Proposed Device
Primary Predicate
Reference Device

brain; it is not intended
to be used with images
of other body parts.
VBrain-OAR also
contains the automatic
image registration
feature to register
volumetric medical
image data. (e.g., MR,
CT). It allows rigid
image registration to
adjust the spatial
position and orientation
of two images.
Radiation therapy
treatment personnel
must finalize (confirm or
modify) the contours
generated by VBrain-
OAR, as necessary,
using an external
platform available at the
facility that supports
DICOM-RT
viewing/editing
functions, such as image
visualization software
and treatment planning
system.

professionals, including
but not limited to
surgeons and
radiologists.

VBrain-OAR is a
software application
system indicated for use
in the contouring
(segmentation) of brain
MRI images for the
organs at risk (OAR) in
the brain during
radiation treatment
planning and in the
registration of multi-
modality images. The
device consists of 2
algorithm modules,
which are contouring

The proposed device,
AccuContour, is a
standalone software
which is used by
radiation oncology
department to register
multimodality images
and segment (non-
contrast) CT images, to
generate needed
information for
treatment planning,
treatment evaluation and
treatment adaptation.

iPlan is a software based
treatment planning
application providing
functionalities like
viewing, processing and
documentation of
medical data including
different modules for
image preparation,
image fusion, image
segmentation where the
result is a treatment plan
that can be used e.g. for
stereotactic and/or image
guided surgery.


algorithm module and
registration algorithm
module, and a workflow
management module.
The modules can work
independently, and yet
can be integrated with
each other.
The contouring
(segmentation)
algorithm module
consists of image
preprocessing, deep
learning neural
networks, and
postprocessing
components, and is
intended to contour
organs at risk in the
brain on the axial T1
contrast-enhanced MR
images. It utilizes deep
learning neural networks
to generate contours for
the organs at risk in the
brain and export the
results as DICOM-RT
objects (using the RT
Structure Set ROI
Contour attribute,
RTSTRUCT).
The registration
algorithm module
registers volumetric
medical image data (e.g.,
MR, CT). It allows rigid
image registration to
adjust the spatial
position and orientation
of two images.
The workflow
management module is
configured to work on a
PACS network. Upon

The product has two
image process functions:
(1) Deep learning
contouring: it can
automatically contour
the organ-at-risk,
including head and neck,
thorax, abdomen and
pelvis (for both male and
female),
(2) Automatic
Registration, and
(3) Manual Contour.
It also has the following
general functions:
Receive, add/edit/delete,
transmit, input/export,
medical images and
DICOM data;
Patient management;
Review of processed
images;
Open and Save of files.


user’s request, it will
pull patient scans or
users can send
corresponding DICOM
images, and it will
trigger a predefined
workflow, in which
different algorithm
modules are executed to
generate the DICOM
output. The DICOM
output of a workflow are
sent back to the PACS.

Segmentation
Deep learning
Deep learning
Atlas-based

Operating System
Linux operating system
Microsoft Windows
Microsoft Windows

Trained radiotherapy
personnel including, but
not limited to,
radiologists, radiation
oncologists, physicians,
dosimetrists, and
medical physicists.

It is used by radiation
oncology department.

Typical users of iPlan
are medical
professionals, including
but not limited to
surgeons and
radiologists.

Segmentation Features
for organs at risk in the
brain: axial T1 contrast-
enhanced MR images.
Registration Features:
CT, MR

Segmentation Features:
Non-Contrast CT
Registration Features:
CT, MRI, PET

Organ-at-risk, including
head and neck, thorax,
abdomen and pelvis (for
both male and female)

Outline anatomical
structures using manual
or automatic
segmentation methods.
Advanced manipulation
for 3D objects with
scaling, logical
operations and object
splitting.

Image Registration
Intensity-based
Intensity-based
Intensity-based


Proposed Device
Primary Predicate
Reference Device


Automatic contouring of imaging data using
machine learning based models

View manipulation and Volume rendering – Not
Applicable

Supported modalities: Standard DICOM image
modality support


Subject device
validated with CT
images for image
processing.


Predicate device
validated with CT,
MR, DICOM
RTSTRUCT for
image processing.


Manufacturer
Circle Neurovascular Imaging
Viz.AI

Radiological Computer-Assisted
Triage And Notification Software

Regulation number
21 CFR 892.2080
21 CFR 892.2080

StrokeSENS LVO is a
radiological computer-aided
triage and notification (CADt)
software indicated for use in the
analysis of CTA head images.
The device is intended to assist
hospital networks and trained
clinicians in workflow triage by
flagging and communication of
suspected positive findings of
Large Vessel Occlusion (LVO) in
head CTA images.
StrokeSENS LVO uses a
software algorithm to identify
suspected LVO findings. In the
case of a suspected LVO, the
system will send a notification to
a pre-configured destination(s),
notifying the clinicians of the
existence of a suspected LVO
that requires review. The
notification system is intended to
be used in parallel to the standard
of care workflow to notify
clinicians of the existence of the
case earlier that they may have
been notified as part of the
standard of care workflow.
Notifications may include a
compressed preview of images.
Notifications are meant for
informational purposes only and
are not intended for diagnostic
use beyond notification. The
StrokeSENS LVO device does
not alter the original medical

ContaCT is a notification-only, parallel
workflow tool for use by hospital networks
and trained clinicians to identify and
communicate images of specific patients
to a specialist, independent of standard of
care workflow.
ContaCT uses an artificial intelligence
algorithm to analyze images for findings
suggestive of a pre-specified clinical
condition and to notify an appropriate
medical specialist of these findings in
parallel to standard of care image
interpretation. Identification of suspected
findings is not for diagnostic use beyond
notification. Specifically, the device
analyzes CT angiogram images of the
brain acquired in the acute setting, and
sends notifications to a neurovascular
specialist that a suspected large vessel
occlusion has been identified and
recommends review of those images.
Images can be previewed through a
mobile application. Images that are
previewed through the mobile application
are compressed and are for informational
purposes only and not intended for
diagnostic use beyond notification.
Notified clinicians are responsible for
viewing non-compressed images on a
diagnostic viewer and engaging in
appropriate patient evaluation and
relevant discussion with a treating
physician before making care-related
decisions or requests. ContaCT is limited
to analysis of imaging data and should not
be used in-lieu of full patient evaluation or
relied upon to make or confirm diagnosis.


image and is not intended to be
used as a diagnostic device.
The results of StrokeSENS LVO
are intended to be used in
conjunction with other patient
information and based on
professional judgement, to assist
with triage / prioritization of
medical images. Notified
clinicians are responsible for
viewing full images per standard
of care.

Hospital Networks and trained
clinicians

Relationship to
standard of care
workflow

CTA data in DICOM format
(vendor independent)

CTAdata in DICOM format (vendor
independent)

Artificial Intelligence / Machine
Learning
Algorithms are static and locked.
Algorithms are not dynamic or
learning while in the market.

Email, Workstation, Mobile
Notification message of
Suspected LVO


Mean: 0.75 mins
S.D: ±0.17 mins
Min: 0.46 mins
Max: 1.23 mins


Printerbracket
It is usedfor holdingthe printer

It is usedfor keeping thecases, towelette, etc.

Configured withthe airstation tocharge themain unit.

Cover wired power into wireless to provide power for Air
Charge Module

The iVocal Plus is an improvement of iVocal (cleared in
K210699), which both enables the system to perform
operations through vocal commands and through tapping
icons on the touch screen. The iVocal Plus Microphone
array is a hardware used with iVocal Plus, it consists of
microphone arrays (including wireless transceivers) and
USB cables.

The Ultrasound System supportsinterconnecting
information withthebedside device through X-Link. The


interconnection function of X-Link mainly includes:
Obtaining data:Thedata ofthesame patient are matched
through network connection;
Using data:Real-timedata are obtained and displayed in
combination with ultrasound image data;
Storing andreviewing data:The dataare stored in
combination with theultrasound image dataand canbe
reviewed ontheultrasound device.

It is an AI(artificial intelligence) based feature.
It is usedto recognizetheinterscalene and supraclavicular
brachial plexus.It isintended for visualization purpose only
and not intended forliveguidance during interventional
procedure.


Enhanced Feature Software Pack for CXDI Series

As a part of the Canon radiography system, the CXDI
Control Software when used with a compatible Canon
detector is intended to provide digital image capture,
processing, and display for conventional film/screen
radiographic examinations. This device is intended to
replace radiographic film/screen systems in all general
purpose diagnostic procedures including specialist
areas like intensive care, trauma, and pediatric work.
This device is not intended for fluoroscopic,
angiographic, or mammography applications.

As a part of the CXDI series radiography system, the
CXDI Control Software when used with a compatible
CXDI detector is intended to provide digital image
capture, processing, and display for conventional
film/screen radiographic examinations. This device is
intended to replace radiographic film/screen systems
in all general purpose diagnostic procedures including
specialist areas like intensive care, trauma, and
pediatric work. This device is not intended for
fluoroscopic, angiographic, or mammography
applications.

An image can be created (with high contrasts) by
using software algorithm, in clinical field, without a
grid

One exposure to obtain images across multiple
detectors, automatically stitched together with ability
to make manual adjustments after the automatic
stitching.

Process to reduce noise from the taken images by
using function machine trained on characteristics of
noises included in X-ray image signals using an
existing clinical image database


Software package that operates on
off-the-shelf hardware

Software package that operates on a
virtual machine within the off-the-shelf
hardware

The software processes DICOM
compliant image data, including
RTSTRUCT

The software is designed for use on a
radiotherapy workstation with a native
user interface.

The software is designed for use on a
radiotherapy workstation with a web-
based user interface

Table 1. Summary of Technological Characteristic Comparison


Model-based approach using a library
of expert contours

Detailed
Implementation
of Segmentation
Algorithm

Smart Segmentation – knowledge-
based contouring used an atlas-based
method to deform expert contours to
the target images to generate contours

INTContour used a machine learning-
based method to train CNNs from
expert contours to perform
segmentation on the target images to
generate contours


Head and Neck
Thorax
Abdomen
Male Pelvis

Brainstem Pituitary SpinalCanal Spleen Bladder

The table below shows the list of all supported organs:


Product
Marketed by
510(k) Number
Clearance Date

Aplio i900/i800/i700 Diagnostic
Ultrasound System, Software
V5.1


K182834 (Predicate Device)
CS-series-FP with optional CA-100S

(This Submission)
Soteria AI, Model AI-100

The Omega Medical Imaging, LLC CS-series-

The Omega Medical Imaging, LLC AI-100,
Soteria.AI (SSXI) systems withFluoroShield/CA-
100S device to providean automated Region of
interest that reduces exposure to the patient and
operator. The System isintended for use in
Radiographic/fluoroscopic applications,including
cardiac, vascular, general radiographic/fluoroscopic
diagnostic, and interventional x-ray imaging for
General Populations.

FP (SSXI) systems with optional accessory

device CA-100S as a modification device to

reducesexposure to the patient and operator.

Image-intensified Fluoroscopic X-ray system


Classification
JAA, OWB
JAA, OWB
JAA, OWB
JAA, OWB


fractures during the review of radiographs of:


GLEAMER SAS
5, avenue du Général de Gaulle
94160 Saint-Mandé - FRANCE

Antoine Tournier
Head of Quality & Regulatory Affairs
Tel: 0033 6 15 81 23 45
Email: antoine.tournier@gleamer.ai

Christian Allouche
CEO
Tel: 0033 6 58 53 70 46
Email: christian@gleamer.ai


Radiological computer assisted detection/diagnosis software for
fracture


Imagen Technologies, Inc - FractureDetect


BoneView can be deployed on-premises or on cloud and be connected to several computing

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

● In the cloud with a PACS as the DICOM Source

● On-premises with a PACS as the DICOM Source

● On-premises with an X-ray system as the DICOM Source

It is important to note that no matter the deployment mode that is chosen for BoneView, the

overall principle of use of BoneView and its user interface remain the same; only the place

where BoneView is housed, and the DICOM Source/DICOM Destination with which BoneView

communicates, may vary. Below is a description of the data flow.

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

the radiographs are automatically received by BoneView 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

Once received by BoneView, the radiographs are automatically processed by the AI algorithm

to identify regions of interest. Based on the processing result, BoneView 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 does not alter

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

Once available, the result files are sent by BoneView 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 necessarily identical.

and highlight fractures during the review of radiographs.


High-sensitivity operating point
High-specificity operating point

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


High-sensitivity operating point
DOUBT FRACT

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

operating point and high-specificity operating point on the merged datasets


Anatomical Specif
icity –
95%
Sen
sitivity
–
Specificity – 95%
Sensi
tivity
–

Areas of Clopp
er-Pea
rson
95%
Clopp
er-
Clopper-Pearson 9
5% C
loppe
r

Interest
CI
Pe
arson C
I
CI
Pear
son C
I

5
avenue
du Généra
l de Ga
ulle, 941
60 Saint-
Mandé - FRANCE

SAS au
capital de
115 37
2 euros –
RCS Crét
eil 834 105 470

SIR
ET : 834 1
05 470
00027 – a
dmin@g
leamer.ai

Anatomical Specificity – 95% Sensitivity – Specificity – 95% Sensitivity –


Anatomical
Specificity – 95%
Sensitivity –
Specificity – 95%
Sensitivity –

Areas of
Clopper-Pearson
95% Clopper-
Clopper-Pearson
95% Clopper-


(Predicate Device)
(Subject Device)
Substantial

Separate interventional tools
workstation

Different.
Designation adjustment
only.
We have reclarified the qual-
ification of hardware versus
software. By definition,
here, the hardware (Endo-
Naut Workstation) is an ac-
cessory to the software med-
ical device. To better differ-
entiate what is applicable to
one and the other, we have
identified the software by
“EndoNaut Software” and
the hardware by “EndoNaut
Workstation”. The Endo-
Naut Workstation alone is
not subject to any regulatory
submission. It is integrated
with the System submitted
for FDA approval under the
name, EndoNaut.

Different
Change of the Panel PC, the
Control Panel model and Ca-
blings.
Due to these changes, the
Product number
“TS1CA2DS1-2” has been
changed. New testings have
been performed.

Identical
EndoSize Software is an ac-
cessory that is intended to
supplement the performance
of EndoNaut.

Trade name: EndoNaut
Common name: EndoNaut
System
UDI-DI: 3760262480046

Different
No risk related to idenfica-
tion between older and
newer EndoNaut device.
EndoNaut is now referring to
the EndoNaut System while
the EndoNaut Software is
named EndoNaut Software.


No unit of the predicate de-
vice was sold in the USA.

Manufacturer
Therenva SAS
Therenva SAS
Identical

Interventional Fluoroscopic
X-Ray System

Software Safety class (62304)
B
B
Identical

Level of concern
Moderate
Moderate
Identical

Intended use and indications
for use were mixed.
See below Indications for
use.

Different
A distinction between "In-
tended use" and "indications
for use" has been made based
on the recommendations of
the FDA Guidance " The
510(k) Program: Evaluating
Substantial Equivalence in
Premarket Notifications
[510(k)]” (section IV, D, 1).

EndoNaut provides image
guidance by overlaying pre-
operative 3D vessel anatomy
onto live fluoroscopic im-
ages in order to assist in the
positioning of the guide-
wires, catheters and other
endovascular devices.
EndoNaut is intended to as-
sist endovascular procedures
in the thorax, abdomen,
neck, pelvis and lower limbs.
Suitable procedures include
(but not limited to) endovas-
cular aortic aneurysm repair
(AAA and TAA), angio-
plasty, stenting and emboli-
zation in iliac arteries and
corresponding veins.
EndoNaut is not intended for
use in the X-ray guided pro-
cedures in the liver, kidneys
or pelvic organs.

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 corresponding
veins.
EndoNaut is indicated for
endovascular procedures in
the thorax, abdomen, pelvis
and lower limbs.


(Predicate Device)
(Subject Device)
Substantial

1 label in the “about” section
for the Medical Device Soft-
ware with the Trade Name
“EndoNaut”
+
1 label for the Separate inter-
ventional tools workstation
with the Trade Name “Endo-
Naut” and Product Number
= TS1CA2DS1-1 + unique
Serial (production) Number

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)

Different
Each component of the En-
doNaut System has its
proper labelling.
Complete review of Label-
ling design. Use of symbols
of ISO 15223-1.
Addition of UDI.
Identical
The system has a unique
identifier (S/N).

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.

Different
The directions for use have
been enhanced to clearly dis-
tinguish the instructions spe-
cific to the medical device
Software, “EndoNaut SW”
from the instructions specific
to the EndoNaut Work-
station, accessory to Endo-
Naut SW.

Software only product; runs
on a separate interventional
tools (imaging) workstation.

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.

Different
EndoNaut (legacy device)
was intended to be sold with
and installed on the separate
interventional tools work-
station (ref: TS1CA2DS1-1)
or installed on any hardware
meeting the minimum re-
quirements.
The conditions for installing
the software on the work-
station are identical.
Only the model number of
the workstation has changed
(ref: TS1CA2DS1-2).

Different
Support for Windows 7
ended on January 14, 2020.


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

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

Similar
Some clarifications are
made.
Preoperative data is a man-
datory input for the use of AI
module, but it is not for the
PAD module.
Preoperative data include
pre-op CT images and sizing
report (in case of AI module
use).
The stent placement strategy
and sizing are usually per-
formed pre-operatively 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 user can import and
manage patient data within
the software. Patient data in-
clude pre-op CT images and
sizing report.

Similar
EndoNaut Software now en-
ables import and export of
data with a PACS.

Intra-operative fluoroscopy
or angiography, pre-opera-
tive CT scan image, pre-op-
erative 3D scanner volume
reconstruction (if any in case
of PAD module).
AI module only:
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.


(Predicate Device)
(Subject Device)
Substantial

AI 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).
Lower limbs module:
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.

AI 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).
PAD (lower limbs) module:
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 is
updated manually.

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

Different
Improvement of semi-auto-
matic registration (already
existing requirement). The
change does not significantly
affect the use of the device.
No new risks or possible er-
rors were detected or identi-
fied. New clinical data were
not necessary. V&V activi-
ties were performed and suc-
cessful. No additional ques-
tions raised for safety and ef-
fectiveness.

AI module:
Draw markers on intra-oper-
ative images, locate/track
points between per-op and
pre-op images, and take
measurements on pre-op CT
scan images and fusion
view.
Lower limbs module:
Draw lesions markers on
panorama (stenosis and

AI module:
Draw markers on intra-oper-
ative images, locate/track
points between per-op and
pre-op images, and take
measurements on pre-op CT
scan images and fusion
view.
PAD (lower limbs) module:
Draw lesions markers on
panorama (stenosis and


thrombosis), calibrate the
length of previous marked
lesions due to inserted mate-
rial, draw markers, create a
control panorama.

Energy emitted or absorbed
No
No
Identical

Panel PC Baaske, model e-
medic Silence TP 4
Rated AC 100-240V, 2.3-
0.8A 50-60Hz
Monitor size: 24’’ LCD
Brigthness: 250 cd/ m² typi-
cal
Resolution: 1920 x 1080
Cooling Fanless (no mainte-
nance)

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)

Different
No new risks or possible er-
rors were detected or identi-
fied. V&V activities were
performed and successful.
No additional questions
raised for safety and effec-
tiveness.

Workstation secondary dis-
play (touch screen)

One Touch monitor ELO,
model 1519LM,
rated AC 100-240V 1.2-
0.63A 60/50Hz
Monitor size: 15.6’’ LCD
Resolution: 1366 x 768
Brightness: 225 cd/m2
Touch technology: PCAP

One Touch monitor ELO
model 1502L,
rated AC 100-240 V
Input frequency: 50-60 Hz
Monitor size: 15.6’’ LCD
Resolution: 1920 x 1080
Brightness: 270 cd/m2
Touch technology: PCAP

Similar
New monitor provides
more effective visual image
resolution.
No new risks or possible er-
rors were detected or identi-
fied.

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

Height: 1742 mm
Width (footprint): 661 (640)
mm
Depth (footprint): 950 (660)
mm
Weight: 71 kg

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

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

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

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

Similar
Simply a new more common
video interface is now used.


(Predicate Device)
(Subject Device)
Substantial

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

Connection Box
Front cable RJ45
DVI front cable
BNC front cable
USB 3.0 front cable 1m
(x2)
Power supplies
Power supply extension jack
2.5mm 3m IEC extension
cable 1m (red)
IEC extension cable 0.5m
(blue)
External power sup-
ply ELO TOUCH
1519LM
External power sup-
ply Baaske
Video cabling: DVI 5m
Other cables:
DisplayPort DVI ca-
ble 1.5m
USB 3.0 A/B 1m
USB 2.0 2m

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

Similar
A newer DICOM Conform-
ance Statement has been
written for EndoNaut Sys-
tem Software and is pro-
vided in Appendix 2.

Conformity to IEC 60601-1
of the separate interventional
tools 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 the separate
interventional tools work-
station

Different
US deviations to IEC 60601-
1 are taken into account for
the new model of separate
interventional tools work-
station (TS1CA2DS1-2).

Conformity to IEC 60601-2
of the separate interventional
tools workstation

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 the separate interven-
tional tools workstation

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


Philips Healthcare (Suzhou) Co., Ltd.
No. 258, Zhongyuan Road, Suzhou Industrial Park,
Suzhou Jiangsu, CHINA, 215024
Establishment Registration Number: 3009529630

Primary Contact
Person:
Secondary Contact
Person

Shiguang An
Regulatory Affaires Engineer
Phone: +86-24-28206367
E-mail: shiguang.an@philips.com
Erhong Wang
Senior Manager Regulatory Affairs
Phone: +86-512-67336804
E-mail: ErHong.WANG@philips.com

Classification Regulation:
21CFR 892.1750

Philips Medical Systems
(Cleveland), Inc.


The Incisive CT is a Computed Tomography X-Ray System
intended to produce images of the head and body by
computer reconstruction of x-ray transmission data taken at
different angles and planes. These devices may include
signal analysis and display equipment, patient and
equipment supports, components and accessories. The
Incisive CT is indicated for head, whole body, cardiac and
vascular X-ray Computed Tomography applications in
patients of all ages.
These scanners are intended to be used for diagnostic
imaging and for low dose CT lung cancer screening for the
early detection of lung nodules that may represent cancer*.
The screening must be performed within the established
inclusion criteria of programs / protocols that have been
approved and published by either a governmental body or
professional medical society.
*Please refer to clinical literature, including the results of the
National Lung Screening Trial (N Engl J Med 2011;
365:395-409) and subsequent literature, for further
information.

The proposed Philips Incisive CT is advanced continuous-
rotation computed tomography systems suitable for a wide
range of computed tomographic (CT) applications.
The proposed Philips Incisive CT is used clinically as a
diagnostic patient imaging device that produces images that
correspond to tissue density. The quality of the images
depends on the level and amount of X-ray energy delivered
to the tissue. CT imaging displays both high-density tissue,
such as bone, and soft tissue.
The principal technological components (rotating x-ray tube,
detector and gantry) of the proposed Philips Incisive CT
substantially equivalent to the currently marketed predicate
device Philips Ingenuity CT (K160743, 08/08/2016)
Based on the information provided above, the proposed
Philips Incisive CT does not raise different questions of
safety and effectiveness compare to the currently marketed
predicate device Philips Ingenuity CT (K160743,
08/08/2016).


The test results demonstrate that the proposed Philips
Incisive CT meets the acceptance criteria and is adequate
for its intended use. Additionally, the risk management
activities show that all risks are sufficiently mitigated, that no
new risks are introduced, and that the overall residual risks
are acceptable.

The proposed Philips Incisive CT did not require clinical
study since substantial equivalence to the legally marketed
predicate device was proven with the verification/validation
testing.


Identical.
Therefore, substantially
equivalent.

The proposed Philips
Incisive CT rotation
speed faster than
Ingenuity CT to meet
the wider heart rate
application.
Safety and
effectiveness are not
affected.
Therefore,
demonstrating
substantial
equivalence.


High resolution mode:
16 lp/cm
Standard resolution
mode: 13 lp/cm

High resolution mode:16
lp/cm
Standard resolution mode:
13 lp/cm

Identical.
Therefore, substantially
equivalent.

0.27% at 120 kV, 230
mAs, 10 mm slice
thickness

0.27% at 120 kV, 250
mAs, 10 mm slice
thickness

Helical: 0.67mm – 5mm
Axial: 0.625mm –
10.0mm

Helical: 0.67mm – 5mm
Axial: 0.625mm – 12.5mm

Essentially the same
slice thickness, does
not affect safety and
effectiveness.
Therefore,
demonstrating
substantial
equivalence.

The proposed Philips
Incisive CT provide
higher resolution than
Ingenuity CT.
Safety and
effectiveness are not
affected.
Therefore,
demonstrating
substantial
equivalence.


Same supplier, same
technology and similar
function.
Therefore, substantially
equivalent.

Compliance with NEMA
XR25 , XR28 and XR29

Compliance with more
NEMA standard.
Safety and
effectiveness are not
affected.
Therefore,
demonstrating
substantial
equivalence.


Secondary
Predicate
Device Philips
Incisive
CT(K180015)

Conclusion
(Function/ User
interface/
Workflow)

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

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

The volume mode is used to display CT
scanner data in a full volume image. It


provides basic tools for image editing and
generation of cine movies.

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

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

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

Dose-Modulation is a scanner function
which modulates the tube current in two
ways (angular and longitudinal modulation)
simultaneously.

Use the on line MPR mode to view three-
plane orthogonal images. In this mode, the
three shown planes can be easily
correlated.

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

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

This feature enable the usage of the injector
scan trigger.

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

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


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

Continuous CT (CCT) is a scanning mode
that allows the physician to perform
extended, low-dose scans while performing
a biopsy.
The resulting images display on a remote
monitor in the scan room, providing visual
feedback during the biopsy.

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

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

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

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

Axial
Prospective
Gating
calcium
scoring

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


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

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

Precise image reconstruction is a recon
mode where the system uses a
trained deep learning neural network to
generate noise reduction images
and improve low contrast detectability
with reduced dose compared with
standard FBP recon mode.

Different:
safety and
effectiveness
refer to
K210760 for
Precise Image

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

Different:
safety and
effectiveness
refer to
K203020 for
Precise Cardiac

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

Different:
Safety and
effectiveness
refer to
K203514 for
Precise Position

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

Different: Precise
intervention is a
function that
support user to
view the
distance, angle
between the
injector and the
object, system
validation report
proved that


there is no
impact on
system safety
and effectiveness

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

Different: Direct
result is
workflow
enhancement to
make user direct
get derived
image after
acquisition no
impact on
system safety
and effectiveness

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

The Parallel
workflow of
Incisive CT is the
workflow
update, no
impact safety
and
effectiveness.


Supplementary Imaging features Comparison

Conclusion
(Function/ User
interface/
Workflow)

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

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


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

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

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

Spin / Spin scan mode
Dual energy Viewer is an application for
review and analysis of CT dual-energy
scans. User need to load CT dual-energy
scan data which is two series with similar
KV. It provides registration function and can
generate different weighted KV images.
User can use the tools to separate
materials.


Bulbeck Mill
Barrington
Cambridgeshire
CB22 7QY
UK


Business Name
Emergo Global Representation LLC

2500 Bee Cave Road
Bldg 1, Suite 300
Austin, TX 78746
United States


Cydar EV Also referred to as Cydar EV Series B, Cydar EV Maps

OWB, Interventional Fluoroscopic X-Ray System

next version number will be assigned to the first release of that device.


CT import, intra-operative overlay, post-operative review

Measurements and segmentation on CT scans


Cydar EV Series B
Cydar Medical Ltd
Device under
assessment

Cydar EV Series A
Cydar Medical Ltd
Primary Equivalent Device
K160088

EndoSize
Therenva
Secondary Equivalent
Device
K141475

Identified differences or
conclusion of no difference

targeted anatomy is clarified in Cydar EV Series B. See section (add Section references)in this summary.


Cydar EV provides tools
to:
• Import and visualise CT
data
• Segment and annotate
vascular anatomy from
CT data
• Place and edit virtual
guidewires and
measure lengths on
them
• Make measurements of
anatomical structures
on planar sections of
the CT data
• Produce an operative
plan from
measurements and
segmentation of
preoperative vessel
anatomy
• Overlay planning
information such as
preoperative vessel
anatomy onto live
fluoroscopic images,
aligned based on the
position of anatomical
features present in both
• Non-rigidly transform
the visualisation of
anatomy when intra-
operative vessel
deformation is
observed
• Post-operatively review
data relating to
procedures where the
system was used

Cydar EV is intended to
display combined live 2D X-
ray fluoroscopy and 3D
anatomy for image guidance
during surgery.
Features of the device
include:
Import and visualise CT scan
data.
Segment and annotate
vascular anatomy from CT
data.
Produce an operative plan
Overlay planning
information such
as preoperative vessel
anatomy onto live
fluoroscopic images, aligned
based on the position of
anatomical features present
in the fluoroscopic images.
Non-rigidly transform the
visualisation of anatomy
when intra-operative vessel
deformation is observed.

EndoSize is a software
solution that is intended
to provide Physicians and
Clinical Specialists with
additional information to
assist them in reading and
interpreting DICOM CT
scan images of structures
of the heart and vessels.
EndoSize enables the user
to visualize and measure
(diameters, lengths,
volumes, angles)
structures of the heart
and vessels.

Conclusion: Cydar EV Series B
is similar intended use to the
primary predicate device
differing only in additional
features; placement and
editing virtual guidewires,
measurement of lengths and
measurement of anatomical
structures on planar sections
of CT data is similar to the
secondary predicate device.
Measurement accuracy
verification testing and
summative user study is
performed as part of the
design and development
process

Cydar Ltd 510(k) Submission: Cydar EV Series B


Cydar EV is intended to
assist fluoroscopic X-ray
guided endovascular
procedures in the chest,
abdomen, and pelvis by
presenting the operative
plan in the context of
intraoperative
fluoroscopy.
Cydar EV is intended to be
used for patients
undergoing a fluoroscopic
X-ray guided endovascular
surgery in the chest
abdomen and pelvis, and
who have had a pre-
operative CT-scan.
The performance of the
Cydar EV software in the
presence of immature
vertebral anatomy is
unknown. The
Instructions for Use
explicitly state this
uncertainty and that the
software is therefore not
recommended for use in
patients under the age of
18.
IMPORTANT: Pre-
Operative Maps show
static anatomy derived
from the pre-operative
CT. Real-time anatomy
moves with the
cardiorespiratory cycle;
progressive disease may
cause the anatomy to
change over time; and stiff
wires, stents or other
surgical instruments, may
straighten and displace
blood vessels from the
pre-operative position
It is therefore
mandatory to check the
real-time anatomy with
a suitable imaging
technique, such as
contrast angiography,
before deploying any
invasive medical device.

Cydar EV provides image
guidance by overlaying
preoperative 3D vessel
anatomy from a previously
acquired contrast-
enhanced, diagnostic CT
scan onto live X-ray
fluoroscopy images in order
to assist in the positioning of
guidewires, catheters and
other endovascular devices.
Cydar EV is intended to
assist X-ray fluoroscopy-
guided endovascular
procedures in the lower
thorax, abdomen and pelvis.
Suitable procedures include
endovascular aortic
aneurysm repair,
angioplasty, stenting and
embolization in the
common iliac, proximal
external iliac and proximal
internal iliac arteries and
corresponding veins.
Cydar EV is not intended for
use in X-ray guided
procedures in the liver,
kidneys or pelvic organs.

Therenva Endosize
enables visualization and
measurement of
structures of the heart
and vessels for pre-
operational planning and
sizing for cardiovascular
interventions and surgery
General functionalities
are provided such as:
• Segmentation of
cardiovascular
structures
• Automatic and manual
centreline detection
• Visualisation of CT scan
images in every planes,
2D review, 3D
reconstruction, Volume
Rendering, MPR,
Stretched CMPR
• Measurement and
annotation tools
• Reporting tools

Conclusion: Changes in
wording clarifying target
anatomy between Cydar EV
Series B and primary predicate
are detailed in the section
beneath this table. Other
differences these statements
includes clarifications for the
following which are present
and equivalent in both
devices:
Adjustment in anatomy to
have the option to non-rigidly
transform the visualisation of
the anatomy in the Map
Statement clarifies device has
not been tested on under 18's
immature vertebral anatomy.
Cydar EV series B allows
preoperative and
intraoperative imaging,
Endosize allows preoperative
imaging only.Other differences
between Cydar EV Series B and
primary predicate are as
detailed in the section beneath
this table, the additional
features: placement and
editing virtual guidewires,
measurement of lengths and
measurement of anatomical
structures on planar sections
of CT data. Measurement
accuracy verification testing
and summative user study is
performed as part of the
design and development
process.


Classification
Product code /
regulation

OWB; Interventional
Fluoroscopic X-Ray
System: Regulation:
892.1660

OWB; Interventional
Fluoroscopic X-Ray System
Regulation Regulation:
892.1660

LLZ ; System image
processing radiology
Regulation: 892.2050

OWB sufficiently covers the
intended use of Cydar EV.

Construction
Software product
Software product
Software Product
No difference

Preoperative planning:
Import and visualise CT
data; Segment and
annotate vascular
anatomy from CT data;
Place and edit virtual
guidewires and measure
lengths on them; Make
measurements of
anatomical structures on
planar sections of the CT
data; Visualise the
segmented vascular
anatomy, annotations +/-
measurements together
(the ‘Operative Plan’)
Intra-operative (Fusion
imaging functions):
Overlay planning
information such as
preoperative vessel
anatomy onto live
fluoroscopic images,
aligned based on the
position of anatomical
features present in both;
Non-rigidly transform the
visualisation of anatomy
when intra-operative
vessel deformation is
observed
Post-operative (Review
functions): Post-
operatively review data
relating to procedures
where the system was
used

Preoperative planning:
Import and visualise CT
data; Segment and annotate
vascular anatomy from CT
data; Visualise the
segmented vascular
anatomy, annotations +/-
measurements together (the
‘Operative Plan’)
Intra-operative (Fusion
imaging functions: Overlay
planning information such
as preoperative vessel
anatomy onto live
fluoroscopic images, aligned
based on the position of
anatomical features present
in both; Non-rigidly
transform the visualisation
of anatomy when intra-
operative vessel
deformation is observed
Post-operative (Review
functions): Post-operatively
review data relating to
procedures where the
system was used

Preoperative planning:
Visualisation, annotations
and measurement
performed by clinicians
intended to provide
referring physicians with
clinically relevant
information for diagnosis,
surgery, and treatment
planning.

Conclusion: Difference
between Cydar EV Series B and
primary predicate are features;
place and edit virtual
guidewires and measure
lengths on them and make
measurements of anatomical
structures on planar sections
of the CT data
EndoSize is indicated for
preoperative planning only
Measurement accuracy
verification testing and
summative user study is
performed as part of the
design and development
process


Cydar EV Series B
Cydar Medical Ltd
Device under
assessment

Cydar EV Series A
Cydar Medical Ltd
Primary Equivalent Device
K160088

EndoSize
Therenva
Secondary Equivalent
Device
K141475

Identified differences or
conclusion of no difference

Cydar EV Series B device is
a software only medical
device that runs on a
standard computer that
meets the minimum
requirements. It can use
local DICOM files or
distant PACS server. The
device does not contact
the patient, nor does it
control any life sustaining
devices. The information
and measurements
displayed, exported or
printed are validated and
interpreted by Physicians.
EV Maps complies with
the DICOM voluntary
standards (ACR/NEMA
Digital Imaging and
Communication in
Medicine).

Cydar EV is a software only
medical device that runs on
a standard computer that
meets the minimum
requirements. It can use
local DICOM files or distant
PACS server. The device
does not contact the
patient, nor does it control
any life sustaining devices.
The information and
measurements displayed,
exported or printed are
validated and interpreted by
Physicians.
EV complies with the DICOM
voluntary standards (ACR/
NEMA Digital Imaging and
Communication in
Medicine).

EndoSize is a software-
only device that runs on a
standard computer that
meets the minimum
requirements. It can use
local DICOM files or
distant PACS server. The
device does not contact
the patient, nor does it
control any life sustaining
devices. The information
and measurements
displayed, exported or
printed are validated and
interpreted by Physicians.
EndoSize complies with
the DICOM voluntary
standards (ACR/NEMA
Digital Imaging and
Communication in
Medicine)

Conclusion: No difference to
design between Cydar EV
Series B and primary
predicate, this includes no
difference to algorithim or
development process.

Same clinical
condition or
purpose,
including
similar
severity and
stage of
disease

Cydar EV is intended only
to be used for patients
undergoing a fluoroscopic
X-ray guided endovascular
surgery in the chest,
abdomen, and pelvis, and
who have had a pre-
operative CT-scan.
The clinical procedures
indicated for the Cydar EV
devices are the same. For
these procedures a
clinical specialist will
determine the stage of
disease is advanced and
requires intervention.
Cydar EV devices are used
for guidance during the
procedure.

Cydar EV (Series A) is
intended to assist
fluoroscopy-guided
endovascular procedures in
the lower thorax, abdomen
and pelvis. Suitable
procedures include (but are
not limited to) endovascular
aortic aneurysm repair, (AAA
and mid-distal TAA),
stenting, and embolisation
in the common iliac,
proximal external iliac and
proximal internal iliac
arteries and their
corresponding veins. Cydar
EV (Series A) is not intended
for use in X-ray guided
procedures in the liver,
kidneys or pelvis organs.

Intended for patients who
require cardiovascular
interventions, EVAR,
TEVAR, TAVI and
Peripheral

Device is used indicated
for fluoroscopic X-ray
guided endovascular
procedures in the chest,
abdomen, and pelvis

Device is used indicated for
fluoroscopic X-ray guided
endovascular procedures in
the lower thorax,
abdomen, and pelvis

Device is used indicated
for heart and vessels

No significant difference. The
anatomy is clarified in this
document (add Section
references).


The target clinical users
for the Cydar EV Series B
device are experienced
medical practitioners
specialising in
endovascular surgery
(such as vascular
surgeons and
interventional
radiologists)
radiographers, and
specialist nurses. Other
users of the planning
functions may include
medical device company
representatives and
product specialists.

Physicians and clinical
specialists, users involved
in preoperative planning

Operating room, office
(during planning)

Operating room, office
(during procedure planning)

Conclusion: No significant
difference. Cydar EV Series B
and secondary predicate differ
slightly in intended clinical
environment as the predicate
is not intended for intra-
operative use.


GLS by AFI. Statistical analysis was done by Correlation, Bland-Altman:


The Logicon Caries Detector is a
software device that is an aid in the
diagnosis of caries that have
penetrated into the dentin, on
un-restored proximal surfaces of
secondary dentition through the
statistical analysis of digital
intra-oral radiographic imagery. The
device provides additional
information for the clinician to use
in his/her diagnosis of a tooth
surface suspected of being carious.
It is designed to work in conjunction
with an existing Carestream dental
RVG digital X-ray radiographic
system with dental imaging
software (dis) for Windows XP or
higher.

The Overjet Caries Assist (OCA) is a
radiological, automated, concurrent
read, computer-assisted detection
software intended to aid in the
detection and segmentation of caries
on bitewing radiographs. The device
provides additional information for
the dentist to use in their diagnosis of
a tooth surface suspected of being
carious. The device is not intended as
a replacement for a complete dentist's
review or their clinical judgment that
takes into account other relevant
information from the image, patient
history, and actual in vivo clinical
assessment.

Patients requiring dental services,
all sexes, no age restriction

Patients requiring dental services,
all sexes, at least 18 years of age,
and with permanent dentition.

Platform
Windows PC
Web - Edge, Chrome, Firefox

User Interface
Mouse, Keyboard
Mouse, Keyboard, Trackpad

Images can be scanned, loaded
from connected Carestream image
solutions

Images imported from the
radiographic device, or from the
practice management system, from
Carestream or Schick sensors

Image format
Carestream
jpg, png, eop, jif, dicom


The software provides graphical
representation of the density change
in a tooth, by looking for a pattern
of density dips starting at the tooth
surface, penetrating the enamel and
going into the dentin. Enamel is
represented by 10 green lines and
dentin by 5 blue lines. If a pattern
suggestive of caries exists, the dips
are highlighted with red dots to
warn the dentist.

Three layers:
- The Network layer works with the
practice PACS or EMR to transmit
the image and meta-data to Overjet.
- The decision layer processes the
image to ensure it is the correct data
type, and then annotates it via the
algorithm
- The presentation layer displays the
annotated image in a non-diagnostic
viewer. The dentist can filter,
display, hide, create and edit the
annotations presented.

Bitewing radiographs acquired
from Carestream dental RVG
digital X-ray radiographic
system

Digital files of Bitewing radiographs
whose longer edge is greater than 500
pixel resolution

● Outline of suspected region
● Tooth Density
● Lesion (caries) probability

Caries detection and segmentation
on radiograph resulting in outline of
suspected caries

Increase in dentist’s sensitivity of
approximately 20%

Increase in dentist’s sensitivity of
greater than 15%

Overjet Inc. Overjet Caries Assist Software: K212519


Standalone Performance of Overjet AI Algorithm based on Surfaces


Physical
Software Package
Software Package

Characteristics
Operates on off-the-shelf hardware
Operates on off-the-shelf hardware

Storage
Storage not supported
Storage not supported

Decision support device used to assist in

in the assessment and
the assessment and characterization of

breast lesions and thyroid nodules using US

Koios Decision Support (DS) is an artificial

intelligence (AI)/machine learning (ML)-

assist trained interpreting physicians
based computer-aided diagnosis (CADx)

in analyzing the breast ultrasound
software device intended for use as an

images of patients with soft tissue
adjunct to diagnostic ultrasound

breast lesions who are being referred
examinations of lesions suspicious for

for further diagnostic ultrasound
breast or thyroid cancer.

confirm regions of interest (ROIs) within an

learning-based decision support
image representing a single lesion or

nodule to be analyzed. The software then

automatically characterizes the selected

cancer.
image data to generate an AI/ML-derived

Koios DS for Breast automatically
applicable lexicon-based descriptors

classifies user-selected region(s) of
designed to improve overall diagnostic

interest (ROIs) containing a breast
accuracy as well as reduce interpreting

lesion into four BI-RADS-aligned
physician variability.

Koios DS software may also be used as an

displays a continuous graphical
image viewer of multi-modality digital

confidence level indicator of where
images, including ultrasound and

the lesion falls across all categories.
mammography. The software includes

tools that allow users to adjust, measure

classifies lesion shape and orientation
and document images, and output into a

according to BI-RADS descriptors.
structured report.

The software requires a user to select
Koios DS software is designed to assist

trained interpreting physicians in analyzing

the breast ultrasound images of adult (>=

22 years) female patients with soft tissue

breast lesions and/or thyroid ultrasounds

of all adult (>= 22 years) patients with

completed the prescribed training,
thyroid nodules suspicious for cancer.


When utilized by an interpreting physician
who has completed the prescribed
training, this device provides information
that may be useful in recommending
appropriate clinical management.

Target Population
(subset of above
for comparison
purposes)

Koios DS software is designed to assist
trained interpreting physicians in analyzing
the breast ultrasound images of adult (>=
22 years) female patients with soft tissue
breast lesions and/or thyroid ultrasounds
of all adult (>= 22 years) patients with
thyroid nodules suspicious for cancer.

Limitations for
Use
(subset of above
for comparison
purposes)

Limitations:
Koios DS for Breast is not to be used
on sites of post-surgical excision, or
images with doppler, elastography, or
other overlays present in them.
Koios DS for Breast is not intended for
the primary interpretation of digital
mammography images.
Koios DS for Breast is not intended for
use on mobile devices.

Koios DS for Breast is not to be used
• Patient management decisions should

not be made solely on the results of the

images with doppler, elastography, or
Koios DS analysis.

• Koios DS software is not to be used for

the evaluation of normal tissue, on sites of

Koios DS for Breast is not intended for
post-surgical excision, or images with

• Koios DS software is not intended for use

Koios DS for Breast is not intended for
on portable handheld devices (e.g.

use on mobile devices.
smartphones or tablets) or as a primary

descriptor, extra-thyroidal extension. In

the event that this condition is present, the


Modality Used for
Breast Ultrasound Data
Breast Ultrasound Data

Input
Input
Medical images provided in a DICOM
Medical images provided in a DICOM

The software requires a user to select
up to two ROIs, from up to two
orthogonal views, that represent a
single lesion to be selected and
processed.

orthogonal views, that represent a
two ROIs, from up to two orthogonal

Two ROIs that represent a single lesion to

be selected and processed are required for

The first ROI is drawn on the transverse

view of the nodule. The second is drawn on

Output (Breast)
Koios defined categorical and
Koios DS Breast defined categorical and

continuous outputs (confidence level
continuous outputs (confidence level

indicator) that align to BI-RADS, U1-U5, and

auto-classified shape and orientation
auto-classified shape and orientation.

Output (Thyroid)
Koios DS Thyroid software automatically

classifies thyroid nodules suspicious for

cancer based on image data generating an

ATA classification guidelines. The system

Foci) and a direct, image-derived cancer

risk assessment that is translated into an


Years of
Experience –
Mammography
and/or Breast
Ultrasound

Academic
Institution
Affiliation
(Yes/No)


R1
Domestic Endocrinologist (End)
< 10 years

R2
Domestic Radiologist (Rad)
≥ 20 years


Change in average Sensitivity and
Specificity of Follow-up with Koios DS
(US readers, US data)

Change in average Sensitivity and
Specificity of Follow-up with Koios DS
(EU readers, EU data)

Change in average AUC with Koios DS
(EU Readers, EU Data)

Inter-Reader Variability measuring the
association of TI-RADS points assigned
with and without decision support
Difference (Relative Change %)

40.7% (all readers, all data)
37.4% (US readers, US data)
49.7% (EU Readers, EU Data)

-23.6% (all readers, all data)
-22.7% (US readers, US data)
-32.4% (EU Readers, EU Data)

Change in average AUC with Koios DS
descriptor classifiers only (without AI
Adapter) (parametric)

Change in average AUC with Koios DS
descriptor classifiers only (without AI
Adapter) (non-parametric)

Change in average sensitivity and
specificity of FNA with Koios DS
descriptor classifiers only (without AI
Adapter)


Change in average sensitivity and
specificity of Follow-up with Koios DS
descriptor classifiers only (without AI
Adapter) – excluding cases
recommended for FNA

Change in average sensitivity and
specificity of Follow-up with Koios DS
descriptor classifiers only (without AI
Adapter) – including cases
recommended for FNA


All Readers, All Data
US Readers, US Data
EU Readers, EU Data

Change in average Sensitivity/Specificity of FNA

TI-RADS categorization
w/AI Adapter + size
criteria

Change in average Sensitivity/Specificity of Follow-up

Summary of System Clinical Performance Using TI-RADS RSS


Name of Device:
EFAI Intelligent Cardiothor

Classification Name:
Medical image management


Regulation Number
21 CFR §890.2050
21 CFR §890.2050
Same

Medical image
management and
processing system

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

The Imbio RV/LV Software device is designed to measure the maximal diameters
of the right and left ventricles of the heart from a volumetric CTPA acquisition
and report the ratio of those measurements. RV/LV analyzes cases using an
artificial intelligence algorithm to identify the location and measurements of the

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System


ventricles. The RV/LV software provides the user with annotated images showing
ventricular measurements. Its results are not intended to be used on a stand-alone
basis for clinical decision-making or otherwise preclude clinical assessment of
CTPA cases.

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

Non-gated, CT
Pulmonary
angiography images

Yes, there is difference.
The proposed device used
chest x-ray images in PA
view as input to identify
the maximal diameters of
the maximal transverse
diameter of heart and
maximal inner transverse
diameter of thoracic cavity.
The primary device used
CTPA images as input to
identify the maximal
diameters of the right and
left ventricles of the heart.
The verification report can
verify the difference does
not raise the impact of the
safety and effectiveness.
Both of the devices are in
DICOM images as input.

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

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

Similar.
The subject device is
intended to output the
maximal inner border
diameter of thoracic cavity


Computed
Tomography
Pulmonary
Angiography (CTPA)
images

Yes, there is a difference.
Despite two compared
devices is present with the
different imaging modality.
The verification &
validation result has shown
no impact raise in the
safety and effectiveness.

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

Yes, there is a difference.
The usability report can
verify the different
environment does not raise
the impact of safety and
effectiveness.

Software device that
operates on off-the-shelf
hardware

Software devices uses
software algorithms for
image

Diameter Measurement
Yes - Automated
Yes - Automated
Same

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

Saved in PDF and
DICOM compatible
format

They have same DICOM
format storage. The
storage of subject device in
JASON format has been
validated through the
system test. There is no
impact on safety or
effectiveness of the subject
device.


Subject Device:
Predicate Device: Micro
Comparison

Micro C Medical Imaging
C Medical Imaging

Regulation
21 CFR 892.1720
21 CFR 892.1720
Identical

Classification
Class 2
Class 2
Identical

The Micro C Medical
Imaging System, M01 is a
handheld and portable
general purpose X-ray
system that is indicated
for use by


by qualified/trained
clinicians on adult and
pediatric patients for
taking diagnostic static
and serial radiographic
exposures of
extremities.
The device is not
intended to replace a
radiographic system
that has both variable
tube current and
voltages (kVp) in the
range that may be
required for full
optimization of image
quality and radiation
exposure for different
exam types.

● Surgical applications
● Pediatric patients
● Fluoroscopy
● For cardiac and
vascular applications
● Mammography
● Dental applications
● Contact with non-
intact skin

Static, serial radiographic
and photographic images
for convenience.

Detector
6 x 6” digital detector
6 x 6” digital detector
Identical

The removable fixed
collimators (referred to
as pucks)

Weight
Emitter: 2.86kg (6.3lbs)
Emitter: 2.86kg (6.3lbs)
Identical

510(k) Summary Micro C Medical Imaging, M01


Cassette: 6.5kg (14.3lbs)
Control Unit: 8.6kg
(19.0lbs)

Emitter: 9.3”H x 3.5”W x
8.3”L (excluding SSD
Cone)
Cassette: 15.5”H x
15.5”W x 2.8”L
Control Unit: 16.4”H x
12.9”W x 5.5”L

20 cm SSD Cone ensures
minimum SSD of 20 cm

Virtual light field on
Monitor UI. No projected
light field.

120 VAC / 60 Hz (no
rechargeable battery)

Similar- The overall range is
identical. Single AiLARA
mode allows for ms values
throughout the range. Serial
AiLARA mode has a fixed
output of 33 ms.

Similar- The overall range is
identical. AiLARA allows for
kVp values throughout the
range.

Scintillator
Cesium Iodide (CsI)
Cesium Iodide (CsI)
Identical


Subject Device:
Predicate Device: Micro
Comparison

Micro C Medical Imaging
C Medical Imaging

User Interface can be
used to drag, zoom,
rotate and also adjust
brightness, contrast, and
sharpness.

● Cassette
● Control Unit
● Emitter
● Collimation Pucks
● SSD Cone
● Cassette Power
Cable
● Cassette Data Cable
● Control Unit Power
Cable
● Connector Covers
● Instructions for Use
● Case


AiLARA’s full development dataset was split into a training set (80% of
the data) and a testing set for algorithm verification (20% of the data)
per Good Machine Learning Practices as outlined in FDA’s Proposed
Regulatory Framework for Modifications to Artificial
intelligence/Machine Learning (AI/ML) Based Software as a Medical
Device (SaMD)(2019). AiLARA’s model was trained, and at the end of
every epoch, the full testing set was sent into the model and was
predicted to show the model’s performance on unseen data. The model
was able to learn the trend of the training dataset (truth). The mean
squared error of the training and verification testing datasets were
plotted, and the trend lines showed that the model had learned the
general trend present in the data. Both training and testing Mean
Squared Error and Mean Absolute Error showed that additional training
(epochs) would have no added benefit.

Software verification was performed to ensure the updated Micro C
software met system-level software requirements. Software outputs
met the expected result in all cases, with no anomalies found.

An image quality study validation dataset was collected after the
AiLARA algorithm was frozen, finalized, and transferred to the Micro C
device. This validation set was completely independent of the algorithm
training and verification testing set. The emitter can move freely in
space (not attached to the detector), therefore the validation images
were collected with independent inputs that the algorithm had not
seen previously. The independent inputs were achieved by taking
images of phantoms at different emitter orientations and angles
(geometries). The validation dataset included images taken from ankle,
elbow, hand, foot, knee, toe, and wrist phantoms; each phantom was
captured at multiple distinct SIDs that spanned the full device SID range
of 20 cm to 45 cm. Additionally, each phantom view/SID combination
was captured at multiple orientations. Once the validation images were
collected, the images were reviewed and rated by board certified
radiologists and an orthopedic surgeon. All images were determined to
be diagnostically and clinically relevant.

AiLARA technique and dose evaluation testing was performed to
evaluate AiLARA mode’s radiation outputs as compared to diagnostic
reference levels from literature, to ensure an acceptable amount of
radiation was delivered. Additionally, AiLARA’s dose outputs from the
auto-selected techniques were compared to the predicate device’s
manual mode dose outputs that result from the techniques
recommended in the Instructions for Use. Results showed that all
AiLARA dose values were below the established Diagnostic Reference

Table 5-3: Non-Clinical Performance Data


Levels (DRLs) and there was no statistical difference between AiLARA
and Manual mode calculated entrance skin exposure doses.

Radiation Dose Testing on
Small/Pediatric Anatomies

Testing was conducted to evaluate AiLARA’s radiation outputs for small
size extremity anatomies (representing low thicknesses seen for small
patients, especially pediatrics) as compared to diagnostic reference
levels from literature to ensure an acceptable amount of radiation was
delivered. This study also included recording dose outputs at different
Source to Image Distance (SID) and emitter orientation configurations
to ensure doses are consistently acceptable at various emitter
orientations and small anatomy thicknesses. Results showed that all
AiLARA dose values were below the established Diagnostic Reference
Levels (DRLs) for small size anatomies, and doses were similar among
captures for each orientation within the same target thickness and SID
category.

A usability evaluation was performed for the addition of the AiLARA
modes for single radiography and serial radiography (DDR) imaging to
ensure the Micro C Medical Imaging System, M01 has acceptable use-
related risks and effectiveness during use. The study included 15
participants who were licensed to perform x-ray procedures and had
previous experience operating x-ray devices. All the identified critical
use tasks were completed with a passing result by 100% of participants.
The usability evaluation was performed in accordance with IEC 62366-
1:2020, Medical devices - Part 1: Application of usability engineering to
medical devices and Guidance for Industry and FDA Staff – Applying
Human Factors and Usability Engineering to Medical Devices (2016).


Automated Radiological Image Processing Software

Medical image management and processing system


ClearRead+Confirm Image Processing System


Medical image management
and processing system
Formerly: Picture archiving
and communications system

Automated Radiological Image
Processing Software

Manufacturer
Riverain Technologies
Qure.ai Technologies

ClearRead+Confirm is
intended to generate an
enhanced, secondary digital
radiographic image of the
chest to facilitate
confirmation of line/tubes.
The enhanced AP or PA
image of the chest provides
improved visibility of lines
and tubes. The ClearRead
+Confirm image provides
adjunctive information and
is not a substitute for the
original PA/AP image. This
device is intended to be used
by trained professionals,
such as physicians,
radiologists, and technicians,
on patients with lines and
tubes and is not intended to
be used on pediatric
patients.

The qXR-BT device is intended to
generate a secondary digital chest X-
ray image that facilitates
confirmation of the position of a
breathing tube and an anatomical
landmark on adult chest X-rays. This
device is intended for use by licensed
physicians who are trained in the
evaluation of breathing tube
placement on chest X-rays. The qXR-
BT image provides adjunctive
information and is not a substitute
for the original PA/AP image.

Modality
Digital chest radiograph
Digital chest radiograph

Table 1: Comparison between qXR-BT and the Predicate Device


Secondary digital chest X-ray image
and other Multiple electronic reports
with localization information of
segmented structures

Physicians, radiologists and
technicians

No additional hardware;
standalone software device
that integrates with PACS
through DICOM protocols

qXR-BT is standalone software
deployed on-premise or on the
cloud, that integrates with PACS or
other hardware or software imaging
platforms, including digital
radiographic processing systems
through DICOM protocols

Comparison of Differences between qXR-BT and the predicate device

Various medically inserted
tubes, lines, tubes and wires

Medically inserted breathing tubes
(tracheal tubes) only

Internal algorithms used
for image processing and
the mechanism by which
the output is displayed to
the clinician

ClearRead+Confirm uses a
bone suppression
mechanism with overall
image enhancements to
improve the visibility of lines
and tubes and provides no
boxes or markings to the
user.

qXR-BT uses pre-trained
convolutional neural networks to
process the images, and the device
highlights the tip of the tube and the
carina using markings on the
secondary image.


Table 2: Overall Results of Accuracy Testing in mm


Philips EPIQ
Diagnostic Ultrasound
System

The intended use of Philips EPIQ series diagnostic ultrasound systems is
diagnostic ultrasound imaging and fluid flow analysis of the human body,
with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral
Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric,
Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular),
Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal
(Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ
(Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal,
Transvaginal, Lung.
The clinical environments where Philips EPIQ diagnostic ultrasound systems
can be used include clinics, hospitals, and clinical point-of-care for diagnosis
of patients.
When integrated with Philips EchoNavigator, the systems can assist the
interventionalist and surgeon with image guidance during treatment of
cardiovascular disease in which the procedure uses both live X-ray and live
echo guidance.
The systems are intended to be installed, used, and operated only in
accordance with the safety procedures and operating instructions given in the
product user information. Systems are to be operated only by appropriately
trained healthcare professionals for the purposes for which they were
designed. However, nothing stated in the user information reduces your
responsibility for sound clinical judgement and best clinical procedure.

Philips Affiniti
Diagnostic Ultrasound
System

The intended use of the Affiniti Series Diagnostic Ultrasound Systems is
diagnostic ultrasound imaging and fluid flow analysis of the human body
with the following Indications for Use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral
Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric,
Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac),
Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other:
Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid,
Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where the Affiniti Diagnostic Ultrasound Systems
can be used include Clinics, Hospitals, and clinical point-of-care for
diagnosis of patients.
The systems are intended to be installed, used, and operated only in
accordance with the safety procedures and operating instructions given in the
product user information. Systems are to be operated only by appropriately
trained healthcare professionals for the purposes for which they were
designed. However, nothing stated in the user information reduces your
responsibility for sound clinical judgment and best clinical procedure.


Common or Usual Name:
Image Processing System, Radiological

Automated Radiological Image Processing Software
Radiological Imaging Processing System


Subject Device: Autoplaque 3.0
(K212758)

Predicate Device: Autoplaque add-on
ORS Visual
(K122429)

Stand-alone software
Yes
No, ORS Visual add-on

Review of coronary vessels in 2D
MPR, curved MPR, and straightened
view.

2D measurement tools of vessel
diameter and contour

3D Imaging
Review of structures in 3D
Same

MPR with oblique slicing and
variable slab thickness

LD-NCP volume: low-
density noncalcified plaque
volume


NCP burden: noncalcified
plaque volume/analyzed
vessel volume

LD-NCP burden: low-
density noncalcified plaque
volume/analyzed vessel
volume

CP burden: calcified plaque
volume/analyzed vessel
volume

Total plaque burden: total
plaque volume/analyzed
vessel volume

Plaque composition NCP:
Noncalcified plaque
composition (NCP volume
/total plaque volume)

Plaque composition CP:
Calcified plaque composition
(CP volume/total plaque
volume)

Plaque composition LD-
NCP: low-density
noncalcified plaque
composition (LD-NCP
volume/ NCP volume)

Diameter stenosis: maximal
diameter stenosis, with
respect to proximal and
distal references

QCAD: Maximal diameter
stenosis, with respect to
proximal and distal
references

Remodeling index: ratio of
maximum vessel
area/proximal and distal
references

Area stenosis: maximum
area stenosis, with respect to
proximal and distal
references

Contrast density difference:
maximum difference in
contrast density over lesion
with respect to proximal

MLD: minimal luminal
dimeter over lesion


Subject Device: Autoplaque 3.0
(K212758)

Predicate Device: Autoplaque add-on
ORS Visual
(K122429)

Vessel profile: Area,
maximum diameter,
minimum diameter measured
from selected vessel cross
section

Lumen profile: Area,
maximum diameter,
minimum diameter measured
from selected lumen cross
section

Deep learning based, validated with
ground truth by clinician expert
readers, with full option to edit.

Algorithm based, validated with ground
truth by clinician expert readers, with full
option to edit.


Technological
Transpara
ProstatID
Rationale of no Change to

Device is utilized to assist radiologists in
assessment of breast abnormalities using full-
field digital mammography exams and digital
breast tomosynthesis exam.

ProstatID is utilized to assist
radiologists in assessment of
prostate abnormalities using MR
image data. Safety and
effectiveness are supported
through performance assessments.

Software automatically registers images.

Detects and marks locations suspicious of
lesions.

Decision Support by region scores with higher
scores indicating a higher level of suspicion

Features are synthesized by an artificial
intelligence algorithm into a single exam
score.

Device Neural Net was trained on a database
of reference normal tissues and abnormalities
with known ground truth.

ProstatID was trained on a database
with reference normal tissues and
abnormalities with known ground
truths; however, the detection
algorithm uses Random Forest vs.
Neural Nets

ProstatID does not include a
standalone graphical user interface.
Rather, ProstatID outputs are in
DICOM format and may be viewed on
DICOM- compliant image viewers.

Table 1: Technical comparison between the predicate device and ProstatID


Modality-Specific AUC
AUC
95% CI
p-value

Table 2: MRMC estimate of summary modality-specific trapezoidal area under the ROC curve (AUC).


and approval workflow. The segmentations are produced by pre-trained and locked models that are

based on deep artificial neural networks. To take the device into use, the user does not have to provide

any contouring atlases. The models have been trained with the order of hundreds of scans, depending

on the ROI in question. The MVision AI Segmentation device creates initial contours of pre-defined

structures of common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male

Pelvis, and Female Pelvis. Supported anatomical sites and ROI listing of the organs for which the device

creates initial contours for, are listed below:


Otawara‐shi, Tochigi‐ken, Japan 324‐8550

Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound

Ultrasonic Pulsed Doppler Imaging System – Product Code:

Ultrasonic Pulsed Echo Imaging System – Product Code: 90

Diagnostic Ultrasonic Transducer – Product Code: 90‐ITX [p


Product
Marketed by
510(k) Number
Clearance Date

Aplio a550, Aplio a450 and
Aplio a, Diagnostic Ultrasound
System, Software V5.1


Subject Device
Primary Predicate Device
Secondary Predicate Device
Comparison

AI-Rad Companion
(Pulmonary) VA13A
(K213096)

AI-Rad Companion
(Pulmonary) VA10A
(K183271)

syngo.CT Extended
Functionality VB51
(K203699)

Creation of a lung
segmentation mask by
combining the segmentation
masks of 5 lung lobes.

The same algorithm as cleared with
the predicate devices is used.
Additional training data was added
as compared to the primary predicate
for the Pulmonary Density Feature.
This same data and method were
used with the secondary predicate
device (K203699).

Computation of segmentation
masks of the five lung lobes
(right upper (RUL), right
middle (RML), right lower
(RLL), left upper (LUL) and left
lower (LLL) lobe) for a given
CT data set of the chest.

AI-based identification of
areas with elevated
Hounsfield values. Threshold-
based identification of
highest elevated Hounsfield
values inside these elevated
regions, by a predefined
threshold of -200 HU.

The Opacity Detection is the same as
the secondary predicate devices
syngo.CT Extended Functionality
(K203699).

Lung lesion, lung
parenchyma, and pulmonary
density measurements.

Lung lesion, and lung
parenchyma measurements.

Extended with Pulmonary Density
results, as cleared in the secondary
predicate device (syngo.CT Extended
Functionality (K203699).


The parenchyma evaluation
uses the lobe mask, counts all
voxels per lobe, counts image
voxels below -950 HU, and
calculates the percentages of
these voxels relative to the
total number of voxels.
Additionally, it sums the
individual lobe results and
calculates the percentage for
the complete lung.

Same as the primary predicate device
AI-Rad Companion (Pulmonary)
VA10A (K183271).

The percentages are likewise
dedicated to the 4 ranges.
Name of ranges and their
ranges are configurable by
the user.

Visualization of Segmentation and Parenchyma Results

Color overlay of MPR and VRT
with evaluation results.

The external device syngo.CT
LungCAD is connected.

Based on the positions
provided via the LungCAD
Interface, a segmentation of
suspicious lung areas is
started. Within the derived
contours the maximum
diameter within one slice, the
3-dimensional diameter, and
the volume are determined.
The lesion is dedicated to a
lung lobe.
Additionally, the maximum
orthogonal 2D diameter is
measured and the mean from
maximum 2D diameter and
maximum orthogonal 2D
diameter is shown.

Based on positions provided
by the user, a segmentation
of suspicious lung areas is
started. Within the derived
contours the maximum
diameter within one slice, the
3-dimensional diameter, and
the volume are determined.
The lesion is dedicated to a
lung lobe.
Additionally, the maximum
orthogonal 2D diameter is
measured and the mean from
maximum 2D diameter and
maximum orthogonal 2D
diameter is shown.

The Bi-directional lesion diameter is
the same as the secondary predicate
device syngo.CT Extended
Functionality VB51 (K203699).


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

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

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 62366-1:2015

covering electrical and mechanical safety listed below:


Regulation Number
21 CFR 892.2050
21 CFR 892.2050
Same

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

Label/labeling
Conform with 21CFR Part 801
Conform with 21CFR Part 801
Same

Algorithm
Deep Learning
Deep Learning
Same

Segmentation of
Organ at Risk in the
Anatomic Regions

No Limitation on scanner model,
DICOM 3.0 compliance required

No limitation on TPS model,
DICOM 3.0 compliance required

Adults Only (greater than 21 years
of age)

Any patient type for whom
Relevant multimodality images
and segment (noncontrast) CT
images are available.

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

Limited to patients previously
selected for Radiation Therapy.
However, RT-Mind-AI can be used
for treatment evaluation and
treatment adaptation.

Limited to patients previously
selected for Radiation Therapy.
However, AccuContour can be
used for treatment evaluation and
treatment adaptation.

Table 1 Comparison of Technology Characteristics


RT-Mind-AI automatically
processes input image data

AccuContour automatically
processes input image data

Contour
visualization and
editing feature

RT-Mind-AI provides basic result
preview of automatic segmentation
results. Manual segment is
possible.

AccuContour provides basic result
preview of automatic segmentation
results. Manual segment is
possible.

The segmentation performance
was validated using datasets from
the USA using three major vendors
(GE, Siemens and Phillips). The
segmentation accuracy is evaluated
using DICE coefficient.

The segmentation performance
was validated using datasets from
China and the USA using three
major vendors (GE, Siemens and
Phillips). The segmentation
accuracy is evaluated using DICE
coefficient.

User Interface –
Results Preview
(Confirmation)

Basic result preview of automatic
segmentation results. Manual
segment is possible.

Design to be used by trained
clinicians.


Perfusion can be used by physicians to
aid in the selection of acute stroke
patients (with known occlusion of the
intracranial internal carotid artery or
proximal middle cerebral artery)
Instructions for the use of contrast agents
for this indication can be found in
Appendix A of the User’s Manual.
Additional information for safe and
effective drug use is available in the
product-specific iodinated CT and
gadolinium-based MR contrast drug
labeling.
In addition to the Rapid imaging criteria,
patients must meet the clinical
requirements for thrombectomy, as
assessed by the physician, and have none
of the following contraindications or
exclusions.
Contraindications/Exclusions:
• Bolus Quality: absent or
inadequate bolus.
• Patient Motion: excessive motion
leading to artifacts that make the
scan technically inadequate
• Presence of Hemorrhage

parameters related to tissue flow
(perfusion) and tissue blood volume.
Rapid CT-Perfusion and Rapid MR-
Perfusion can be used by physicians to aid in
the selection of acute stroke patients (with
known occlusion of the intracranial internal
carotid artery or proximal middle cerebral
artery)
Instructions for the use of contrast agents for
this indication can be found in Appendix A
of the User’s Manual. Additional
information for safe and effective drug use is
available in the product-specific iodinated
CT and gadolinium-based MR contrast drug
labeling.
In addition to the Rapid imaging criteria,
patients must meet the clinical requirements
for thrombectomy, as assessed by the
physician, and have none of the following
contraindications or exclusions.
Contraindications/Exclusions:
• Bolus Quality: absent or inadequate
bolus.
• Patient Motion: excessive motion
leading to artifacts that make the
scan technically inadequate
• Presence of hemorrhage

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

Standard off-the-shelf Hardware: On-
Premise and Secure Cloud

Mixed Traditional and AI/ML(NCCT
Motion Filter)


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

Computed Tomography (CT) via
DICOM Format

Magnetic Image Resonance (MRI) via
DICOM Format

MRI
Diffusion Weighted Image (DWI)
Not supported
Supported

Dynamic Analysis tissue flow
(perfusion) and tissue blood volume

CT
CT Perfusion (CTP)
Not supported
Supported

CTA-large vessel density analysis
Not Supported
Supported

Diffusion MRI
Isotropic DWI (isoDWI)
Not supported
Supported

Trace of diffusion tensor (Trace)
Not supported
Supported

Cerebral blood volume (CBV)
Not supported
Supported

Mean transit time (MTT)
Not supported
Supported

Tissue residue function time to peak
(Tmax)

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

Motion correction
Not supported
Supported

Export perfusion and diffusion files to
PACS and DICOM file systems


Acquire, transmit, process, and store
medical images

Selection of Patients meeting criteria
for Thrombectomy

NCCT
Hyperdensity (Not included)
Supported
Supported

Hypodensity (Not included)
Not supported
Supported

Motion Artifact Filter (Not included)
Not supported
Supported


DHT8B: Division of Radiological Imaging Devices and

Office of Product Evaluation and Quality


Manufacturer
Formus Labs Ltd.
Peek Health, S.A.

Regulation Number
21 CFR 892.2050
21 CFR 892.2050

Formus Hip is a preoperative surgical
planning software. It is
intended to assist qualified medical
professionals in the preoperative
planning of orthopedic surgical
procedures.

PeekMed is a preoperative
planning software for surgery

Formus Hip is a pre-operative planning
software for orthopedic surgery. The
standalone software application imports
patient diagnostic imaging studies (e.g.
pre-dimensioned CT scans) from
PACS-systems or other conventional
medias. The Formus Hip system
contains an integrated database of
orthopedic hip implant geometries that
can be overlayed to assist surgeons in
their planning of orthopedic hip
surgeries. The software application
further enables the healthcare
professional to customize their
preoperative planning by means of an
interactive graphical user interface.
Finalized plans can be printed to a PDF
report. The qualified healthcare
professional can digitally perform the
surgical planning and also make it
available as a printable report. Clinical
judgment and experience with the
software are required for its successful
use.

PeekMed is a software system
designed to help surgeons’
specialists carry out the preoperative
planning in a prompt and efficient
manner for several surgical
procedures, based on their patients’
imaging studies. The software imports
diagnostics imaging studies such as x-
rays, CT or magnetic resonance image
(MRI). The import process can retrieve
files from a CD ROM, a local folder or
the PACS. In parallel, there is a
database of digital representations
related to prosthetic materials supplied
by their producing companies.
PeekMed allows health professional to
digitally perform the surgical planning
without adding any additional steps to
that process. This software system
requires no imaging study acquisition
specification (no protocol). Experience
in usage and a clinical assessment are
necessary for a proper use of the
software.

marketed predicate device (PeekMed, K182464).


Patient Population
Adults (≥ 21 years)
Adults and pediatrics

End Users
Qualified medical professionals
Surgeons

Computer
Personal computer or workstation
Personal computer or workstation

Operating System
Windows with a Chrome browser
Windows or OS X

Can be accessed from the Chrome
internet browser launched from a
standalone PC or workstation with
internet access.

It can be set to start from a workstation
or standalone for planning procedures.

Receive digital images from various
sources (including PACS system)

The software processes pre-
dimensioned CT imaging to produce
digital representations of the patient
anatomy to which digital
representations of prosthetic
components are overlapped.

The software processes data in
order to provide an overlap and
dimensioning of digital representations
of the prosthetic material

Allows the overlap of the digital
representation of prosthetic
components

Allows the overlap of models and the
intersection of the models

Hip, Knee, Spine, Upper Limb, Foot-
and-Ankle, Trauma

Total Hip Arthroplasty
(Additional joint replacements and
associated procedures specific to
product intended for expanded
indications)


The average Dice score must be equal
or greater than 0.9

The average MAD must be equal or
less than 2 mm

The average HD must be equal or less
than 5 mm in the femoral head and
acetabulum

3D models of the proximal
shaft inner cortical surface

3D models generated from
statistical shape modelling

acceptance criteria were met, as shown in the table below.


Characteristic
Subject Device
Predicate Device

Quantification of cardiovascular
function from an echocardiogram

Quantification and reporting of
results of cardiovascular function
to support physician diagnosis.
EchoGo Core is indicated for use
in adult populations

Anatomical site
Identical
Cardiovascular structures

Accredited echocardiographers
and sonographers at Ultromics

A comparison of technological differences between the subject and predicate devices follows.


• Technical QC
• Auto-View Classification
• Manual Labelling UI
• Contour Selection and
Approval
• Metrics Calculation
• Auditing
• Service Webhooks
• Reporting

• Technical QC
• Manual Labelling UI
• Contour Selection and
Approval
• Metrics Calculation
• Auditing
• Reporting

Strain temporal intensity
plot/CAMM plot

Contours overlayed on
echocardiogram images

Non-Simpson’s bi-plane LV
volume calculation methods

EF results shown with video clip
Yes
Yes

Manual editing of automated
result by user

Complies with IEC 62304:2015
and developed under an FDA QSR

Complies with IEC 62304:2006
and developed under an FDA QSR


compliant QMS incorporating risk
management per ISO 14971:2019

compliant QMS incorporating risk
management per ISO
14971:2007

Complies with IEC 62366-1:2020
and general use of FDA guidance
on usability engineering

General use of FDA guidance on
usability engineering

Equivalent to reference
comparator TomTec Arena TTA2
(K150122)


ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices

IEC 62304:2015 – Medical Device Software – Software Life Cycle Processes

IEC 62366-1:2020 – Medical Devices – Application of Usability Engineering to Medical

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

IEC ISO 10918-1:1994 – Digital Compression and Coding of Continuous-tone Still Images

The following consensus standards were used in the design and manufacture of EchoGo Core 2.0.


Left Ventricular Metric
% Root Mean Square Error

Volume at End Diastole and End Systole
8.57 – 16.59

Systolic Segmental Longitudinal Strain
5.51 – 9.98


Classification Name:
Magnetic Resonance Diagnostic Device

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

Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction
Processing Unit for MR


System
Subject Device
Predicate Device
Reference Device
Reference Device

Vantage Orian 1.5T,
MRT-1550, V7.0 with
AiCE Reconstruction
Processing Unit for MR


Vantage Orian 1.5T,
MRT-1550, V7.0 with AiCE
Reconstruction Processing
Unit for MR

Maximum Slew Rate
155 [mT/m/ms]
200 [mT/m/ms]
155 [mT/m/ms]


Subject Device:
Vantage Fortian 1.5T, MRT-1550, V8.0

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

Allows screen access to 1st level
operating mode

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

Potential emergency
condition and means
provided for
shutdown

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


Manufacturer
Device Name
Application No.

Shanghai United Imaging
Intelligence Co., Ltd.


Viz ANEURYSM (Viz ANX) is a radiological
computer-assisted triage and notification
software device for analysis of CT images of the
head. The device is intended to assist hospital
networks and trained radiologists in workflow
triage by flagging and prioritizing studies with
suspected aneurysms during routine patient
care.

uAI EasyTriage-Rib is a radiological computer-
assisted triage and notification software device
for analysis of CT chest images. The device is
intended to assist hospital networks and trained
radiologists in workflow triage by flagging and
prioritizing trauma studies with suspected
positive findings of multiple (3 or more) acute rib
fracture(s).