Predicate Device
Aidoc Briefcase for ICH triage (K180647)

Subject Device
Aidoc Briefcase for ICH and PE triage

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

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

Non-contrast head CT scan and CTPA
(single energy exams only)

DICOM Information about the patient,
study and current image

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

Artificial intelligence algorithm with
database of images


Presentation of a small, compressed, black
and white preview image that is labeled
“Not for diagnostic use”;
The device operates in parallel with the
standard of care, which remains the default
option for all cases.


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

cmTriage is a passive notification
for prioritization-only, parallel-
workflow software tool used by
radiologists to prioritize specific
patients within the standard-of-care
image worklist for 2D FFDM
screening mammograms.
cmTriage uses an artificial
intelligence algorithm to analyze
2D FFDM screening mammograms
and flags those that are suggestive
of the presence of at least one
suspicious finding at the exam
level.
These flags are viewed by the
radiologist via their Picture
Archiving and Communication
System (PACS) worklist. The
decision to use cmTriage codes and
how to use cmTriage codes is
ultimately up to the radiologist.
cmTriage does not send a proactive
alert directly to the radiologist.
Radiologists are responsible for
reviewing each exam on a diagnostic
viewer according to the current
standard of care. cmTriage is limited to
the categorization of exams, does not
provide any diagnostic information
beyond triage and prioritization, does
not remove images from the
radiologist’s worklist, and should not
be used in lieu of full patient
evaluation, or relied upon to make or
confirm diagnosis.
cmTriage is for prescription use only.

Similar except to
anatomy, imaging
modality and lesion
type

Notification-only,
parallel workflow
tool


Identify patients
with prespecified
clinical condition

Different but are
“time sensitive
imaging” per 21CFR
892.2080

Independent of
standard of care
workflow

Different but both run
on “radiological
medical images” per
21 CFR 892.2080

Different anatomical
sites but both
“operates on
radiological images of
the human body” per
21 CFR 892.2080

Aids prompt
identification of
cases with
indicated findings


RSL-D-RS-8.1 Traditional 510(k) Submission RayStation 8.1


Radiological Computer-Assisted Triage and Notification
Software

The HealthICH device is substantially equivalent to the following device:


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

AccipioIx is a software
workflow tool designed to
aid in prioritizing the clinical
assessment of adult non-
contrast head CT cases with
features suggestive of acute
intracranial hemorrhage in
the acute care environment.
AccipioIx analyzes cases
using an artificial intelligence
algorithm to identify
suspected findings. It makes
case-level output available to
a PACS/workstation for
worklist prioritization or
triage.
AccipioIx is not intended to
direct attention to specific
portions of an image or to
anomalies other than acute
intracranial hemorrhage. Its
results are not intended to be
used on a stand-alone basis
for clinical decision-making
nor is it intended to rule out
hemorrhage or otherwise

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


preclude clinical assessment
of CT cases.

Notification-
only, parallel
workflow
tool

Prespecified clinical users
(clinicians)

Identify patients
with
prespecified
clinical
condition

Alert to finding
Yes; flagged for review
Yes; flagged for review
Same

Aids prompt
identification of
cases with
indicated
findings


CADx device used to
assist in the
assessment and
characterization of
breast abnormalities
using MR image data.

Decision support device
used to assist in the
assessment and
characterization of
breast lesions using US
image data.

Decision support
device used to assist in
the assessment and
characterization of soft
tissue breast lesions
using US image data.

Diagnostic Aid using
Machine Learning to
characterize image
features with user
provided ROIs to
generate a single
value relative to
reference
abnormalities (QI
Score).

Diagnostic Aid using
Machine Learning to
generate BI-RADS
shape and orientation
assessments coupled
with additional user
input BI-RADS
descriptors to generate a
preliminary BI-RADS
bucket assessment.

Diagnostic Aid using
Machine Learning to
characterize image
features with user
provided ROIs to
generate categorical
output that aligns to
BI-RADS and auto-
classified shape and
orientation.

High-risk screening;
diagnostic workup;
evaluation of known
disease

Any patient that has an
identified breast lesion
that is referred for
diagnostic ultrasound
examination; excludes
high-risk screening

Patients with soft
tissue breast lesions
who are being referred
for further diagnostic
ultrasound
examination.

Medical images
provided in a DICOM
format

“QI” score mapped
onto histograms of
distributions of
malignant and benign
lesions

BI-RADS bucket
assessment of lesions
based on auto-classified
shape and orientation
and user supplied inputs

Koios defined
categorical and
continuous outputs
(confidence level
indicator) that align to
BI-RADS and auto-
classified shape and
orientation

Software Package
Operates on off-the-
shelf hardware

Storage
Storage not supported
Storage not supported
Storage not supported


Criteria
Description
Subject Device
Predicate
Comparison

Different.
Predicate allows
for access via
Internet.

Different.
Predicate has
“image invert”
and “image
cine” features.


Capable of displaying
patient demographic
information

Data Security
Stored on server
Yes
Yes
Same

Audit Trail
Audit trail logged
Yes
Yes
Same

Database structure
allows mapping users
to groups internally or
mapping external
groups (AD, parent
application) to internal
groups and role

• JPEG for
Lossy
data
• PNG for
Lossless data

MPR Viewing
This viewing feature
Yes
Yes
Same

This viewing feature
enables the display of
3D perspective views
of CT and MR image
sets that have been
transformed into


volumes. It also
provides presets to
enable users to alter
the visualization
parameters
of the 3D views to
highlight features.

Active Target Tool
This viewing feature
Yes
Yes
Same

Crosshair
Navigation and
Synchronization

This viewing feature
provides a facility to
synchronize and scroll
through multiple
views at the same
time.

Ability to close an
image by clicking
an “X” in the
upper-left portion
of the view port

Ability to close an
image by clicking an
“X” in the upper-left
portion of the
viewport.

Ability to select locale
and language settings
on the login screen.

Ability to customize
the columns in the
study directory by
selecting the
dropdown arrow on
the right side of each
column.

Different.
Predicate has
feature to
customize the
view of the
directory.


Criteria
Description
Subject Device
Predicate
Comparison

Different.
Predicate has
feature to view
“help tips”.

Tablet
support for
information
purpose
only
(Not for diagnostic
use)

Different.
Predicate has
support for iOS
and Android for
non-diagnostic
viewing.

This viewing feature
provides access of
SurgicalAR software

Different.
Proposed device
has support for


on consumer, off-the-
shelf-wireless, Wi-Fi
enabled, stereoscopic
head-mounted display
with minimum of 2GB
RAM


101 Greenwich St, Suite 11C
New York, NY 10006


Common Name
System, Image Processing, Radiological

21 CFR 892.2050 Picture Archiving And Communications
System


Feature
Subject Device:
Predicate Device:

Cleerly Labs (K190868)
Autoplaque (K122429)

● Window Width/Level
● Zoom
● Pan
● Rotation
● Tracker

● Lumen Wall
● Vessel Wall
● Segment
● Stenosis
● Centerline
● Plaque
● Chronic Total Occlusion
(CTO)
● Stent
● Exclude
● Distance

● Lumen Wall
● Vessel Wall
● Segment
● Stenosis
● Centerline
● Plaque
● Exclude
● Distance

Table 3: Device Features Comparison Table


User-Modifiable
Thresholds:
● Non-Calcified Plaque
(NCP)
● Calcified Plaque (CP)
● Low-Density Non-
Calcified Plaque (LD-
NCP)

User-Modifiable
Thresholds:
● Non-Calcified Plaque (NCP)
● Calcified Plaque (CP)
● Low-Density Non-Calcified
Plaque (LD-NCP)

● Total Vessel
● Total Lumen
● Non-Calcified Plaque
(NCP)
● Low-Density Non-
Calcified Plaque (LD-
NCP)
● Calcified Plaque (CP)
● Total Plaque

● Total Vessel
● Non-Calcified Plaque (NCP)
● Low-Density Non-Calcified
Plaque (LD-NCP)
● Calcified Plaque (CP)
● Total Plaque


Digital Imaging
And
Communications In
Medicine (DICOM)
Set

Medical device
software - Software
l ife cycle processes

Medical Devices -
Application Of Risk
Management To
Medical Devices

Medical Devices -
Part 1: Application
Of Usability
Engineering To
Medical Device

Table 4: Standards applied to device development


Safety, performance, cybersecurity and usability of Cleerly Labs have been evaluated and

verified in accordance with software pre-defined specifications and applicable

performance standards through software verification and validation testing.

• Verification and validation testing confirmed that the software requirements

fulfilled the pre-defined acceptance criteria.

• A Usability test was conducted with U.S. board certified radiologists and

technicians to ensure the clinical acceptability of the device.

• The machine learning algorithms were evaluated by comparing the output of the

software to that of the ground truth using multiple ground truthers.

• A side-by-side comparison testing was conducted to evaluate the simple rule-based

calculations as they compared to an already cleared device with a similar intended

• A cybersecurity penetration testing was conducted to ensure that there were no

unidentified vulnerabilities and that the appropriate risk control measures were

implemented to protect from known vulnerabilities when the device is subject to a

The non-clinical verification and validation test results established that the device meets

its design requirements and intended use. During the development, potential hazards were

evaluated and controlled through risk management activities. The performance testing

demonstrates that the device meets all its specifications.

No clinical testing was conducted to demonstrate safety or effectiveness as the device’s

non-clinical (bench) testing was sufficient to support the intended use of the device.


Subject Device
Aidoc Briefcase for CSF triage

Predicate Device
Aidoc Briefcase for ICH triage (K180647)

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

BriefCase is a radiological computer aided
triage and notification software indicated
for use in the analysis of cervical spine CT
images. The device is intended to
assist hospital networks and trained
radiologists in workflow triage by flagging
and communication of suspected positive
findings of linear lucencies in the cervical
spine bone in patterns compatible with
fractures.
BriefCase uses an artificial intelligence
algorithm to analyze images and highlight
cases with detected findings on a
standalone desktop application in parallel
to the ongoing standard of care image
interpretation. The user is presented
with notifications for cases with suspected
findings. Notifications include compressed
preview images that are
meant for informational purposes only and
not intended for diagnostic use
beyond notification. The device does not
alter the original medical image and is not
intended to be used as a diagnostic device.
The results of BriefCase are intended to be
used in conjunction with other
patient information and based on their
professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of
care.

DICOM Information about the patient,
study and current image

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

Artificial intelligence algorithm with
database of images


Presentation of a small, compressed, black
and white preview image that is labeled
“Not for diagnostic use”;
The device operates in parallel with the
standard of care, which remains the default
option for all cases.


Picture archiving and communications system

Product Code Name
System, Image Processing, Radiological

4. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]


Proposed Device
Predicate Device
Reference Device

Manufacturer
MEDICALIP.CO.,LTD
Materialise N.V.
3D Systems, Inc.

MEDIP PRO is intended for
use as a software interface
and image segmentation
system for the transfer of
DICOM imaging
information from a medical
scanner to an output file. It
is also used as pre-operative
software for treatment
planning.
The 3D printed models
generated from the output
file are meant for non-
diagnostic use. MEDIP PRO
should be used in
conjunction with other
diagnostic tools and expert
clinical judgement.

Mimics inPrint is intended
for use as a software
interface and image
segmentation system for the
transfer of DICOM imaging
information from a medical
scanner to an output file. It
is also used as pre-operative
software for treatment
planning. For this purpose,
the Mimics inPrint output
file can be used for the
fabrication of physical
replicas of the output file
using traditional or additive
manufacturing methods.
The physical replica can be
used for diagnostic purposes
in the field of orthopedic,
maxillofacial and
cardiovascular applications.
Mimics inPrint should be
used in conjunction with
other diagnostic tools and
expert clinical judgement.

The D2P software is
intended for use as a
software interface and
image segmentation system
for the transfer of imaging
information from a medical
scanner such as a CT
scanner to an output file. It
is also intended as pre-
operative software for
surgical planning.
3D printed models
generated from the output
file are meant for visual,
non-diagnostic use.

Type of Use
Prescription Use
Prescription Use
Prescription Use

Component
Stand-alone software
Stand-alone software
Stand-alone software

Analysis & Measurement
Image Enhancement
2D/3D visualization
Segmentation
3D Rendering
Exporting STL data for 3D
Printing

Table 1. Technological Characteristics Comparison


Min. 64-bit Microsoft Windows 10
Rec. 64-bit Microsoft® Windows® 10

Min. Intel® Pentium® 4 or AMD Athlon™ 64, 3 GHz or faster or Intel® or
AMD dual core 2 GHz or faster
Rec. Intel® Core i74790 K or equivalent

Min. 100 GB free disk space for local study database
Rec. 250 GB free disk space or more for local study database

Min. Microsoft® DirectX 10® capable graphics card or higher

The following table lists the principal characteristics and features of the software:


Rec. Microsoft® DirectX 11® or capable graphics card or higher (for
example GeForce GT 730)

1,280 x 1,024 or higher screen resolution

-DICOM: Digital Imaging and Communications in Medicine (DICOM) is a
standard for handling, storing, printing, and transmitting information in
medical imaging.
-LIEBRE Study: A LIEBRE study is a set of files storing each processed
case.
- Navigation System File Format: Format for Navigation system.
Snapshots: Snapshots in PNG format.
-Videos: Videos in MPEG format and MPEG-1 video codec.

-Application workflow navigation tool.
-Toolbar.
-Working area.
-Toolbox.

-Importing Cardiac Imaging (MRI/CTA) in DICOM format
MRI Images support:
• Visualization of the distribution of the enhancement in a three-
dimensional (3D) chamber of the heart
• Quantification of the total volume of the enhancement within the
Left Ventricle (LV) and the visualization of the enhancement area
in multiple layers through the cardiac structure
• Calculation, quantification and visualization of corridors of
intermediate signal intensity enhancement in the LV
• Quantification and visualization of the total area and distribution of
the enhancement within the Left Atrium (LA)
CTA images support:
• Quantification of LV wall thickness
• Identification and Visualization of other 3D anatomical structures
- The ADAS 3D exports data into industry standard file formats supported
by catheter navigation systems

All analysis results can be saved and reloaded again for reviewing and/or
exporting. The analysis results include the input DICOM image, 3D
models, numerical values, snapshots and videos.

-Left Ventricle Layer Computation
-Left Atrium Layer Computation Algorithm
-Enhancement Quantification algorithm
-3D Corridor Detection Algorithm
-Heart Anatomy Extraction algorithm
-From Binary image to surface mesh algorithm
-Left Ventricle Wall Thickness algorithm


Proposed Device
ADAS 3D
(GALGO MEDICAL S.L)

ADAS 3D is indicated for use in the
clinical setting to support the
visualization and analysis of cardiac
MR and CTA images for patients with
cardiovascular disease.
ADAS 3D is indicated for patients with
myocardial scar produced by ischemic
or non-ischemic heart disease. ADAS
3D processes MR and CTA images.
The quality and the resolution of the
original images determines the
quality and the accuracy of the data
produced by ADAS 3D.
ADAS 3D is indicated to be used by
qualified medical professionals
(cardiologists, electrophysiologists,
radiologists or trained technicians)
for the calculation, quantification and
visualization of cardiac images. The
data produced by ADAS 3D is
indicated to be used to support
clinical decision making and should
not be used on an irrefutable basis or
as the sole source of information for

MR-CT VVA is indicated for use in
clinical settings where more
reproducible than manually derived
quantified results are needed to
support the visualization and
analysis of MR and CT images of the
heart and blood vessels for use on
individual patients with
cardiovascular disease. Further, MR-
CT VVA allows the quantification of
cerebral spinal fluid in MR velocity-
encoded flow images.
When the quantified results
provided by MR-CT VVA are used in
a clinical setting on MR and CT
images of an individual patient, they
can be used to support the clinical
decision making for the diagnosis of
the patient. In this case, the results
are explicitly not to be regarded as
the sole, irrefutable basis for clinical
diagnosis, and they are only
intended for use by the responsible
clinicians.

Comparison of the proposed devices with the predicate device is summarized in the following table


clinical diagnosis or patient
treatment.
ADAS 3D is not intended to identify
regions for catheter ablation or
treatment of arrhythmias.


 Identification and
visualization of other 3D
anatomical structures.
ADAS-3D exports information to
multiple industry standard file
formats suitable for documentation
and information sharing purposes.
The 3D data is exported into industry
standard file formats supported by
catheter navigation systems. It is
intended to be used by qualified
medical professionals (cardiologists,
electrophysiologists, radiologists or
trained technicians) experienced in
examining and evaluating
cardiovascular MR and CTA images as
part of the comprehensive diagnostic
decision-making process. ADAS-3D is
a standalone software application.

Is a software solution for the
visualization and analysis of
cardiovascular MR and CT images.

Is software intended to be used for
the visualization and analysis of MR
and CT images of the heart and
blood vessels.

Individual patients with
cardiovascular disease.

Anatomical
Left Ventricle and Left Atrium
Left ventricle and Right Ventricle
Similar than


It is intended to be used by qualified
medical professionals (cardiologists,
radiologists or trained technicians)
experienced in examining and
evaluating cardiovascular MR and
CTA images as part of the
comprehensive diagnostic decision-
making process.

Must be used by Cardiologist,
radiologist or trained technicians
who are qualified to perform cardiac
analysis.

Vendor independent DICOM MR/CT
images (specific requirements
depends on type of analysis, but
imaging viewing is possible on all
MR/CT images)

Vendor independent DICOM MR/CT
images (specific requirements
depend on type of analysis, but
imaging viewing is possible on all
MR/CT images)

By visualization and analysis of the
images

- 2D slice review
- 3D Multiplanar reconstruction
- Pan/zoom; magnify; maximize and
minimize; scroll through slice stack;
adjust window level, contrast and
brightness.
- Cine loop
- Performing caliper measurements

- Numerical
- Graph
- Bulls Eye View
- 2D view
- 3D view

- Snapshots as PNG
- Videos as MPEG
- Numerical data as TXT
- Study data as an internal file format

- Images, movie frames, movies,
graphs, snapshots and reports in
various file formats or as DICOM
secondary captures
- Reports can be exported in TXT,
PDF, HTML, XML and as DICOM SC
directly to PACS


Proposed Device
ADAS 3D
(GALGO MEDICAL S.L)

- All analysis results can be saved
and reloaded again for reviewing
and/or exporting

Cardiac Function Quantification:
mass, wall motion, wall thickness
and wall thickening

- Identification and Visualization of
other 3D anatomical structures

- Visualization of the distribution of
the enhancement in a three-
dimensional (3D) chamber of the
heart.
- Quantification of the total volume
of the enhancement within the Left
Ventricle (LV) and the visualization
of the enhancement area in
multiple layers through the cardiac
structure.
- Calculation, quantification and
visualization of corridors of
intermediate, signal intensity
enhancement in the LV.

Signal intensity analysis for the
myocardium and infarct sizing. Also
referred as DSI (Delayed Signal
Intensity)

Similar to
predicate
device (see
detailed
comparison
in the
section
below)

MR parametric maps (such as T1,
T2, T2* relaxation)

N/A
(additional
specificatio
ns for the
predicate
device, not
included on
the
proposed
device)


intermediate, signal intensity
enhancement in the LV.


EchoMD Automated
Ejection Fraction
Software


In accordance with 21 CFR 80
7.87(h) and (21 CFR 807.92) the 51

Submission Correspondent:
Donna-Bea Tillman, Ph.D.

Device Common Name:
P
icture Archiving and Communicati

Classification Name
2
1 CFR 892.2050 System, Image Pr


Phase 3 validation of the
automated Bone Scan Index
association with overall
survival in men with metastatic
castration-resistant prostate
cancer

Association of aBSI with
clinical outcome –
overall survival,
progression free survival,
opioid induced survival

Prospective Planned
Analysis – A multi-site
study phase III: NTC
01234311

Optimizing Radiographic
Progression Free Survival by
Prostate Cancer Working
Group (PCWG) Criteria using
the Automated Bone Scan
Index (aBSI)

Comparison of aBSI
increase against counting
number of new lesions
(by PCWG criteria) in
radiographic progression

Retrospective study at
Memorial Sloan Kettering
Cancer Center – single site


MultiModal Imaging Services Corporation (dba HealthLytix)

4747 Executive Drive, Suite 820
San Diego, CA 92121

Picture Archiving and Communications System

System, Image Processing, Radiological) (21 CFR 892.2050)

Eigen ProFuse CAD (K173744)
As of submission date this predicate device has not been subject to
a design-related recall.
No reference devices were used in this submission.


DICOM Input
DICOM compatible
DICOM compatible

Post-processing analysis of
Diffusion MRI data with
multi-compartment RSI
model.

Post-processing analysis of
Diffusion MRI data with single
compartment DWI model.

Automated Prostate
Segmentation: RSI-MRI+
software provides automatic
prostate segmentation,
quantification, and reporting
of derived image metrics.

Manual Prostate
Segmentation: ProFuse CAD
has a marking feature that
allows the user to manually
segment the prostate and
provides quantification and
reporting of derived image
metrics.

Automated fusion of derived
Diffusion MRI data with
anatomical MRI data in
addition to other data sources

DICOM output
DICOM compatible
DICOM compatible

Display/measurement data
can be viewed, accepted, or
rejected by a physician.

Hospital, Clinic, Medical Office,
Home Office


RSL-D-RC-2D Traditional 510(k) Submission RayCare 2.3


750 N San Vicente Blvd Ste. 800 West, West Hollywood, CA
90069, USA

Anjali Nair
Regulatory Affairs Specialist at Fluidda Inc.
Tel: +91 9324857705
Email: anjali.nair@fluidda.com

Common Name
Quantitative CT analysis system

Classification Name
Computed Tomography X-Ray System

Legally marketed Primary Predicate Device

Vida Pulmonary Workstation 2 (PW2), Vida Diagnostics
(K083227)

Predicate Regulation Number
21 CFR 892.1750

Class II; Product Code- JAK
The predicate device has not been subject to a design-related
recall.


Scanner manufacture
GE Healthcare; Philips; Siemens

LightSpeed VCT; LightSpeed Pro 16; LightSpeed 16; Revolution CT;
Revolution EVO; iCT 256; Emotion 16; SOMATOM Definition AS; SOMATOM
Force; SOMATOM Definition Flash; Brilliance 64; Definition; Definition AS+;
Discovery CT750 HD; Sensation 64

datasets used for the performance testing are:


Manufacturer Name
Zebra Medical Vision Ltd.

The red dot™ device is substantially equivalent to the following device:


New Device
Predicate Device
Predicate Device

for the dimensions of vessels
and structures.
Calcium quantification and
scoring.
Various visualization
techniques: 2D/3D/4D
visualization, MPR, Curved
MPR, Stretched MPR, MIP,
MinIP, Raysum and MAR.
Capture and Report.

Support is provided for digital
image processing to derive
metadata or new images from input
image sets, for internal use or for
forwarding to other devices using
the DICOM protocol. Image
processing tools are provided to
extract metadata to derive
parametric images from
combinations of multiple input
images, such as temporal phases, or
images co-located in space but
acquired with different imaging
parameters, such as different MR
pulse sequences, or different CT
image parameters (e.g. dual
energy).
iNtuition is designed for use by
healthcare professionals and is
intended to assist the physician in
diagnosis, who is responsible for
making all final patient
management decisions.
Interpretation of mammographic
images or digitized film screen
images is supported only when the
software is used without
compression and with an FDA-
Approved monitor that offers at
least 5Mpixel resolution and meets
other technical specifications
reviewed and accepted by the FDA.
iNtuitionMOBILE provides
wireless and portable access to
medical images. This device is not
intended to replace full
workstations and should be used
only when there is no access to a
workstation. Not intended for
diagnostic use when used via a web
browser or mobile device.

Measurement and annotation
tools
Reporting tools

TeraRecon, Inc. iNtuition-Structural Heart Module 510(K)


- CT, MR, Nuc, PET,
Angio, US/Echo,
SPECT,
- CR/DR Review
- 2D, 3D, 4D Medical
Image review including
cine play

- CT, MR, Nuc, PET, Angio,
US/Echo, SPECT, CR/DR
Review
- 2D, 3D, 4D Medical Image
review including cine play

- CT data in DICOM
format (vendor
independent)

- Manual through
keyboard/mouse
- Command line interface


- Importing
- Exporting
- Deleting
- Search
- Anonymization

- Exporting
- Deleting
- Anonymizing (no
automatic deletion of
original patient data)
- Search

- Automatic and manual
centerlines
- Centerline edits and
refinements.
- Vessel Analysis
- Automatic and manual
segmentation of
structures
- Segmentation editing

- Realign orthogonal
MPR's
- Segmentation toolset:
- Automatic segmentation
- Automatic centerline
- Manual centerline
- Centerline editing
- Undo/Redo operations
- Volume sculpting

- Linear (length, diameter,
perimeter), distance pair,
angular and ROI
measurements
- Area measurements
- Volume measurements
including volumetric
histogram, VOI and TVA
for Time Volume
Analysis for heart
chamber segmentation
and analysis
- C-arm angulation
calculation
- Text and arrow
annotations
- Anatomy ID (Landmark
Label Selection)
- Calcium scoring for
assessment of calcium in
the aortic root
- Calcium scoring for
assessment of calcium in
the coronary arteries
- Segmentation and
analysis of coronary
artery tree centerline
- Synchronized side-by-
side review
- Synchronized center of
rotation viewing
- Findings workflow for
temporal correlative
analysis
- 2D/3D Batch movie tool
and export

- Linear (length and
diameter), angular and
ROI measurements
- Volume measurements
- C-arm angulation
calculation
- Text and arrow
annotations
- Calcium scoring for
assessment of calcium in
the aortic root
- Calcium scoring for
assessment of calcium in
the coronary arteries
- Segmentation and
analysis of coronary
artery tree centerline


- Volume rendering, MIP,
MPR, MinIP, Raysum
(ThickMPR)
- 3D triangulation
- Perspective endoluminal
view
- Medial Axial Reformat
(MAR)
- Curved Planar Reformat
(CPR)
- Double-oblique MIP and
MPR
- Image enhancement
filters
- Synchronized side-by-
side viewing
- Synchronized center of
rotation viewing
- Cube View
- Workflow templates
- Multi-Mask Display
(multi- object display)
- User-defined
measurement protocols
- Editing tools: crop, cut,
free- hand

- Volume rendering,
- MIP, MPR, MinIP,
- Raysum (ThickMPR)
- 3D triangulation
- Perspective endoluminal view
- Medial Axial Reformat (MAR)
- Curved Planar Reformat
(CPR)
- Double-oblique MIP and MPR
- Image enhancement filters
- Synchronized side-by- side
viewing
- Synchronized center of
rotation viewing
- Cube View
- Workflow templates
- Multi-Mask Display (multi-
object display)
- User-defined measurement
protocols
- Editing tools: crop, cut, free-
hand

- Orthogonal, oblique,
double oblique, curved,
cross-curved, stretched
- MPR rendering
- MIP, AveIP, MinIP and
color volume slabs
- MIP volume rendering
- Color volume rendering
- Grayscale volume
rendering
- 2D slice review and stack
comparison
- 4D cine
- Interactive VOI clipping
- Multi-tissue color and
opacity control
- Active presets
- User-defined presets

- Structured reporting with
xml, text, xls output
- Word and html report
- DICOM SC
- Workflow scenes: restore
saved state

-
- Printout
- Session state
- PDF format
- DICOM PDF report

Operating System
Microsoft Windows
Microsoft Windows
Microsoft Windows


Currently Marketed
Predicate QLAB
(Predicate Device -
K181264)

Proposed QLAB 3D
Auto RV
(Modified Device)

QLAB Quantification
software is a software
application package.
It is designed to view
and quantify image
data acquired on
Philips ultrasound
systems.

Indications for use of
TomTec-Arena TTA2
software are quantification
and reporting of
cardiovascular, fetal,
abdominal structures and
function of patients with
suspected disease to
support the physicians in
the diagnosis


Currently Marketed
Predicate QLAB
HeartModel (K181264)

Proposed QLAB 3D
Auto RV (Modified
Device)

The HeartModel provides
semi-automatic 3D
anatomical border
detection and
identification of the heart
chambers for the end-
diastole (ED) and end-
systole (ES) cardiac
phases.

The TOMTEC
ARENA 4D RV-
Function provides a
morphological and
functional assessment
of the right ventricle
based on a surface
model of the RV.

The 3D Auto RV Q-App
is an integration of the
segmentation engine of
the QLAB HeartModel
and the TomTec-Arena
4D RV-Function thereby
providing a dynamic
Right Ventricle clinical
functionality.

Integrates HeartModel
auto-segmentation
technology with
TomTec Arena’s 4D-
RV algorithm for RV
border placement.

Semi-automatic border
detection and
identification of LV and
LA chambers

Functional assessment
of RV based on a RV
surface model.

Integrates HeartModel
auto-segmentation
technology with TomTec
Arena’s 4D-RV
algorithm for RV border
placement

Anatomical
enhancement by Right
Ventricle

 RVDd base (RVD1):
Right Ventricle
Distance base (mm)
 RVDd mid (RVD2):
Right Ventricle
Distance medial
(mm)
 RVLd (RVD3): Right
Ventricle Distance
Longitudinal (mm)
 TAPSE: Tricuspid
annular plane systolic
excursion (mm)
 FAC: Fractional area
change (%)
 RVLS (free wall):
right ventricular
longitudinal strain
(free wall) (%)
 RVLS
(Septum): right
ventricular
longitudinal strain
(septum) (%)

 Global strain
 TAPSE: MMode
measurement for
movement of TV
between ED and ES


 RV distance
measurements: 3
distance
measurements in the
RV A4C in ED.
 RVD1: maximal
short-axis dimension
in the basal one third
of the right ventricle
 RVD2: distance is
measured on 50% of
RVLd (RVD3) and
parallel to the RVD1
 RVD3: base–apex
length
 Fractional area
change (FAC)

 RV distance
measurements: 3
distance measurements
in the RV A4C in ED.
 RVD1: maximal short-
axis dimension in the
basal one third of the
right ventricle
 RVD2: distance is
measured on 50% of
RVLd (RVD3) and
parallel to the RVD1
 RVD3: base–apex
length
 Fractional area change
(FAC)

 EDV: End-diastolic
Volume
 EDVI: End-diastolic
Volume Index
 ESV: End-systolic
Volume
 ESVI: End-systolic
Volume Index
 SV: Stroke Volume
 EF: Ejection Fraction

EDV measurement
includes semi-
automatic function
introduced in
3DAutoRV. All other
measurements identical
to 4D RV predicate.

 EF: Ejection Fraction
 SV: Stroke Volume

3D surface model is
created semi-
automatically without
user interaction.
User is required to edit,
accept or reject the
contours

3D surface model is
created based on user
defined anatomical
landmarks. User is
able to edit the contour
of the surface model.

3D surface model is
created semi-
automatically using
machine learning
algorithms without user
interaction. User is able
to edit, accept or reject
the contours or the
anatomical landmarks.

Workflow
improvements for user
convenience.
Algorithm Training
procedure is same
between the subject and
the predicate
HeartModel, except
that the algorithm is
applied to LV in
HeartModel, while to
RV in subject 3D auto
RV.


883 Santa Cruz Ave, Suite 205
Menlo Park, CA 94025

Trade name: ZOOM
Manufacturer: Zetta Medical Technologies, LLC.
1313 Ensell Road
Lake Zurich, IL 60047
Regulation Number: 21 CFR 892.2050
Regulation Name: System, Image Processing,
Radiological
Device Class: Class II
Product Code: LLZ
510(k) Number: K172768
510(k) Clearance Date: April 24, 2018


Software package that operates on
off-the-shelf hardware

The software processes DICOM
compliant image data

The software is designed for use
on a radiology workstation.

None – enhanced images are
viewed on existing PACS
workstations

Table 5-2. Summary of Technological Characteristics Comparison.


ZOOM image enhancement
software implements a noise
reduction algorithm using
wavelets and image guided
filtering. Original images are
decomposed into different
wavelet sub bands and noise in
each band is a soft threshold. De-
noised images are reconstructed
from soft thresholded images
using inverse wavelet transform.

SubtleMR software implements
an image enhancement
algorithm using convolutional
neural network based filtering.
Original images are enhanced
by running through a cascade of
filter banks, where thresholding
and scaling operations are
applied. Separate neural
network based filters are
obtained for noise reduction
and sharpness increase. The
parameters of the filters were
obtained through an image-
guided optimization process.

The software, which is installed
on a remote computer, receives
DICOM images from MRI host
computer, automatically
processes the received images and
sends the enhanced images to a
PACS server. Enhanced images
exist in conjunction to the original
images.

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


ITEM
Proposed Device
Predicate Device K182624

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.

MIM software is used by trained medical
professionals as a tool to aid in
evaluation and information management
of digital medical images. The medical
image modalities include, but are not
limited to, CT, MRI, CR, DX, MG, US,
SPECT, PET and XA as supported by
ACR/NEMA DICOM 3.0. MIM assists
in the following indications:
• Receive, transmit, store, retrieve,
display, print, and process medical
images and DICOM objects.
• Create, display and print reports from
medical images.
• Registration, fusion display, and
review of medical images for diagnosis,
treatment evaluation, and treatment
planning.
• Evaluation of cardiac left ventricular
function and perfusion, including left
ventricular enddiastolic volume,
end-systolic volume, and ejection
fraction.
• Localization and definition of objects
such as tumors and normal tissues in
medical images.
• Creation, transformation, and
modification of contours for applications
including, but not limited to, quantitative
analysis, aiding adaptive therapy,
transferring contours to radiation therapy
treatment planning systems, and

Table 1 Comparison of Technology Characteristics


archiving contours for patient follow-up
and management.
• Quantitative and statistical analysis of
PET/SPECT brain scans by comparing to
other registered PET/SPECT brain scans.
• Planning and evaluation of permanent
implant brachytherapy procedures (not
including radioactive microspheres).
• Calculating absorbed radiation dose as
a result of administering a radionuclide.
When using device clinically, the user
should only use FDA approved
radiopharmaceuticals. If using with
unapproved ones, this device should only
be used for research purposes.
Lossy compressed mammographic
images and digitized film screen images
must not be reviewed for primary image
interpretations. Images that are printed to
film must be printed using an
FDA-approved printer for the diagnosis
of digital mammography images.
Mammographic images must be viewed
on a display system that has been cleared
by the FDA for the diagnosis of digital
mammography images. The software is
not to be used for mammography CAD.

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

Operating System
Windows
Windows and MAC system

No Limitation on scanner model,
DICOM 3.0 compliance required.

No Limitation on scanner model,
DICOM3.0 compliance required.

No Limitation on TPS model, DICOM
3.0 compliance required.


Algorithm
Intensity Based
Intensity Based

CT, MRI, CR, DX, MG, US, SPECT,
PET and XA


UNMODIFIED Device
ProFound™ AI V2
(PowerLook® Tomo Detection
V2 Software)

Regulation Number
21 CFR 892.2090
21 CFR 892.2090

ProFound™ AI V2
(PowerLook® Tomo Detection
V2) is a computer-assisted
detection and diagnosis (CAD)
software device intended to be
used concurrently by interpreting
physicians while reading digital
breast tomosynthesis (DBT)
exams from compatible DBT
systems. The system detects soft
tissue densities (masses,
architectural distortions and
asymmetries) and calcifications
in the 3D DBT slices. The
detections and Certainty of
Finding and Case Scores assist
interpreting physicians in
identifying soft tissue densities
and calcifications that may be
confirmed or dismissed by the
interpreting Physician.

ProFound™ AI V2.1 is a
computer-assisted detection and
diagnosis (CAD) software device
intended to be used concurrently
by interpreting physicians while
reading digital breast
tomosynthesis (DBT) exams
from compatible DBT systems.
The system detects soft tissue
densities (masses, architectural
distortions and asymmetries) and
calcifications in the 3D DBT
slices. The detections and
Certainty of Finding and Case
Scores assist interpreting
physicians in identifying soft
tissue densities and calcifications
that may be confirmed or
dismissed by the interpreting
Physician.

Symptomatic and asymptomatic
women
undergoing mammography.


Image processing device
intended to aid in the detection,
localization, and characterization
of soft tissue densities (masses,
architectural distortions
and asymmetries) and
calcifications in the 3D DBT
slices.

Output Device
Softcopy Workstation
Softcopy Workstation

Deployment
Standalone computer
Standalone computer

Supported Digital
Breast Tomosynthesis
Systems

ProFound AI V2 Software:
• Hologic Selenia Dimensions
• Ge Senographe SenoClaire
• GE Senographe Pristina

Profound AI V2 Software:
• Hologic Selenia Dimensions
• Ge Senographe SenoClaire
• GE Senographe Pristina
ProFound AI V2.1 Software:
• Siemens Mammomat
Inspiration
• Siemens Mammomat
Revelation


Common Name
Medical Imaging Processing Software

Classification Name
System, Image Processing, Radiological

Picture archiving and communications system


Picture archiving and
communications system


THINQ™ is intended for automatic
labeling, visualization and
volumetric quantification of
segmentable brain structures from
a set of MR images. Volumetric
measurements may be compared
to reference percentile data.

NeuroQuant is intended for
automatic labeling, visualization
and volumetric quantification of
segmentable brain structures and
lesions from a set of MR images.
Volumetric measurements may be
compared to reference percentile
data.

• Automated measurement of brain
tissue volumes and structures
• Automatic segmentation and
quantification of brain structures
using a probabilistic
neuroanatomical atlas based on
the MR image intensity

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

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

Deployment:
Container installation
Cloud based or installed

Automated internal pipeline that
performs:
• Artifact correction
• Segmentation
• Volume calculation
• Report generation

Automated internal pipeline that
performs:
• Artifact correction
• Segmentation
• Lesion quantification
• Volume calculation
• Report generation

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

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


• Provides volumetric
measurements of brain structures
• Includes segmented color
overlays and morphometric reports
• Automatically compares results to
reference percentile data
• Report output is PDF file format
• Outputs segmentation results as
overlay in DICOM Encapsulated
JPEG format allowing display on
DICOM workstations and Picture
Archive and Communications
System

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

• Automated quality control
functions:
• Scan sequence (protocol) checks
• Atlas alignment checks
• Cortical surface checks
• Result validity checks
• Results must be reviewed by a
trained physician

• Automated quality control
functions:
• Tissue contrast check
• Scan protocol verification
• Atlas alignment check
• Results must be reviewed by a
trained physician


Left Cerebral White Matter Dice 0.86 ( 0.04)


Right Cerebral White Matter
1.10 ( 1.20)


Comparison of the Subject Device to the Predicate Device

Creation of new geometric treatment plans for photon radiotherapy. The syngo.via workflow
supports a more user intuitive workflow (i.e. a more modern look and feel).
Modification: Beam placement auto shape now also allows in creating rectangular block
fields.

Reference Point Management allows the user to edit the position, color, and type of Points of
Interest (POI).
Modification: The workflow for reference point creation has been simplified and a
streamlined workflow for breast iso-centering has been implemented.

Sending of reference points with offset details to a laser system.
Modification:Support of simplified workflow for breast iso-centering. Enabled by combining
improvements in iso-centering contouring the breast. It identifies the breast boundaries and
suggests a proper iso-center for breast treatment.

Routine Contouring tools (e. g. freehand drawing tools, creation of margins etc.)
Modificationsinclude capability of interpolating contours, 3D Pan/Scale options, and option
to add rectangular and ellipse as contour shapes, improvement in nudge tool to enable auto
filling of the inner part of a closed contour, and restricting the margin extension to external
contour.

Advanced Contouring tools (automatic contouring of different structures, nudge 3D tool,
contour interpolation etc.). Automatic contouring of pelvic and head/neck regions, support of
Rapid Results Technology.
Modification: This subject device provides the following extensions:
(cid:120) Automatic Contouring can be applied on further structures (thoracic and abdominal
regions)
(cid:120) A new deep learning-based approach that uses an adversarial network has been
implemented

The Structure Set Management provides the following functionality:
(cid:120) Loading and storing of DICOM RT structure sets, creating, editing and deletion of
structures and POIs.
(cid:120) Creating, editing and deletion of structure templates.
(cid:120) Customize predefined structure database with mapping to international nomenclature
schemes.
Modificationincludes simplifying the user interface.

provided as Table 4below for the software version SOMARIS/8 VB40:


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

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

Medical devices –Application of risk
management to medical devices; 14971
Second Edition 2007-03-01

Medical devices -Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015

Siemens claims conformance to the following performance standards:


INTENDED USE:
DIAGNOSTIC ULTRASOUND IMAGI
NG OR
FLUID FL
OW ANAL
YSIS OF
THE HUMA
N BODY AS
FOLLOWS:

Clinical Applicatio
n
Mode o
f Operatio
n

General
Specific
B M
Color
Power
PW
Combined
(Specify)
Other*

(Track 1 Only)
(Tracks 1 & 3)
Doppler
Doppler
Doppler

Fetal Imaging &
Fetal
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Other
Abdominal
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Intra-operative
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Pediatric
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Small Organ
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Adult Cephalic
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Trans-rectal
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD

Trans-vaginal
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD

Musculo-skeletal (Conventional)
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Musculo-skeletal (Superficial)
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Other (Urology, Gynecology)
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD

Cardiac
Cardiac Adult
P P
P
N
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Cardiac Pediatric
P P
P
N
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Peripheral Vessel
Peripheral Vessel
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Other (Carotid)
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

N = new indication;
P = previously cleared by K180799

FORM FDA 38
81 (8/14) Cont'd
Page
2 of 12


Abdominal
N
N
N
N
N
B+M; B+CD; B+PD; B+PWD

Intra-operative
(Abdominal organs & vascular)

Pediatric
N
N
N
N
N
B+M; B+CD; B+PD; B+PWD

Small Organ
(Thyroid, Prostate, Scrotum, Breast)

Adult Cephalic
N
N
N
N
N
B+M; B+CD; B+PD; B+PWD

Musculo-skeletal (Conventional)
N
N
N
N
N
B+M; B+CD; B+PD; B+PWD

Other (Urology, Gynecology)
N
N
N
N
N
B+M; B+CD; B+PD; B+PWD

Cardiac
Cardiac Adult
N
N
N
N
B+M; B+CD; B+PWD

Cardiac Pediatric
N
N
N
N
B+M; B+CD; B+PWD

Peripheral Vessel
Peripheral Vessel
N
N
N
N
N
B+M; B+CD; B+PD; B+PWD

N = new indication; P = previously cleared by K180799
Note 1: Needle Enhancement in B-Mode.

INTENDED USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS:


Cardiac
Cardiac Adult
N
N
N
N
N
B+M; B+CD; B+PD; B+PWD


Trans-rectal
N
N
N
N
N
B+M; B+CD; B+PD; B+PWD

Trans-vaginal
N
N
N
N
N
B+M; B+CD; B+PD; B+PWD


INTENDED USE:
DIAGNOSTIC ULTRASOUND IMAGI
NG OR
FLUI
D FLOW ANAL
YSIS OF
THE HUMA
N BODY AS
FOLLOWS:

Clinical Applicatio
n
Mode
of Ope
ration

General
Specific
B M
Color
Power
PW
Combined
(Specify)
Other*

(Track 1 Only)
(Tracks 1 & 3)
Dopp
ler Doppler
Doppler

Other
Abdominal
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

Intra-operative
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

Pediatric
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

Small Organ
N
N
N
N
B+CD; B+P
D; B+PWD
Note 1

Musculo-skeletal (Conventional)
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

Musculo-skeletal (Superficial)
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

Peripheral Vessel
Peripheral Vessel
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

Other (Carotid)
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

N = new indication;
P = previously cleared by K180799

FORM FDA 38
81 (8/14) Cont'd
P
age 6 of 12


INTENDED USE:
DIAGNOSTIC ULTRASOUND IMAGI
NG OR
FLUID FL
OW ANAL
YSIS OF
THE HUMA
N BODY AS
FOLLOWS:

Clinical Applicatio
n
Mode o
f Operatio
n

(Track 1 Only)
(Tracks 1 & 3)
Doppler
Doppler
Doppler


INTENDED USE:
DIAGNOSTIC ULTRASOUND IMAGI
NG OR
FLUI
D FLOW ANAL
YSIS OF
THE HUMA
N BODY AS
FOLLOWS:

Clinical Applicatio
n
Mode
of Op
eration

General
Specific
B M
Color
Power
PW
Combined
(Specify)
Other*

(Track 1 Only)
(Tracks 1 & 3)
Dopp
ler Doppler
Doppler

Fetal Imaging &
Fetal
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

Other
Abdominal
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

Intra-operative
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

Adult Cephalic
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

Cardiac
Cardiac Adult
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

Cardiac Pediatric
N N
N
N
N
B+M; B+CD
; B+PD; B+P
WD Note 1

FORM FDA 38
81 (8/14) Cont'd
P
age 8 of 12


Abdominal
P
P
P
P
P
B+M; B+CD; B+PD; B+PWD

Intra-operative
(Abdominal organs & vascular)

Pediatric
P
P
P
P
P
B+M; B+CD; B+PD; B+PWD

Small Organ
(Thyroid, Prostate, Scrotum, Breast)

Adult Cephalic
P
P
P
P
P
B+M; B+CD; B+PD; B+PWD

Musculo-skeletal (Conventional)
P
P
P
P
P
B+M; B+CD; B+PD; B+PWD

Other (Urology, Gynecology)
P
P
P
P
P
B+M; B+CD; B+PD; B+PWD

Cardiac
Cardiac Adult
P
P
P
P
B+M; B+CD; B+PWD

Cardiac Pediatric
P
P
P
P
B+M; B+CD; B+PWD

Peripheral Vessel
Peripheral Vessel
P
P
P
P
P
B+M; B+CD; B+PD; B+PWD

N = new indication; P = previously cleared by K180799
Note 1: Needle Enhancement in B-Mode.


Cardiac
Cardiac Adult
P
P
P
P
P
B+M; B+CD; B+PD; B+PWD


Trans-rectal
P
P
P
P
P
B+M; B+CD; B+PD; B+PWD

Trans-vaginal
P
P
P
P
P
B+M; B+CD; B+PD; B+PWD


INTENDED USE:
DIAGNOSTIC ULTRASO
UND IMAGI
NG OR
FLUID FL
OW ANAL
YSIS OF
THE HUMA
N BODY AS
FOLLOWS:

Clinical Applicatio
n
Mode o
f Operatio
n

General
Specific
B M
Color
Power
PW
Combined
(Specify)
Other*

(Track 1 Only)
(Tracks 1 & 3)
Doppler
Doppler
Doppler

Other
Abdominal
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Intra-operative
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Pediatric
P P
P
P
P
B+M; B+CD
; B+PD
Note 1

Small Organ
P
P
P
P
B+CD; B+P
D; B+PWD
Note 1

Musculo-skeletal (Convent
ional)
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Musculo-skeletal (Superfic
ial)
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Peripheral Vessel
Peripheral Vessel
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

Other (Carotid)
P P
P
P
P
B+M; B+CD
; B+PD; B+P
WD Note 1

N = new indication;
P = previously cleared by
K180799


Kolonel Begaultlaan 1b / 12
3012 Leuven
BELGIUM


Common Name:
Medical Image Processing Software

Classification Name:
System, Image processing, Radiological


Manufacturer
CuraCloud Corporation
MaxQ AI

Clinical Condition
Acute Intracranial hemorrhage
Acute Intracranial hemorrhage

Independent of
standard of care
workflow

Output
Suspected ICH (Yes or No)
Suspected ICH (Yes or No)

Results Receiver
PACS/Workstation
PACS/Workstation

Both devices also flag the suspected ICH on the DICOM images for the radiologist to review.


Company
OrthoGrid Systems, Inc.
OrthoGrid Systems, Inc.

Product Name
PhantomMSK Trauma
PhantomMSK

The subject device is an
image processing software. A
fluoroscopic image is acquired
from a C-arm by the software
and displayed outside the
sterile field, where the image
analysis tools can be used at
the surgeon’s discretion.

The predicate device is an image
processing software. A
fluoroscopic image is acquired
from a C-arm by the software and
displayed outside the sterile field,
where the image analysis tools
can be used at the surgeon’s
discretion.

Templating, distortion
correction, measurements,
PACS and Network
compatibility.

Templating, distortion correction,
measurements.

safety or effectiveness when used as labeled.


Radiological Computer Assisted Detection and
Diagnosis Software

Classification regulation
21 CFR 892.2090


Device trade name
Transpara™ 1.3.0 (K181704)

Legal Manufacturer
ScreenPoint Medical B.V.


is a software-only device for aiding radiologists with the detection and

diagnosis of breast cancer in mammograms. The product consists of a processing server


of Transpara™ can be transmitted to external destinations, such as medical imaging

workstations or archives, using the DICOM mammography CAD SR protocol. This allows

PACS workstations to implement the interface of Transpara™ in mammography reading

calcifications and soft tissue lesions, which are trained with large databases of biopsy


automatically processes mammograms and the output of the device can be

used by radiologists concurrently with the reading of mammograms. The user interface of


Standard ID
Standard Title
FDA Recognition #

Medical Devices - Application Of Risk
Management To Medical Devices

Medical Device Software - Software Life
Cycle Processes

Decision summary with special controls
for class II radiology device

voluntary FDA recognized standards and guidelines:


SIS Software version 3.6.0
SIS Software version 3.3.0

Allows for importing of
digital imaging sets

Uses proprietary
software algorithm to
generate 3D segmented
anatomical models from
patient’s MR scans

Allows for review and
analysis of data in 2D
and 3D formats

Performs image fusion of
datasets using
automated or manual
image matching
technique

Segments structures in
images with manual and
automated tools and
converts them into 3D
objects for display

Creates hybrid datasets
by filing in segmented
regions slice-by-slice on
anatomical datasets

SIS Software Technological Characteristics Comparison Table


Segmentation of CT scan
to identify structures in
relation to those
visualized on MR

Feature to Account for
CT images with gantry tilt

Cross-registers images
and creates 3D (fused)
model

Different registration
methods (linear and non-
linear) by multiple
registration tools (ANTS
and ELASTIX)


Radiological Computer-Assisted Prioritization Software

The HealthCXR device is substantially equivalent to the following device:


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

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

Notification-only,
parallel workflow
tool

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


Identify patients with
prespecified
clinical condition

Different but as per the
product classification
definition, both identify
“time sensitive imaging.”

Yes; notification flagged for
review on hospital worklist or
Zebra list

Yes; notification flagged for
review on hospital worklist.

Similar, HealthCXR can
be directly integrated for
notification on the
hospital worklist or on
the Zebra list application.
Both notifications
operate in parallel with
the standard of care.

Independent of
standard of care
workflow

Aids prompt
identification of
cases with indicated
findings

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

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

Similar, HealthCXR
provides an additional
thumbnail view of the
original exam as preview
only on the Zebra list or
Radiology Assistant, not
for diagnostic use.

Different, but both
operating points are
substantially equivalent
to the performance
predicate device and
comply with DEN
170073 Special control
1(iii).


Treatment Plan and Image Management Application

Ethos Treatment Planning
Treatment Planning System

Ethos Radiotherapy System
Medical Linear Accelerator


ARIA Radiation Therapy Management (K173838)

Eclipse Treatment Planning System (K181145)

Ethos Radiotherapy System
Halcyon (K181032)


Ethos Treatment Management is software designed
for radiation therapy medical professionals to
support them in managing radiation treatments for
patients.

Ethos Treatment Planning is software that is
designed generate treatment plans, modify
treatment plans, and guide users within adaptive
treatment sessions.

Halcyon and Ethos Radiotherapy System are single
energy linacs designed to deliver Image Guided
Radiation Therapy and radiosurgery, using Intensity
Modulated and Volumetric Modulated Arc Therapy
techniques. They consist of an accelerator and
patient support within a radiation shielded
treatment room and a control console outside the
treatment room.


Ethos Treatment Management is used to manage
and monitor radiation therapy treatment plans and
sessions; it is intended to be used with a treatment
planning system.

Ethos Treatment Planning is used to generate and
modify radiation therapy treatment plans.

Ethos Radiotherapy System
(The intended use statement is
identical to the predicate)

Halcyon and Ethos Radiotherapy System are
intended to provide stereotactic radiosurgery and
precision radiotherapy for lesions, tumors, and
conditions anywhere in the body where radiation
treatment is indicated.

Halcyon
(The intended use statement is
identical to the predicate)


Ethos Treatment Management is indicated for use in
managing and monitoring radiation therapy
treatment plans and sessions.

Ethos Treatment Planning is indicated for use in
generating and modifying radiation therapy
treatment plans.

Halcyon and Ethos Radiotherapy System are
indicated for the delivery of stereotactic radiosurgery
and precision radiotherapy for lesions, tumors and
conditions anywhere in the body where radiation is
indicated for adults and pediatric patients.


IEC 62304
Ethos Treatment Management
Ethos Treatment Planning
Ethos Radiotherapy System and Halcyon

IEC 61217
Ethos Treatment Planning
Ethos Radiotherapy System and Halcyon

IEC 62274
Ethos Treatment Management
Ethos Radiotherapy System and Halcyon

IEC 62083
Ethos Treatment Management
Ethos Treatment Planning

IEC 82304-1
Ethos Treatment Management
Ethos Treatment Planning

IEC 62366-1
Ethos Treatment Management
Ethos Treatment Planning

IEC 60825-1
Not applicable to the software devices
Ethos Radiotherapy System and Halcyon

IEC 60976
Ethos Radiotherapy System and Halcyon

IEC 60601-1
Ethos Radiotherapy System and Halcyon

IEC 60601-1-2
Ethos Radiotherapy System and Halcyon

IEC 60601-1-3
Ethos Radiotherapy System and Halcyon

IEC 60601-1-6
Ethos Radiotherapy System and Halcyon

IEC 60601-2-1
Ethos Radiotherapy System and Halcyon

IEC 60601-2-68
Ethos Radiotherapy System and Halcyon

The devices conform in whole or in part to the following recognised standards.


Subject Device
Aidoc Briefcase for LVO triage

Primary Predicate Device
Aidoc Briefcase for ICH triage
(K180647)

Secondary Predicate Device
Viz.AI ContaCT Software
(DEN170073)

BriefCase is a radiological computer
aided triage and notification software
indicated for use in the analysis of
head CTA images. The device is
intended to assist hospital networks
and trained radiologists in workflow
triage by flagging and
communication of suspected positive
findings of Large Vessel Occlusion
(LVO) pathologies.
BriefCase uses an artificial
intelligence algorithm to analyze
images and highlight cases with
detected findings on a standalone
desktop application in parallel to the
ongoing standard of care image
interpretation. The user is presented
with notifications for cases with
suspected findings. Notifications
include compressed preview images
that are meant for informational
purposes only and not intended for
diagnostic use beyond notification.
The device does not alter the original
medical image and is not intended to
be used as a diagnostic device.
The results of BriefCase are
intended to be used in conjunction
with other patient information and
based on their professional
judgment, to assist with

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

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


professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of
care.

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.

Clinician (e.g., neurovascular
specialist)

Inclusion criteria
 Head CTA protocol with a 64-
slice scanner or higher;
 Scans performed on
adults/transitional adults ≥ 18
years of age;
 Slice thickness 0.5 mm – 1.0 mm.
Exclusion Criteria
 All scans that are technically
inadequate, including motion
artifacts, severe metal artifacts,
sub-optimal bolus timing or an
inadequate field of view.

Inclusion Criteria
 Head non-enhanced CT (NECT)
with a 64-slice scanner or higher;
 Scans performed on
adults/transitional adults ≥ 18
years of age;
 Slice thickness 0.625 mm to 5.1
mm.
Exclusion Criteria
 All scans that are technically
inadequate; including motion
artifacts, severe metal artifacts,
inadequate field of view, etc.

Inclusion Criteria:
 The patient is older than 22 years
of age when presenting to the
healthcare facility;
 The images were from patients
who underwent a stroke protocol
assessment;
and
 Head and neck CTA.
Exclusion Criteria:
Series used to identify potential LVOs
were axial thin slice CTAs. CTA series
may have been excluded because of
insufficient technical quality. Exclusion
criteria included:
 Series containing metal artifacts in
the soft matter of the brain;
 Series that are non-axial;
 Series containing missing slices;
 Series displaying no visible


contrast due to bad bolus timing
during the series acquisition
process;
 Series containing inconsistent pixel
spacing;
 Series containing slices thicker
than 0.625mm;
 Series containing improperly
ordered slices (e.g. as a result of
manual correction by an Imaging
technician); and
Series containing an incomplete skull.

DICOM Information about the
patient, study and current image

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

Artificial intelligence algorithm with
database of images.

Presentation of a small, compressed,
black and white preview image that
is labeled “Not for diagnostic use”;
The device operates in parallel with
the standard of care, which remains
the default option for all cases.

Presentation of a small, compressed,
black and white preview image that is
labeled “Not for diagnostic use”.

Structure
- AHS module (image acquisition);
- AHS module (image acquisition);
- Image Forwarding Software


(PPV) and negative predictive value (NPV) with varying prevalence:


Table 2. Time-to- notification comparison for BriefCase devices


51 Federal St., Suite 305
San Francisco, CA 94107

Sharon Cholowsky
Director of Regulatory & Compliance

Email: regulatory@arterys.com
Phone: 1 (650) 319-7230


Common Name
Medical image processing software

Classification Name
System, Image Processing, Radiological


Arterys® MICA, K182034

Product Code LLZ

Arterys® MICA, K182034

Product Code LLZ

Medis MR-CT VVA, K140587

Product Code LLZ


Common Name
of Device/
Classification
Product code

Picture Archiving and
Communications System
(PACS)
21 CFR 892.2050
LLZ- Radiological Image
Processing System

Not a clinically significant
difference – support for
latest Windows OS.

Not a clinically significant
difference – support for new
browser only

Not a clinically significant
difference – support for
latest server OS

Merge PACS™ is a Picture
Archiving and
Communication System
(PACS) for multi-modality
(CT, MR, PT, US, MG, BTO,
CR, DR/DX, NM, XA, RF,

The Xelis Fusion is a
software device that
receives digital
images and data
from various
sources (e.g. CT

There is only a minor change
in the indications for use
statement from the
previous Merge PACS
device, with the removal of
the optional Reach


interpretation should be
used for the
interpretation of
mammography studies.

Significant change(s) introduced in subject device Merge PACS:

Probe Tool, ROI Tool
Regional Area Analysis
and Regional Volume
Analysis
2D and 3D SUV
calculations

Probe Tool and ROI Tool
2D SUV calculations only

Supports 3D region
of interest (ROI) SUV
analysis

Addition of Region Area and
Volume Analysis tools allows
for additional clinical
analysis of PET images for
patient treatment, including
3D SUV calculations. The
reference predicate device
shares this new feature with
the subject Merge PACS.
Applicable verification and
validation testing has been
performed to justify the
safety and efficacy of this
difference from the primary
predicate.


Non-significant changes(s) introduced in subject device Merge PACS:

Yes - Terarecon
embedded in Merge
PACS, opens in same
window

Yes – Terarecon opens in
separate window

Not a clinically significant
difference. End functionality
owned by Terarecon.
Smoother integration with
Merge PACS for user
convenience, but no clinical
impact to the patient.

Automatic
Registration for
series that do
not share a
common frame
of reference

No – Automatic linking of
series with same frame of
reference UID and
manually linking of series
that do not share a
common frame of
reference only

Not a clinically significant
difference for Merge PACS.
Automatic registration is
through the functionality of
Blackford to deliver DICOM
objects to Merge PACS for
automatic registration of
series that do not share a
common frame of
reference. No impact to
safety or effectiveness.

Patient Synopsis
information
within Patient
Record

Similar functionality
– can Integrate with
patient record

Not a clinically significant
different, Watson Imaging
Patient Synopsis provides a
new option for clinicians to
view patient information.


No – user must perform
additional key clicks to go
between 2D and 3D
images

Not a clinically significant
difference. Provides a user
convenience only to more
quickly toggle between
views. No clinical impact to
the patient.

Allow flexibility
in choosing the
desired local,
network (e.g
LDAP), or Merge
PACS accounts
of various user
services

Security enhancements only
and allows for more
customizable controls. No
impact to safety or
effectiveness.

Security
enhancements,
and updates to
graphics in
About Screen

Not a clinically significant
difference. About Screen
provides information only
and security enhancements
have no impact to safety or
effectiveness.


Picture archiving and
communications system

QyScore is intended for automatic
labeling, visualization and
volumetric quantification of
segmentable brain structures and
lesions from a set of MR images.
Volumetric data may be compared to
reference percentile data. QyScore is
not intended for use in clinical
scenarios that require evaluation of
the number of the white matter
hyperintensities.

NeuroQuant is intended for
automatic labeling, visualization and
volumetric quantification of
segmentable brain structures and
lesions from a set of MR images.
Volumetric measurements may be
compared to reference percentile
data.

- Automated measurement of brain
tissue volumes and structures and
lesions
- Automatic segmentation and
quantification of brain structures
using a dynamic probabilistic
neuroanatomical atlas based on the
MR image intensity

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


- Results displayed through graphical
user interface

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

Automated internal pipeline that
performs:
- bias correction
- segmentation
- lesions quantification
- volume calculation
- report generation

MRI scanner: 3DT1 and FLAIR MRI
scans acquired with specified
protocols.
Supports DICOM format as input.

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

Automated quality control function:
scan protocol verification
Results must be reviewed by a
trained physician

Automated quality control functions:
- Tissue contrast check
- Scan protocol verification
- Atlas alignment check
Results must be reviewed by a
trained physician


Classification Name:
Magnetic Resonance Diagnostic Device

Vantage Galan 3T, MRT-3020, V6.0 with
AiCE Reconstruction Processing Unit for
MR


Predicate Device (system): Vantage Galan 3T, MRT-3020/A7, V5.0 (K181593)


Predicate Device:
Vantage Galan 3.0T,
MRT-3020/A7, V5.0

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)

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


Potential emergency
condition and means
provided for
shutdown

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


Shanghai United Imaging Healthcare
Co., Ltd.

Table 1 Substantial equivalent discu
ssion for basic functions

Item
Proposed Device
Predicate Device
Remark

Device Classification
Picture Archiving and Communications
Picture Archiving and Communications
Same

Regulation Number
21 CFR 892.2050
21 CFR 892.2050
Same

Classification Panel
Radiology
Radiology
Same

Advanced Application
Yes
Yes
chapters, tha


Item
Proposed Device
Predicate Device
Remark

complex MRS data. This application
supports the analysis for both SVS
(Single Voxel Spectroscopy) and CSI
(Chemical Shift Imaging) data.
 The MAPs application is intended to
provide a number of arithmetic and
statistical functions for evaluating
dynamic processes and images. These
functions are applied to the grayscale
values of medical images.
 The MR Breast Evaluation application
provides the user a tool to calculate
parameter maps from contrast-
enhanced time-course images.
 The Brain Perfusion application is
intended to allow the visualization of
temporal variations in the dynamic
susceptibility time series of MR
datasets.
 MR Vessel Analysis is intended to
provide a tool for viewing,
manipulating, and evaluating MR
vascular images.


 The Inner view application is intended
to perform a virtual camera view
through hollow structures (cavities),
such as vessels.
 The DCE analysis is intended to view,
manipulate, and evaluate dynamic
contrast-enhanced MRI images.
 The United Neuro is intended to view,
manipulate, and evaluate MR
neurological images.
 The MR Cardiac Analysis application
is intended to be used for viewing,
post-processing and quantitative
evaluation of cardiac magnetic
resonance data.


Optimized
function which
will not impact
the safety and
effectiveness.


Advanced
Function name
Proposed device
Reference Device#1
Remark

Table 2 Substantial equivalent discussion for MR Cardiac Analysis


Reference Device#2
Philips IntelliSpace Cardiovascular
(K153022)

Flow Analysis
Type of imaging scans
MR
MR
Same

Diffusion parameter analysis
Yes
Yes
Same


Feature
Subject Device
Predicate Devices

Assignment of a probability of a
candidate being a coronary
calcification based on location
within the heart, density, shape
and similar properties: if the
probability of a candidate is
higher than a predefined
threshold, the candidate is
labelled as a calcification.
In addition, results of the
evaluation can be sent via Rapid
Results Technology any generic
DICOM viewer.

The technology is equivalent to
HealthCCS:
Assignment of a probability of a
candidate being a coronary
calcification based on location
within the heart, density, shape
and similar properties: if the
probability of a candidate is
higher than a predefined
threshold, the candidate is
labelled as a calcification.

Browsing, selecting, and
displaying images for
searching calcium
regions/lesions

Interactive definition of ROIs
and assignment of the four
major coronary arteries (LM,
LAD,CRC and RCA) to the
lesions

Displaying the score in form
of result tables/reports on
paper and/or film


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
Second Edition 2007-03-01

Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015


Primary:
Aquilion ONE (TSX‐
306A/3) V10.0

JAK:
System, X‐ray,
Tomography,
Computed

Reference:
Aquilion ONE (TSX‐
305A/6) V8.9 with
AiCE

Reference:
Dual Energy System
Package, CSDP‐001A


S
ubject Device
P
redicate Device
C
omment

Model Number
TSX‐306A/3) V10.0 with
TSX‐306A/3) V10.0

5
10(k) Number
T
his submission
K
192188

Spectral Imaging System
(CSDE‐004A)
 Scan Type
 Scan Regions
 Spectral Reconstruction
Images

Available
‐Rapid kV Switching
‐Abdomen and pelvis,
Chest and Extremities
‐Basis material image
‐Monochromatic image
‐Iodine Map
‐VNC (virtual non‐
contrast) image

Reference Predicate
Device: K132813
‐Two consecutive volume
scans with short tube
voltage switching
‐Whole Body
N/A

Advanced Intelligent Clear‐IQ
Engine (AiCE)
 Scan Regions

Available
Abdomen and Pelvis
Chest
Cardiac
Extremities*
Brain*
Inner ear*

Reference Predicate
Device: K183046
Abdomen and Pelvis
Chest
Cardiac
*New scan regions

FIRST
(Forward projected model‐
based Iterative Reconstruction
SoluTion)

Reconstruction processing
unit (CCRS‐003A*)


Aquilion Prime SP,
TSX‐303B/1, v8.4
(Primary Predicate
Device)

Aquilion ONE (TSX‐
305A/6) V8.9 with
AiCE
(Reference Device)


Item
Aquilion Prime SP (TSX‐303B/8)
Aquilion Prime SP (TSX‐303B/1) V8.4

Anatomical Region
AIDR 3D (Whole Body)
AIDR 3D (Whole Body)

AIDR 3D
AIDR 3D Enhanced
Quantum Denoising Smoothing (QDS)

Console CKCN‐017B
Reconstruction processing system
(N/A)

Display console kit
CGS‐72B (Optional)
CGS‐72A: TSX‐303B/1 (Optional)

Image Quality Claims
‐ Improved Quantitative high contrast
No change

Operating System
Microsoft Windows 10
Microsoft Windows 7

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


21 CFR 892.2090
Radiological Computer Assisted
Detection And Diagnosis Software

A concurrent reading aid for
physicians interpreting screening
FFDM acquired with compatible
mammography systems, to identify
findings and assess their level of
suspicion.

Women undergoing FFDM
screening mammography

Predicate and Subject Device Comparison:


Physicians interpreting FFDM
screening mammograms

Design
Software-only device
SAME
Yes, identical

MammoScreen™ is intended for
use as a concurrent reading aid for
interpreting physicians, to help
identify findings on screening
FFDM acquired with compatible
mammography systems and assess
their level of suspicion. Output of
the device includes marks placed on
findings on the mammogram and
level of suspicion scores. The
findings could be soft tissue lesions
or calcifications. The level of
suspicion score is expressed at the
finding level, for each breast and
overall for the mammogram. Patient
management decisions should not
be made solely on the basis of
analysis by MammoScreen™.

The ScreenPoint Transpara™
system is intended for use as a
concurrent reading aid for
physicians interpreting
screening mammograms, to
identify regions suspicious for
breast cancer and assess their
likelihood of malignancy.
Output of the device includes
marks placed on suspicious
soft tissue lesions and
suspicious calcifications;
region‐based scores, displayed
upon the physician’s query,
indicating the likelihood that
cancer is present in specific
regions; and an overall score
indicating the likelihood that
cancer is present on the
mammogram.
Patient management decisions
should not be made solely on
the basis of analysis by
Transpara™.


Finding level:
10-point scale score indicating the
level of suspicion of malignancy
(from low suspicion to high
suspicion).
Breast level:
The same 10-point scale score as
finding level. The score of a breast
is equal to the maximum score of
the findings detected in this breast.
Exam level:
Exam-level of suspicion resulting
directly from the maximum score of
both breasts (1-to-1 mapping
between the score and the exam-
level of suspicion).

Finding level:
Continuous score 1-100
indicating the level of
suspicion of malignancy (from
low suspicion to high
suspicion).
Breast level:
None
Exam level:
10-point scale score indicative
of higher frequency of cancer
positive

Both scores are
substantially
equivalent.
Both scores increase
with the level of
suspicion. The
minimum (resp. the
maximum) of the both
scores describes the
same status.
At the Exam level,
both scores have a 10-
point scale.

Findings are by-default displayed
when score is equal or higher to 5.
Upon user request for findings of
score equal or less to 4.

Upon user request by clicking
in a position of the image also
detected by TransparaTM.

Both are the
demonstration of the
same intention:
reducing the number
of findings the user
has to review. In this
sense, both are
equivalent.


Reader study:
- 240 cases
- 14 radiologists
Reading time (two sessions mean):
- 57,67 seconds (unaided
session)
- 64, 13 seconds (with
MammoScreen)
AUC:
- radiologists AUC
(unaided) = 0,769
- standalone AUC = 0,786

Reader study:
- 240 cases
- 14 radiologists
Reading time:
- 146 seconds (unaided
session)
- 149 seconds (with
Transpara™)
AUC:
- radiologists AUC
(unaided) = 0,866
- standalone AUC =
0,887

Despite a slightly
higher performance of
MammoScreen
compared to
Transpara™, gains
are still comparable
and do not raise new
questions regarding
safety and
effectiveness of the
device.

Distinguishes two types of
suspicious findings (calcifications
and soft tissue lesions).
The CAD output provided by the
server includes the location and the
outline of findings.
MammoScreen processing server is
a standalone system WITH a user
interface.

Distinguishes two types of
suspicious findings
(calcifications and soft tissue
lesions).
The CAD output provided by
the server includes the location
and the outline of findings.
Transpara™ processing server
is a standalone system
WITHOUT a user interface.

Despite some
differences between
the predicate device
and MammoScreen,
features are still
comparable and do
not raise new
questions regarding
safety and
effectiveness of the
device.


In MammoScreen, a range of
medical image processing and
machine learning techniques are
implemented. The system includes
‘deep learning’ modules for
recognition of suspicious
calcifications and soft tissue
lesions. These modules are trained
with very large databases of biopsy-
proven examples of breast cancer
and normal tissue.


acquired on GE® devices, are given in the table below:


comparison with FFDM acquired on GE® devices, are given in the table below:


5.3.1.1 Filtering of findings) and corresponding to MammoScreen scores 1, 3 and 5 respectively.


position Suspicion shown) Suspicion hidden) hidden)


Figure 7.5: LR
OC (
left) an
d FROC
(right)
curves
on US soft
tissu
e lesion
s only.


FOM MS1 MS2 MS3 MS4 MS5 MS6 MS7 MS8 MS9 MS10


Item
InferRead Lung CT.AI
ClearRead CT (K161201)
Comparison

InferRead Lung CT.AI is
comprised of computer
assisted reading tools
designed to aid the
radiologist in the detection
of pulmonary nodules

ClearRead CT™ is
comprised of computer
assisted reading tools
designed to aid the
radiologist in the detection of
pulmonary nodules during

The indications for use of InferRead Lung
CT.AI are identical to the indications for
use of the previously cleared ClearRead
CT.

Detailed Comparison of the Subject and Predicate Devices


during the review of CT
examinations of the chest on
an asymptomatic population.
InferRead Lung CT.AI
requires that both lungs be
in the field of view.
InferRead Lung CT.AI
provides adjunctive
information and is not
intended to be used without
the original CT series.

review of CT examinations
of the chest on an
asymptomatic population.
The ClearRead CT requires
both lungs be in the field of
view. ClearRead CT provides
adjunctive information and is
not intended to be used
without the original CT
series.

Computer assisted reading
tools designed to aid the
radiologist in the detection
of pulmonary nodules
during review of CT
examinations of the chest.

The intended use of InferRead Lung
CT.AI is identical to the intended use of
the previously cleared ClearRead CT.

Accessories/Tools
Required by the
User (Platform)

Must be used in conjunction
with a PACS system or an
Image Viewer that reads
DICOM images.

The accessories required by the user for
InferRead Lung CT.AI are identical to the
accessories required by the user for the
previously cleared ClearRead CT.

The user access point of InferRead Lung
CT.AI is identical to the user access point
of the previously cleared ClearRead CT.

The image input of InferRead Lung CT.AI
is identical to the image input of the
previously cleared ClearRead CT.

The type of scans for InferRead Lung
CT.AI are identical to the type of scans for
the previously cleared ClearRead CT.

Automatically
Locate and
Identify Lung
Nodules

The function of automatically locating and
identifying lung nodules for InferRead
Lung CT.AI is identical to the function of
automatically locating and identifying


lung nodules for the previously cleared
ClearRead CT.

According to the device description of the
predicate device found in its 510K
summary, “ClearRead CT is a dedicated
post-processing application that generates
a secondary vessel suppressed Lung CT
series with CADe marks and associated
region descriptors intended to aid the
radiologist in the detection of pulmonary
nodules.” ClearRead CT modifies the
original scan by performing vessel
suppression. On the contrary, InferRead
Lung CT.AI does not modify the original
scan, only shows the locations of
pulmonary nodules.
This difference does not affect the
intended use or safety and effectiveness of
the device.

Requires a
Disjoint
Comparison with
the Original CT
Scan

Since ClearRead CT creates a secondary
vessel suppressed Lung CT series, it
requires the user to have an original CT
series on a separate window. There are 2
series open at the same time. We refer to
this setup as “disjoint comparison”. On the
contrary, InferRead Lung CT.AI does not
require 2 series open, as its CADe marks
overlay with the original CT scan and can
be toggled on and off. Therefore,
InferRead Lung CT.AI does not require
“disjoint comparison”
This difference does not affect the
intended use or safety and effectiveness of
the device. CT scans processed by


InferRead Lung CT.AI display the original
CT scans.

A bounding box is provided
around nodules

The function of providing a bounding box
around nodules for InferRead Lung CT.AI
is identical to the indications for use of the
previously cleared ClearRead CT.

Yes, the maximum axial
plane longest diameter,
mean diameter and volume
information are provided.

Yes, the volume, maximum
axial plane diameter,
minimum axial plane
diameter, and average
density in Hounsfield units
are provided. (from website)

InferRead Lung CT.AI has mean diameter
measurement function that is not provided
by predicate device. Mean diameter is the
average of maximum axial plane diameter
and minimum axial plane diameter. And
this difference does not affect the safety
and effectiveness of the device.

Solid, Sub Solid (part solid
and ground glass) nodules

The detection targets of InferRead Lung
CT.AI are identical to the detection targets
of the previously cleared ClearRead CT.
They have the same definition principles
for actionable nodules classification.

4mm and above, supports
visualization of nodules
smaller than 4mm

5mm and above, supports
visualization of nodules
smaller than 5mm

The InferRead Lung CT.AI detects smaller
nodules. This difference does not affect
the intended use or safety and
effectiveness of the device. This difference
has been addressed with the completion of
stand-alone performance characteristics
testing.


Radiological Computer-Assisted Prioritization Software

The HealthVCF device is substantially equivalent to the following device:


suggestive of the presence
of at least one vertebral
compression at the exam
level. These flags are
viewed by the clinician in
Bone Health and Fracture
Liaison Service programs
in the medical setting via
a worklist application on
their Picture Archiving
and Communication
System (PACS).
HealthVCF does not send
a proactive alert directly
to the user.
HealthVCF does not
provide diagnostic
information beyond triage
and prioritization, it does
not remove cases from the
radiology worklist, and
should not be used in
place of full patient
evaluation, or relied upon
to make or confirm
diagnosis.

exam level. These flags are
viewed by the radiologist via
their Picture Archiving and
Communication System
(PACS) worklist. The
decision to use cmTriage
codes and how to use
cmTriage codes is ultimately
up to the radiologist.
cmTriage does not send a
proactive alert directly to the
radiologist. Radiologists are
responsible for reviewing
each exam on a diagnostic
viewer according to the
current standard of care.
cmTriage is limited to the
categorization of exams, does
not provide any diagnostic
information beyond triage
and prioritization, does not
remove images from the
radiologist’s worklist, and
should not be used in lieu of
full patient evaluation, or
relied upon to make or
confirm diagnosis. cmTriage
is for prescription use only.

Notification-only,
parallel workflow
tool

Different, but both
users include a
“designated list of
clinicians” per 21
CFR 892.2080

Identify patients
with prespecified
clinical condition

Different but both
findings suggestive of
a pre-specified clinical
condition

Independent of
standard of care
workflow

Different, but both run
on “radiological


Different anatomical
sites but both
“operates on
radiological images of
the human body” per
21 CFR 892.2080.

Aids prompt
identification of
cases with
indicated findings


Kolonel Begaultlaan 1b/12
3012 Leuven
Belgium


Common Name
Medical Image Processing Software

Classification Name
System, Image processing, Radiological


Device to market
Proposed predicate device
Proposed Reference device

Picture archiving and communications system

icometrix NV
Kolonel Begaultlaan 1b / 12
3012 Leuven
BELGIUM

Viz.ai, Inc.
855 El Camino Real Suite 13A-252
Palo Alto, CA 94301

iSchemaView, Inc.
323 Olmsted Road
Stanford, CA 94305

icobrain ctp is an image processing
software package to be used by
trained professionals, including but
not limited to physicians and
medical technicians. The software
runs on a standard "off-the-shelf"
computer or a virtual platform,
such as VMware, and can be used
to perform image processing,
analysis, and communication of
computed tomography (CT)
perfusion scans of the brain. Data
and images are acquired through
DICOM-compliant imaging devices.
icobrain ctp provides both analysis
and communication capabilities for
dynamic imaging datasets that are
acquired with CT Perfusion imaging
protocols. Analysis includes
calculation of parameters related to
tissue flow (perfusion) and tissue
blood volume. Results of image
processing which include CT
perfusion parameter maps
generated from a raw CTP scan are
exported in the standard DICOM
format and may be viewed on
existing radiological imaging viewers.

Viz CTP is an image processing software
package to be used by trained professionals,
including but not limited to physicians and
medical technicians. The software runs on a
standard "off-the-shelf" computer or a virtual
platform, such as VMware, and can be used
to perform image processing, analysis, and
communication of computed tomography
(CT) perfusion scans of the brain. Data and
images are acquired through DICOM-
compliant imaging devices.
Viz CTP provides both analysis and
communication capabilities for dynamic
imaging datasets that are acquired with CT
Perfusion imaging protocols. Analysis
includes calculation of parameters related to
tissue flow (perfusion) and tissue blood
volume. Results of image processing which
include CT perfusion parameter maps
generated from a raw CTP scan are
exported in the standard DICOM format
and may be viewed on existing radiological
imaging viewers.

iSchemaView's RAPID is an image
processing software package to be used
by trained professionals, including but not
limited to physicians and medical
technicians. The software runs on a
standard "off-the-shelf" computer or a
virtual platform, such as VMware, and can
be used to perform image viewing,
processing and analysis of brain images.
Data and images are acquired through
DICOM compliant imaging devices.
iSchemaView's RAPID provides both
viewing and analysis capabilities for
functional and dynamic imaging datasets
acquired with CT Perfusion and MRI
including a Diffusion Weighted MRI
(DWl) Module and a Dynamic Analysis
Module (dynamic contrast enhanced
imaging data for MRI and CT).


Standard "off-the-shelf" computer
or a virtual platform.

icobrain ctp is a software package
that provides for the quantification
and visualization of the perfusion of
tissue based on dynamic contrast
enhanced CT images.

Automatic analysis for functional and
dynamic imaging datasets acquired with
CT Perfusion and MRI including a
Diffusion Weighted MRI (DWl) Module
and a Dynamic Analysis Module (dynamic
contrast enhanced imaging data for MRI
and CT).

Acquires medical image data from
DICOM compliant imaging devices
and modalities.

Perfusion CT
Cerebral Blood Flow (CBF)
Yes
Yes

Tissue residue function time to
peak (TMax)

Arterial Input Function (AIF) /
Venous Output Function (VOF)

Export perfusion files to PACS and
DICOM file systems

Acquire, transmit, process, and
store medical images