist annotates sample
(segments) images

Physician uploads DICOM
images and specifies desired
anatomical segments of interest
Imaging technician annotates
sample (segments) images


Only the radiologist can edit
images following review – User
physicians cannot edit images -
Physicians have option to show
or hide organs on display

Imaging technician can edit
images generated by the system
software – User physicians
cannot edit images - Physicians
have option to show or hide
organs on display

3D image can be displayed on
standard monitor or another
appropriate display

3D image can be displayed on
standard monitor, smart phone
(with separate software) or
Virtual Imaging 3D headset

Organ structure dimensions,
volume, organ labels, patient ID,
image date and demographics

Organ structure dimensions,
volume, organ labels, patient ID
and demographics

Physician user can show or hide
individual organ structures,
zoom capability, rotational
capability and transparency
capability

Physician user can show or hide
individual organ structures, zoom
capability, rotational capability,
transparency capability (current
version)


Length between two points,
for both curved lines
(splines) and straight lines,
including the diameter
(including min, max,
average) resulting from
closed splines and depth of
the LAA

Diameter & depth of LAA
landing zone (LAA module);
distance between points of
interest; diameter of a peri-
device leak (Follow-up
module)

The perimeter of a contour
(closed spline)

Perimeter of LAA landing zone
(LAA module); perimeter of
other contours of interest

Area of LAA landing zone
(LAA module); area of other
contours
of interest

The angle of an object /
structure of interest

Hounsfield value (in
Hounsfield Units, HU) of the
underlying pixels

Signal intensity of pixels in the
regular vs. delayed scan
(Thrombus module); average
signal intensity within distal
LAA (Follow-up module);
intensity of other pixels of
interest

Location in the x-, y-, and z-
planes of a point

Coordinates of points of
interest on a 3D rendering,
for export purposes

measurement application for which it is used.


Subject Device
Primary Predicate
Secondary Predicate

Manufactured by Circle
Manufactured by Circle
Manufactured by Pie Medical Imaging

TruPlan enables visualization and
measurement of structures of the heart
and vessels for:
• Pre-procedural planning and sizing for
the left atrial appendage closure
(LAAC) procedure
• Post-procedural evaluation for the
LAAC procedure
To facilitate the above, TruPlan provides
general functionality such as:
• Segmentation of cardiovascular
structures
• Visualization and image
reconstruction techniques: 2D review,
Volume Rendering, MPR
• Simulation of TEE views, ICE views,
and fluoroscopic rendering
• Measurement and annotation tools
• Reporting tools
TruPlan’s intended patient population is
comprised of adult patients.

TruPlan enables visualization and
measurement of structures of the heart
and vessels for pre-procedural planning
and sizing for the left atrial appendage
closure (LAAC) procedure.
To facilitate the above, TruPlan provides
general functionality such as:
• Segmentation of cardiovascular
structures
• Visualization and image
reconstruction techniques: 2D review,
Volume Rendering, MPR
• Simulation of TEE views, ICE views,
and fluoroscopic rendering
• Measurement and annotation tools
• Reporting tools
TruPlan’s intended patient population is
comprised of adult patients.

3mensio Workstation enables visualization

measurement of structures of the heart
measurement of structures of the heart
and measurement of structures of the

and vessels for:
and vessels for pre-procedural planning
heart and vessels for:

the left atrial appendage closure
closure (LAAC) procedure.
for cardiovascular interventions and

LAAC procedure
general functionality such as:
• Support of clinical diagnosis by

• Segmentation of cardiovascular
quantifying dimensions in coronary

general functionality such as:
• Visualization and image
• Support of clinical diagnosis by

• Segmentation of cardiovascular
reconstruction techniques: 2D review,
quantifying calcifications (calcium

structures
Volume Rendering, MPR
scoring) in the coronary arteries

• Visualization and image
• Simulation of TEE views, ICE views,

reconstruction techniques: 2D review,
and fluoroscopic rendering
To facilitate the above, 3mensio

Workstation provides general functionality

• Simulation of TEE views, ICE views,
• Reporting tools
such as:

and fluoroscopic rendering
• Segmentation of cardiovascular

• Reporting tools
comprised of adult patients.
• Automatic and manual centerline

comprised of adult patients.
reconstruction techniques: 2D review,

Table 2. Indications for Use comparison to predicate devices.


Feature
Subject Device
Primary Predicate
Secondary Predicate

Manufactured by Circle
Manufactured by Circle
Manufactured by Pie Medical

Medical image management and
processing system

Picture Archiving and
Communications System

CT data in DICOM format (vendor
independent)

Semi-automatic initialization of the
landing zone using Machine
Learning techniques; manual
confirmation of the landing zone

Manual initialization and
confirmation of the landing zone

Semi-automatic segmentation for
3D visualization of the left heart
using Machine Learning
techniques; manual editing of 3D
views possible

Semi-automatic segmentation for
3D visualization of the left heart;
manual editing of 3D views possible

• Study/series previewing
• Exporting
• Deleting
• Anonymizing
• Search

• Fluoroscopy (grayscale 3D
rendering), to visualize
relationship among LAAC
procedure relevant
anatomical structures
• TEE, to provide similar views
to intraprocedural TEE
• ICE, to provide similar views
to intraprocedural ICE

• Grayscale 3D rendering, to
visualize relationship among
LAAC procedure relevant
anatomical structures
• TEE, to provide similar views to
intraprocedural TEE

Image assessment –
other visualization
functionality

• 2D
• 3D (with manual & semi-
automatic segmentation)
• 4D (cine)
• MPR
• MIP
• Annotations

• 2D
• 3D (with manual & semi-
automatic segmentation)
• 4D (cine)
• MPR
• Annotations
• Curved MPR
• Stretch CMPR
• Slabbing
• MIP
• AIP
• MinIP
• Centreline extraction
• Calcium coring

Image assessment –
measurement
functionality

• Distance (length, diameter,
perimeter)
• Area
• Angle
• Signal intensity
• Coordinates
• Volume

Report functionality
• Patient/study information
• Patient/study information
• Patient/study information

Table 3. Feature comparison to primary and secondary predicate devices.


Feature
Subject Device
Primary Predicate
Secondary Predicate

Manufactured by Circle
Manufactured by Circle
Manufactured by Pie Medical

• Screenshots
• Measurements
• Free text
• Device sizing table (for
reference only) for LAA
procedure

• Screenshots
• Measurements
• Free text
• Device-specific reports for
procedures covered in intended
use


149New MontgomerySt,4thFloor
SanFrancisco,CA 94105


The data used in the device validation ensured

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

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


Subject Device
Aidoc Briefcase for
Vertebral Compression
Fractures (VCFx) Triage

HealthVCF is a passive
notification for prioritization-
only, parallel-workflow software
tool used by clinicians to
prioritize specific patients
within the standard-of-care
bone health setting for
suspected vertebral
compression fractures.
HealthVCF uses an artificial
intelligence algorithm to
analyze chest and abdominal
CT scans and flags those that
are suggestive of the presence
of at least one vertebral
compression at the exam level.
These flags are viewed by the
clinician in Bone Health and
Fracture Liaison Service
programs in the medical setting
via a worklist application on
their Picture Archiving and
Communication System
(PACS). HealthVCF does not
send a proactive alert directly
to the user.
HealthVCF does not provide
diagnostic information beyond
triage and prioritization, it does
not remove cases from the
radiology worklist, and should
not be used in place of full
patient evaluation, or relied
upon to make or confirm
diagnosis.

BriefCase is a radiological
computer aided triage and
notification software indicated
for use in the analysis of chest
and abdominal CT images. The
device is intended to assist
hospital networks and
appropriately trained medical
specialists within the standard-
of-care bone health setting in
workflow triage by flagging and
communication of suspected
positive cases of Vertebral
Compression Fractures (VCFx)
findings.
BriefCase uses an artificial
intelligence algorithm to
analyze images and highlight
cases with detected findings on
a standalone application in
parallel to the ongoing standard
of care image interpretation.
The device does not alter the
original medical image and is
not intended to be used as a
diagnosis 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 within the standard-
of-care bone health setting.

Anatomical region of interest
Chest and abdomen
Chest and abdomen

Data acquisition protocol
Chest and abdominal CT scans
Chest and abdominal CT scans

Notification-only, parallel
workflow tool

Algorithm
Artificial intelligence algorithm
Artificial intelligence algorithm

- Data input and
validation (to ensure
compatibility for
processing by the
algorithm)
- HealthVCF algorithm.
- Zebra Worklist.

- AHS module (orchestrator,
image acquisition);
- ACS module (image
processing));
- Aidoc Desktop application
for workflow integration
(feed and non-diagnostic
Image Viewer).