Analyzes Air Trapping
Index by registration of
inspiration and
expiration data. Could
compare both IN/EX
after the registration

Imbio provides
segmentation of lung
and automatied
registration of
inspiration and
expiration image part to
classify the analysis by
thresholding the CT
data.
It also provides an
interctive visualliztion
of the registered pairs to
analyze low-density
cluster (air trap) and
airway analysis.

Fully automatic
INSP/EXP registration
(non-rigid elastic)
algorithm.

Uses advanced image
processing techniques
to spatially “register”
two CT image of the
lungs.

Fully automatic
lung/lobe segmentation
using deep-learning
algorithms

Automatic calculation of
measurements for each
segmented nodule
 Size of the Major axis
and Minor axis(mm)
 Diameter of Major
(3D), 2nd Major
(3D), Major(2D),
Minor(2D) (mm)
 Volume(mm³)
 Max, Min, Mean HU
of the nodule((HU)
Cancer probability (%)

Comparison and
matching automatic
calculations between
each follow-up scan and
the baseline scan
 Doubling time in
days
 Indicated the change
of the size
Auto generate Lung-
RADS

Workflow
 Detect and Segment
 Comparison and
Matching
 Results
Option to integrate with
3rd party CAD which
automatically detects the
nodules and generate
report

Reporting results
The results include the
following;
 Lung-RADS
 PANCAN risk
calculator
 Auto detect nodule
location by lobe


4309 Emperor Blvd., Suite 310
Durham, NC 27703, USA

Patrick Willhite
Director of Quality Assurance and Regulatory Affairs

Email: pwillhite@terarecon.com
Phone: 919.670.1539
Facsimile: 650.372.1101


Proprietary (Trade) Name:
Neuro.AI Algorithm (“Neuro.AI”)

§ 892.2050, Picture Archiving and Communication
System.

LLZ – System, Image Processing, Radiological


Vendor-neutral - CT, MR and
other volumetric imaging
modalities. Images are
exposed over time.

Vendor-neutral - CT, MR,
Nuc, PET, Angio, US/Echo,
SPECT, CR/DR Review

Microsoft
Windows® executable on
off-the-shelf hardware

Head – entire brain or from
lower edge of the base of
nucleus to upper edge of the
ventricles.

Head and other regions and
organs within the body

 2D, 3D and 4D viewing,
multi-phase series
support, zoom, pan,
window level, rotate, cine
and display layouts and
templates
 ROI Markers: Ability to
create preset shapes or
freehand ROI for
measurements or
segmentations
 Arterial and venous input
function selection,
automatic and manual
 Ventricle segmentation

Setting allows software to
display maps with or
without brain ventricles
included

This device is a module of
iNtuition. When used with
iNtuition, the segmentation
tools can be applied to any
part of the body, including
brain ventricles.

Editing and segmentation
tools are provided
including freehand crop,
cut, dynamic region grow,
bone removal tools, rib
cage removal, table
removal tools, and tools to
provide an initial selection
of bone or air-filled vessels
(e.g. lung or colon) for
removal or improvement.
Any segmentation can be
displayed or hidden and
this is applicable for any

TABLE 1: TECHNOLOGICAL CHARACTERISTICS COMPARISON


part of the body, including
brain ventricles.

 Time to Peak (TTP)
 Take off Time (TOT or
Maximum Slope of
Increase)
 Recirculation Time (RT)
 Mean Transit Time (MTT)
 Blood Volume (BV/CBV)
 Blood Flow (BF/CBF)
 Perfusion Maps

Artery and Vein Fitted and
Raw curves –time/activity

Arterial and
Venous Input
Function
Selection

 CT and MR Scanners
 Third-party hospital
systems such as a PACS
server, EMR or other
 iNtuition Advanced
Visualization system
 Algorithm dockerization
using DockerTM hosted in
TeraRecon’s EnvoyAI platf
orm and viewed by

 CT and MR Scanners
 Third-party hospital
systems such as PACS
server, EMR or other
 iNtuition advanced
visualization system

 CT and MR Scanners
plus other imaging
modalities
 Third-party hospital
systems such as PACS
server, EMR or other


Northstar AI Results
Explorer
 Other image viewing
systems that can support
DICOM results generated
by the Neuro.AI Algorithm
 Notification systems


Comparison Feature
QuantX (DEN170022)
Rapid ASPECTS

QuantX is a computer-aided
diagnosis (CADx) software
device used to assist radiologists
in the assessment and
characterization of breast
abnormalities using MR image
data. The software automatically
registers images and segments
and analyzes user-selected
regions of interest (ROI). QuantX
extracts image data from the ROI
to provide volumetric analysis
and computer analytics based on
morphological and enhancement
characteristics. These imaging (or
radiomic) features are then
synthesized by an artificial
intelligence algorithm into a
single
value, the QI score, which is
analyzed relative to a database of
reference abnormalities with
known ground truth.
QuantX is indicated for
evaluation of patients presenting
for high-risk screening, diagnostic
imaging workup, or evaluation of
extent of known disease. Extent
of known disease refers to both
the assessment of the boundary of
a particular abnormality as well as
the assessment of the total disease
burden in a particular patient. In
cases where multiple
abnormalities are present, QuantX
can be used to assess each
abnormality independently.
This device provides information
that may be useful in the
characterization of breast
abnormalities during image
interpretation. For the QI score
and component radiomic features,
the QuantX device provides
comparative analysis to lesions

Rapid ASPECTS is a computer-
aided diagnosis (CADx) software
device used to assist the clinician in
the assessment and characterization
of brain tissue abnormalities using
CT image data. The Software
automatically registers images and
segments and analyzes ASPECTS
Regions of Interest (ROIs). Rapid
ASPECTS extracts image data for
the ROI(s) to provide analysis and
computer analytics based on
morphological characteristics. The
imaging features are then
synthesized by an artificial
intelligence algorithm into a single
ASPECT (Alberta Stroke Program
Early CT) Score.
Rapid ASPECTS is indicated for
evaluation of patients presenting for
diagnostic imaging workup, or
evaluation of extent of disease.
Extent of disease refers to the
number of ASPECTS regions
affected which is reflected in the
total score.
This device provides information
that may be useful in the
characterization of early ischemic
brain tissue injury during image
interpretation. Rapid ASPECTS
provides a comparative analysis to
the ASPECTS standard of care
radiologist assessment using the
ASPECTS atlas definitions and
atlas display including highlighted
ROIs and numerical scoring.
Limitations:
1.Rapid ASPECTS is not intended
for primary interpretation of CT
images. It is used to assist physician
evaluation.
2.Rapid ASPECTS has been
validated in patients with known
MCA or ICA occlusion prior to
ASPECT scoring.


with known outcomes using an
image atlas and histogram display
format.
QuantX may also be used as an
image viewer of multi-modality
digital images, including
ultrasound and mammography.
The software also includes tools
that allow users to measure and
document images, and output in a
structured report.
Limitations: QuantX is not
intended for primary
interpretation of digital
mammography images.

3. Use of the Rapid ASPECTS
Module in clinical settings other than
early brain ischemia (within 6 hours)
caused by known ICA or MCA
occlusions has not been tested.
4. Rapid ASPECTS has been
validated and is intended to be used
on GE Lightspeed VCT Scanners.
Contraindications/Exclusions/Cautio
ns:
• Patient Motion: excessive motion
leading to artifacts that make the
scan technically inadequate.
• Hemorrhagic Transformation,
Hematoma
• Very thin or no Ventricles

ASPECTS Atlas ROIs, highlighted
by algorithms.

Primary User(s)
Radiologist
Neuroradiologist/Clinician


This device provides a systematic, automated analysis of
NCCT scans of the head to provide a standardized, automated
ASPECT score for Stroke workup. The clinical reader study,
which included 2 expert neuroradiologists and 6 non-expert
typical readers demonstrated a statistically significant
improvement in the accuracy of the 8 readers’ scores when
scoring was performed in conjunction with the Rapid
ASPECTS output. In a subgroup analysis, the benefit of the
software was most substantial among the non-neuroradiologist
readers which typically evaluate CT scans in community
hospitals and primary stroke centers. These non-expert
readers also evaluate CT scans in comprehensive centers,
particularly in the acute setting, when expert neuroradiologists
are not immediately available. The software allows the non-
expert physician to perform at the expert-like level. Use of the
system did not appear to have any significant impact (either
positive or negative) on the scores of the 2 expert
neuroradiologists who were included in the test reader group.
Overall this system should provide a more consistent and
timely benefit of standardized reads regardless of physician
and center specialty.

There are minimal potential risks associated with the use of
the device.

Incorrect scoring which may result in false positive
results and result to incorrect patient management with
possible adverse effects such as, unnecessary additional
medical imaging and/or unnecessary additional
diagnostic workup.

Incorrect scoring which may result in false negative
results may lead to complications, including incorrect
diagnosis and delay in disease management.

The device could be misused to analyze images from an
unintended patient population or on images acquired
with incompatible imaging hardware or incompatible
image acquisition parameters, leading to inappropriate
diagnostic information being displayed to the user.

Device failure could lead to the absence of results, delay of
results or incorrect results, which could likewise lead to
inaccurate patient assessment.

However, based on the performance data and the
application of mitigating measures (general controls and
special controls established for this device type), use of


the device is unlikely to decrease diagnostic
performance of the user and possible misuse of the
device does not present additional risks compared with
misuse of other types of radiological image processing
devices.

The study was enriched to cover the range of ASPECT scores;
and, the readers in practice may not experience a significant
improvement in determining ASPECTS.

Conclusions: Do the
probable benefits
outweigh the probable
risks.

Yes. The probable benefits outweigh the probable risks, given
the combination of required general controls and the special
controls established for this device. The Special Controls
will sufficiently assist in managing risks associated with
incorrect brain tissue characterization determining
ASPECT scoring, application of the device results to the
wrong patient population, analysis of incompatible images,
and/or device failure by ensuring proper performance and
use of the device
By providing a systematic, automated analysis of NCCT scans
of the head to provide a standardized, automated ASPECT
score for Stroke workup. The Rapid ASPECTS analytics
calculates morphological characteristics of brain tissue using
the historical training data and providing results which the
attending physician may evaluate and modify based on other
presenting conditions of the patient. In addition to the Rapid
ASPECTS clinical module, other clinical information is easily
accessible within the Rapid System framework such as CTA
and CTP to inform the clinical decision-making process.
The clinical reader study demonstrates a statistically
significant improvement of ASPECTS reads among a diverse
sample of 8 typical readers representing multiple specialties,
years of practice, and practice settings.
By using a gating condition of LVO determination to guide
ASPECTS use, many of the risks of stroke mimics
confounding the scoring will be averted.
Overall this system should provide a more consistent and
timely benefit of standardized reads regardless of physician
and center specialty. Therefore, given the available
information concerning the benefits, risks, and supporting
data; the probable benefits outweigh the probable risks,
given the combination of required general controls and
special controls established for this device.


Prevalence
CINA - ICH triage application
CINA - LVO triage application

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


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


Predicate device: Aidoc BriefCase
Software (K180647)

Reference device: Viz.AI ContaCT
software (DEN170073)

CINA is a radiological computer
aided triage and notification
software indicated for use in the
analysis of (1) non-enhanced head
CT images and (2) CT
angiographies of the head.
The device is intended to assist
hospital networks and trained
radiologists in workflow triage by
flagging and communicating
suspected positive findings of (1)
head CT images for Intracranial
Hemorrhage (ICH) and (2) CT
angiographies of the head for large
vessel occlusion (LVO).
CINA uses an artificial intelligence
algorithm to analyze images and
highlight cases with detected (1)
ICH or (2) LVO on a standalone
Web application in parallel to the
ongoing standard of care image
interpretation. The user is presented
with notifications for cases with

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

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

Table 3: Comparison of key features between CINA and predicate device (Aidoc BriefCase) and reference device (Viz.AI ContaCT)


suspected ICH or LVO findings.
Notifications include compressed
preview images that are meant for
informational purposes only, and are
not intended for diagnostic use
beyond notification. The device does
not alter the original medical image,
and it is not intended to be used as
a diagnostic device.
The results of CINA are intended to
be used in conjunction with other
patient information and based on
professional judgment to assist with
triage/prioritization of medical
images. Notified clinicians are
ultimately responsible for reviewing
full images per the standard of care.

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

be previewed through a mobile
application.
Images that are previewed through
the mobile application are
compressed and are for informational
purposes only and not intended for
diagnostic use beyond notification.
Notified clinicians are responsible for
viewing non-compressed images on
a diagnostic viewer and engaging in
appropriate patient evaluation and
relevant discussion with a treating
physician before making care-related
decisions or requests. ContaCT is
limited to analysis of imaging data
and should not be used in-lieu of full
patient evaluation or relied upon to
make or confirm diagnosis.

Clinician (e.g., neurovascular
specialist)

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


DICOM information about the
patient, study and current image

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

Artificial intelligence algorithm with
database of images

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

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

Structure
- LVO and ICH image processing
- AHS module (image acquisition),
- Image Forwarding Software


Predicate device: Aidoc BriefCase
Software (K180647)

Reference device: Viz.AI ContaCT
software (DEN170073)

applications
- CINA Platform (worklist and Image
Viewer)

- ACS module (image processing),
- Aidoc Worklist application for
workflow integration (worklist and
Image Viewer).

- Image Processing and Analysis
Software
- Non-diagnostic DICOM viewing
mobile application


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

Artificial intelligence
algorithm with
database of images

The software sends a
notification to the
specialist identifying
the study of interest.
Additionally, the
device also provides a
DICOM viewing
mobile application
allow users preview
the images.

The software sends a
notification email to
the specialist
identifying the study
of interest.
Additionally, the
device provides user
with a link to DICOM
Web viewer allowing
users review the
images.

Notification time is
defined as the time
from CTA to
notification.

Independent of
standard of care
workflow

currently marketed and predicate device ContaCT are summarized below.


Radiological Computer-Assisted Prioritization Software

The HealthMammo device is substantially equivalent to the following device:


make or confirm diagnosis. The
HealthMammo device is
intended for use with complete
2D FFDM mammography
exams acquired using validated
FFDM systems only.

diagnosis. cmTriage is for
prescription use only.

Notification-only,
parallel workflow
tool

User
Interpreting physician
Radiologist
Same

Identify patients with
prespecified
clinical condition

Yes; passive notification
flagged for review

Modality
FFDM screening mammograms
FFDM screening mammograms
Same

Different, the
subject device
processes 2D
FFDM scans
acquired by
Hologic systems,
while the predicate
device may receive
scans acquired from
alternative vendors.

- 2D FFDM screening
mammograms
- Biopsy proven cancer studies
(soft tissues and micro-
calcifications)
- BIRADS 1 and 2 normal
cases with 2 year follow-up
Studies with 4 standard views
(LCC, LMLO, RCC, RMLO)

- Studies that do not include all
4 views


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

Aids prompt
identification of
cases with indicated
findings

Different,
HealthMammo
provides an
additional 2
operating points.
Performance
complies with DEN
170073 Special
control 1(iii).

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


Parameter
qER Device
Aidoc Briefcase Software

qER is a radiological computer aided triage and
notification software indicated for use in the
analysis of non-contrast head CT images.
The device is intended to assist hospital networks
and trained medical specialists in workflow triage
by flagging the following suspected positive
findings of pathologies in head CT images:
intracranial hemorrhage, mass effect, midline shift
and cranial fracture.
qER uses an artificial intelligence algorithm to
analyze images on a standalone cloud-based
application in parallel to the ongoing standard of
care image interpretation. The user is presented
with notifications for cases with suspected
findings. Notifications include non-diagnostic
preview images that are meant for informational
purposes only. The device does not alter the
original medical image and is not intended to be
used as a diagnostic device.
The results of the device 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 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 professional judgment, to assist
with triage/prioritization of medical images.
Notified clinicians are responsible for viewing full
images per the standard of care.

1. An on-premise module that:
a. Performs de-identification of studies and pushes
them to the cloud module.
b. Receives results after processing on the cloud
module.
c. Re-identifies the studies and sends them to the
radiology PACS and radiology worklist.
2. A cloud module that performs the analysis using
a pre-trained artificial intelligence algorithm.

Table 1. Comparison of Technical Characteristics with Predicate Device


DICOM Information about the patient, study and
current image

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

Artificial intelligence algorithm with database of
images.

Yes, with controls for the user to select the finding
or combination of findings for triage

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

Four findings: Intracranial haemorrhage, Mass
effect, midline shift, cranial fracture and ICH

Triages non-contrast CT scan when any of the 4
abnormalities are identified
Notification/ prioritization with user provided
control for configuring the triage finding or
combination of finding(s)

Non contrast CT scan of the head or neck
Single configuration

Preview images returned to the PACS
Preview images are reduced in size and their
dynamic range is limited

Preview images on hover over the worklist
Preview images are compressed and/or reduced
in size


Table 2. Primary Endpoint Results in qER Standalone Performance Study


Time to open exam in
the standard of care

Containing One of the Target Abnormalities


Philips Ultrasound, Inc.
Traditional 510(k)
Page 1 of 8


Philips Ultrasound, Inc.
Traditional 510(k)
Page 2 of 8


Classification Description
21 CFR Section
Product CCode

Automated Radiological Image Processing Software


Philips Ultrasound, Inc.
Traditional 510(k)
Page 3 of 8


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Philips Ultrasound, Inc.
Traditional 510(k)
Page 8 of 8


Classification Name
Regulation Number
Product Code

Ultrasonic Pulsed Echo Imaging System
21 CFR 892.1560
IYO

Diagnostic Ultrasound Transducer
21 CFR 892.1570
ITX


Comparison Category
Butterfly Auto 3D
Predicate Verathon

Bladder Volume Tool
BladderScan Prime PLUS

The Butterfly Auto 3D
Bladder Volume Tool is a
software application
package. It is designed to
view, quantify and report
results acquired on Butterfly
Network ultrasound
systems for noninvasive
volume measurements of
the bladder, to support
physician diagnosis.
Indicated for use in adult
populations.

The BladderScan Prime
System is an ultrasound
device intended to be used for
measuring the urine volume in
the bladder non- invasively.

The Auto 3D Bladder
Volume Tool is not
intended for fetal or
pediatric use or for use on
pregnant patients, patients
with ascites, or patients
with open skin or wounds
in the suprapubic region.

The BladderScan Prime
System is not intended for fetal
use or for use on pregnant
patients, patients with ascites,
or patients with open skin or
wounds in the suprapubic
region.

Target Population
Male and Female
Male, Female, and Pediatric

Anatomical Site
Identical to predicate
Bladder

marketed predicate device are provided in the table below:


Technological Characteristics and Performance

Technology
Identical to predicate
Neural network technology

Sterility
Identical to predicate
Non-sterile

Power Source
Identical to predicate
Battery powered

Energy Delivered
Identical to predicate
Ultrasound

Measurement Range
0 to 740 mL
0 to 999 mL

Electronic Sector Scanning
(Phased Array)

Touchscreen Operation
Identical to predicate
Yes

Selectable Unit Orientation
(Patient Right/Left)

Live Scan Image
Identical to predicate
Yes

Calibration
Identical to predicate
No calibration recommended


VIDA Diagnostics, Inc.
500 Crosspark Rd.
W250 BioVentures Center
Coralville, IA 52241 USA

Alex Morris, Director, Quality and Regulatory
VIDA Diagnostics, Inc.
2500 Crosspark Rd.
W250 BioVentures Center
Coralville, IA 52241 USA
Cell Phone: (647) 470.4363
Office Phone: (855) 900.8432
Email: amorris@vidalung.ai

Medical Imaging Software for Computed Tomography Devices

Pulmonary Workstation 2 (PW2) by VIDA Diagnostics Inc.
Regulation: 21 CFR 892.1750
Product Code: JAK
Regulatory Class: Class II
Regulation Description: Computed tomography x-ray system
Submission Number: K083227


Manufacturer
510(k) Submitter
Predicate
Differences

VIDA Diagnostics, Inc.
VIDA Diagnostics, Inc.

VIDA|vision (formerly VIDA
Pulmonary Workstation 2
(PW2))

The VIDA|vision software
provides reproducible CT
values for pulmonary tissue,
which is essential for
providing quantitative
support for diagnosis and
follow up examinations.
VIDA|vision can be used to

The VIDA Pulmonary
Workstation 2 (PW2)
software provides
reproducible CT values for
pulmonary tissue, which is
essential for providing
quantitative support for
diagnosis and follow up
examinations. The PW2 can


Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined
(B+Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal,
Peripheral Vessel, Carotid, Cardiac. Lumify is a transportable ultrasound system intended for use in environments where
healthcare is provided by healthcare professionals.

Philips EPIQ
Diagnostic
Ultrasound
System

The intended use of the EPIQ, EPIQ 5, EPIQ 7 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow
analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac
Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular),
Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral
Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.
The clinical environments where the EPIQ Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical
point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during
treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating
instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated
in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Philips Affiniti
Diagnostic
Ultrasound
System

The intended use of the Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging
and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other
(Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic
(Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional),
Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle),
Transesophageal (Cardiac), Transrectal, Transvaginal.
The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical
point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during
treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.


The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating
instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated
in the user information reduces your responsibility for sound clinical judgement and best clinical procedure

Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including
Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics
(Tissue and Contrast) modes.
It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative
Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal
Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including
Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics
(Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological
Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel

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

Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices Page 5 of 19


Philips Lumify Ultrasound System
K# Pending
(Subject Device)

Philips Lumify Diagnostic Ultrasound
System is intended for diagnostic
ultrasound imaging in B (2D), Color
Doppler, Combined (B+Color), and M
modes. It is indicated for diagnostic
ultrasound imaging and fluid flow
analysis in the following applications:
Fetal/Obstetric, Abdominal, Pediatric,
Cephalic, Urology, Gynecological,
Cardiac Fetal Echo, Small Organ,
Musculoskeletal, Peripheral Vessel,
Carotid, Cardiac. Lumify is a
transportable ultrasound system
intended for use in environments where
healthcare is provided by healthcare
professionals.

Duration of Use
Limited (≤ 24 hours)
Limited (≤ 24 hours)
Identical

Scientific
Ultrasound Imaging
Ultrasound Imaging
Identical

Compatible device generates electrical
current and sends to a connected,
compatible transducer to stimulate its
piezoelectric elements at the distal end.

Table 1: Technological Comparison of Subject Device (i.e., Philips Lumify Diagnostic Ultrasound System) & Predicate Device


Stimulation causes the elements to
expand and contract which creates a
high-pressured wave (i.e., soundwave). A
series of soundwaves then propagate
toward tissue medium (e.g., mucus
membrane, bone). The transducer then
receives echoed soundwaves that are
reflected from the tissue medium and
transmits it to the system. The system
processes the echoed soundwaves into
an image which is displayed on the
display monitor screen of the system for
user interpretation.

Biocompatibility
ISO 10993-1
ISO 10993-1
Identical


Philips EPIQ Diagnostic Ultrasound
System Series
K# Pending
(Subject Device)

The intended use of the EPIQ, EPIQ 5,
EPIQ 7 Diagnostic Ultrasound Systems
is diagnostic ultrasound imaging and
fluid flow analysis of the human body
with the following Indications for Use:
Abdominal, Cardiac Adult, Cardiac other
(Fetal), Cardiac Pediatric, Cerebral
Vascular, Cephalic (Adult), Cephalic
(Neonatal), Fetal/Obstetric,
Gynecological, Intraoperative (Vascular),
Intraoperative (Cardiac), Musculoskeletal
(Conventional), Musculoskeletal
(Superficial), Other: Urology, Pediatric,
Peripheral Vessel, Small Organ (Breast,
Thyroid, Testicle), Transesophageal
(Cardiac), Transrectal, Transvaginal.
The clinical environments where the
EPIQ Diagnostic Ultrasound Systems
can be used include Clinics, Hospitals,
and clinical point-of-care for diagnosis of
patients.
When integrated with Philips
EchoNavigator, the systems can assist
the interventionalist and surgeon with
image guidance during treatment of


cardiovascular disease in which the
procedure uses both live X-ray and live
Echo Guidance.
The systems are intended to be installed,
used, and operated only in accordance
with the safety procedures and operating
instructions given in the product user
information, and only for the purposes
for which it was designed. However,
nothing stated in the user information
reduces your responsibility for sound
clinical judgement and best clinical
procedure.

System console generates electrical
current and sends to a connected,
compatible transducer to stimulate its
piezoelectric elements at the distal end.
Stimulation causes the elements to
expand and contract which creates a
high-pressured wave (i.e., soundwave). A
series of soundwaves then propagate
toward tissue medium (e.g., mucus
membrane, bone). The transducer then
receives echoed soundwaves that are


reflected from the tissue medium and
transmits it to the system. The system
processes the echoed soundwaves into
an image which is displayed on the
display monitor screen of the system for
user interpretation.


Philips Affiniti Diagnostic
Ultrasound System Series
K# Pending
(Subject Device)

The intended use of the Affiniti 30,
Affiniti 50 and Affiniti 70 Diagnostic
Ultrasound Systems is diagnostic
ultrasound imaging and fluid flow
analysis of the human body with the
following Indications for Use:
Abdominal, Cardiac Adult, Cardiac other
(Fetal), Cardiac Pediatric, Cerebral
Vascular, Cephalic (Adult), Cephalic
(Neonatal), Fetal/Obstetric,
Gynecological, Intraoperative (Vascular),
Intraoperative (Cardiac), Musculoskeletal
(Conventional), Musculoskeletal
(Superficial), Other: Urology, Pediatric,
Peripheral Vessel, Small Organ (Breast,
Thyroid, Testicle), Transesophageal
(Cardiac), Transrectal, Transvaginal.
The clinical environments where the
Affiniti Diagnostic Ultrasound Systems
can be used include Clinics, Hospitals,
and clinical point-of-care for diagnosis of
patients.
When integrated with Philips
EchoNavigator, the systems can assist
the interventionalist and surgeon with


image guidance during treatment of
cardiovascular disease in which the
procedure uses both live X-ray and live
Echo Guidance.
The systems are intended to be installed,
used, and operated only in accordance
with the safety procedures and operating
instructions given in the product user
information, and only for the purposes
for which it was designed. However,
nothing stated in the user information
reduces your responsibility for sound
clinical judgement and best clinical
procedure.

System console generates electrical
current and sends to a connected,
compatible transducer to stimulate its
piezoelectric elements at the distal end.
Stimulation causes the elements to
expand and contract which creates a
high-pressured wave (i.e., soundwave). A
series of soundwaves then propagate
toward tissue medium (e.g., mucus


membrane, bone). The transducer then
receives echoed soundwaves that are
reflected from the tissue medium and
transmits it to the system. The system
processes the echoed soundwaves into
an image which is displayed on the
display monitor screen of the system for
user interpretation.


Philips CX50 Diagnostic Ultrasound
System
K# Pending
(Subject Device)

Philips CX50 Diagnostic Ultrasound
Systems is intended for diagnostic
ultrasound imaging in B (or 2- D), M-
mode (including Anatomical M-mode),
Pulse Wave Doppler, Continuous Wave
Doppler, Color Doppler, Tissue Doppler
Imaging and Harmonics (Tissue and
Contrast) modes.
It is indicated for diagnostic ultrasound
imaging and fluid flow analysis in the
following applications: Ophthalmic
Intraoperative Laparoscopic Fetal
Abdominal Pediatric Small Organ Adult
Cephalic Neonatal Cephalic Trans-
vaginal Musculo-skeletal Gynecological
Cardiac Adult Cardiac Pediatric Trans-
Esoph. (Cardiac) Intracardiac echo
Peripheral Vessel Other (Carotid)

Duration of Use
Limited (≤ 24 hours)
Limited (≤ 24 hours)
Identical

Scientific
Ultrasound Imaging
Ultrasound Imaging
Identical

System console generates electrical
current and sends to a connected,
compatible transducer to stimulate its

Table 4: Technological Comparison of Subject Device (i.e., Philips CX50 Diagnostic Ultrasound System) & Predicate Device


piezoelectric elements at the distal end.
Stimulation causes the elements to
expand and contract which creates a
high-pressured wave (i.e., soundwave). A
series of soundwaves then propagate
toward tissue medium (e.g., mucus
membrane, bone). The transducer then
receives echoed soundwaves that are
reflected from the tissue medium and
transmits it to the system. The system
processes the echoed soundwaves into
an image which is displayed on the
display monitor screen of the system for
user interpretation.

Biocompatibility
ISO 10993-1
ISO 10993-1
Identical


Philips Sparq Diagnostic Ultrasound
System
K# Pending
(Subject Device)

Philips Sparq Diagnostic Ultrasound
System is intended for diagnostic
ultrasound imaging in B (or 2- D), M-
mode (including Anatomical M-mode),
Pulse Wave Doppler, Continuous Wave
Doppler, Color Doppler, Tissue Doppler
Imaging and Harmonics (Tissue and
Contrast) modes. It is indicated for
diagnostic ultrasound imaging and fluid
flow analysis in the following
applications: Ophthalmic Fetal
Abdominal Pediatric Small Organ Adult
Cephalic Trans-vaginal Trans-rectal
Musculo-skeletal Gynecological Cardiac
Adult Trans-Esoph. (Cardiac) Peripheral
Vessel

System console generates electrical
current and sends to a connected,
compatible transducer to stimulate its
piezoelectric elements at the distal end.
Stimulation causes the elements to

Table 5: Technological Comparison of Subject Device (i.e., Philips Sparq Diagnostic Ultrasound System) & Predicate Device


expand and contract which creates a
high-pressured wave (i.e., soundwave). A
series of soundwaves then propagate
toward tissue medium (e.g., mucus
membrane, bone). The transducer then
receives echoed soundwaves that are
reflected from the tissue medium and
transmits it to the system. The system
processes the echoed soundwaves into
an image which is displayed on the
display monitor screen of the system for
user interpretation.


QLAB Advanced Quantification
Software
K# Pending
(Subject Device)

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

Semiautomatic border detection,
chamber identification, contour
generation, measurement parameters

Table 6: Technological Comparison of Subject Device (i.e., QLAB Advanced Quantification Software) & Predicate Device


Subject Device
Hologic, Inc.
Genius AI Detection

Predicate Device
iCAD Inc.
PowerLook®
Tomo

21 CFR 892.2090 /
Radiological Computer Assisted
Detection and Diagnosis Software

A radiological computer assisted detection
and diagnostic software is an image
processing device intended to aid in the
detection, localization, and
characterization of fracture, lesions, or
other disease specific findings on acquired
medical images (e.g. radiography, MR, CT).
The device detects, identifies and
characterizes findings based on features
or information extracted from images, and
provides information about the presence,
location, and characteristics of the
findings to the user. The analysis is
intended to inform the primary diagnostic
and patient management decisions that
are made by the clinical user. The device
is not intended as a replacement for a
complete clinician's review or their
clinical judgment that takes into account
other relevant information from the
image or patient history.


Genius AI Detection is a computer-aided
detection and diagnosis (CADe/CADx)
software device intended to be used with
compatible digital breast tomosynthesis
(DBT) systems to identify and mark
regions of interest including soft tissue
densities (masses, architectural
distortions and asymmetries) and
calcifications in DBT exams from
compatible DBT systems and provide
confidence scores that offer assessment
for Certainty of Findings and a Case Score.
The device intends to aid in the
interpretation of digital breast
tomosynthesis exams in a concurrent
fashion, where the interpreting physician
confirms or dismisses the findings during
the reading of the exam.

PowerLook® Tomo
Detection V2 software
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

Hologic Selenia Dimensions
Hologic 3Dimensions
Supports both models in the following
modes:
• standard resolution 1-mm slices
• high resolution 1-mm slices
(Clarity HD),
• high resolution 6-mm SmartSlices
(3DQuorum)

cHaolcloifgicica tSieolnesn itah at may
bDeim ceonnsfiiromnse d(s otar ndard
dreissmoliustsieodn ,b 1y- tmhme
isnlitceersp) reting physician.
GE Pristina

The subject
device and
predicate device
are compatible
with different
systems as
noted.

Radiological computer assisted
detection and diagnostic software.


Concurrent read. FFDM
and 2D synthetic views
when available are to
be reviewed before


Predicate Device
Aidoc Briefcase for PE triage
(K190072)

Subject Device
Aidoc Briefcase for iPE triage
(K201020)

BriefCase is a radiological
computer aided triage and
notification software indicated for
use in the analysis of 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 Pulmonary
Embolism (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
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 contrast-
enhanced chest CTs (but not
dedicated CTPA protocol).
The device is intended to
assist hospital networks and
trained radiologists in workflow
triage by flagging and
communication of suspected
positive cases of incidental
Pulmonary Embolism (iPE)
pathologies. For the iPE
pathology, the software is only
intended to be used on single-
energy exams. The device is
intended to work with GE and
Siemens scanners only.
BriefCase uses an artificial
intelligence algorithm to analyze
images and flag suspect cases on
a standalone desktop application
in parallel to the ongoing
standard of care image
interpretation. The user is
presented with notifications for
suspect cases. 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.

Inclusion Criteria
- CTPA protocols.
- Single energy exams.
- Scans performed with 64-
slice scanner or greater
number of detectors.
- Scans performed on
adults/transitional adults ≥ 18
years of age.
- Slice thickness 0.5 - 3.0 mm
axial.
Exclusion Criteria
- All studies that are technically
inadequate, including studies
with motion artifacts, severe
metal artifacts, sub-optimal
bolus or inadequate field of
view.

Inclusion criteria
- Contrast-enhanced chest CTs
(but not dedicated CTPA
protocol.
- Single energy exams.
- Scans performed with a 64
slice or greater number of
detectors.
- Scans performed on
adults/transitional adults ≥ 18
years of age.
- Slice thickness: 0.5mm –
2.0mm axial.
Exclusion Criteria
- All studies that are technically
inadequate, including studies
with motion artifacts, severe
metal artifacts, or inadequate
field of view.

Contrast-enhanced chest CTs (but
not dedicated CTPA protocol)

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 low-quality,
compressed, grayscale preview
image that is captioned “Not for
diagnostic use”.

No. The device operates in
parallel with the standard of care,
which remains the default option
for all cases. Unflagged cases
are not de-prioritized.


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


Feature
Subject Device
Predicate Devices

Loading of a series of
appropriate CT from the patient
database

Acquisition Part
ECG-gated / ECG-triggered
ECG-gated / ECG-triggered

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.
Each calcification is labeled
according to one of four coronary
arteries it most probably belongs to.
In addition, results of the evaluation
can be sent via Rapid Results
Technology to any generic DICOM
viewer.
Comparison to the predicate
device:
The first part of the automatic
Calcium Scoring algorithm works in
the same manner as cleared with the
predicate device. From functional
perspective there are no differences.
The second part (labeling of
calcifications according to coronary
artery) is new in the subject device.

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.

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

Automatic definition of ROIs and
assignment of a generic calcium
label to the lesions

Calculation and display of the
2D-Agatston score/factor or
other metric on the defined ROIs

Interactive definition of ROIs (for
example noise) to disqualify the
region from participation in the
score


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

covering electrical and mechanical safety listed below, prior to introduction into interstate commerce:


Submitted by
Resonance Health Analysis S

US Contact (US Agent)
Michael van der Woude


892.1000 Magnetic Resonance Diagnostic Device


System, Nuclear Magnetic
Resonance Imaging, System, Image
Processing Radiological

Trade/Common Name
HepaFat-AI
HepaFat-Scan

Standalone software platform
designed to automatically analyse
within seconds magnetic resonance
imaging (MRI) datasets to generate
an estimate of the patient’s
volumetric liver fat fraction (VLFF),
converted into proton density fat
fraction (PDFF) and steatosis grade.
No user input is required for the
analysis thus minimising the impact
of human error on obtained results.

Standalone software application to
facilitate the import and visualization
of multi-slice, gradient-echo MRI
data sets encompassing the abdomen,
with functionality independent of the
MRI equipment, to provide objective
and reproducible determination of the
triglyceride fat fraction in magnetic
resonance images of the liver. It
utilises magnetic resonance images
that exploit the difference in
resonance frequencies between
hydrogen nuclei in water and
triglyceride fat. The quantitative
triglyceride fat fraction is based on
the measurement of a magnetic
resonance parameter that reflects the
ratio of the proton density signal of
triglyceride fat to the total proton
density signal in the liver.

The table below summarizes the main similarities and differences between HepaFat-AI and the predicate.


Convolutional neural networks for
the image analysis.
Algorithmic for the images quality
checking and Alpha conversion into
VLFF.

Algorithmic, with human interaction
for Region of Interest (ROI)
selection.

1. Supporting clinical diagnoses
about the status of liver fat content.
2. Supporting the subsequent
clinical decision-making processes.
3. Supporting the use in clinical
research trials, directed at studying
changes in liver fat as a result of
interventions.
4. It contains an image viewer for
importing DICOM images, browsing
through patient datasets, viewing
images and performing region of
interest analysis.

HepaFat-AI is intended for
quantitative measurement of the
triglyceride fat fraction in magnetic
resonance images of the liver, also
known as volumetric liver fat
fraction (VLFF).
It utilises magnetic resonance images
that exploit the difference in
resonance frequencies between
hydrogen nuclei in water and
triglyceride fat. The quantitative
triglyceride fat fraction is based on
the measurement of a magnetic
resonance parameter that reflects the
ratio of the proton density signal of
triglyceride fat to the total proton
density signal in the liver.
When interpreted by a trained
physician, the results provide
information that can aid in
diagnosis.

HepaFat-Scan is a software device
intended for quantitative
measurement of the triglyceride fat
fraction in magnetic resonance
images of the liver. It utilises
magnetic resonance images that
exploit the difference in resonance
frequencies between hydrogen nuclei
in water and triglyceride fat. The
quantitative triglyceride fat fraction is
based on the measurement of a
magnetic resonance parameter that
reflects the ratio of the proton density
signal of triglyceride fat to the total
proton density signal in the liver.
When interpreted by a trained
physician, the results provide
information that can aid in diagnosis.

HepaFat-AI is indicated to:
Assess the volumetric liver fat
fraction, proton density fat
fraction and steatosis grade
in individuals with
confirmed or suspected fatty
liver disease;


When interpreted by a trained
physician, the results can be used to
• Monitor liver fat content in
patients undergoing weight
loss management and can be
used to
• Aid in the assessment and
screening of living donors
for liver transplant

in water and triglyceride fat. The
quantitative triglyceride fat fraction is
based on the measurement of a
magnetic resonance parameter that
reflects the ratio of the proton density
signal of triglyceride fat to the total
proton density signal in the liver.
When interpreted by a trained
physician, the results provide
information that can aid in diagnosis.

User
Radiologist
Resonance Health’s trained analyst

Hosting platform
Cloud-based or onsite platform
Resonance Health’s internal server

Image-type utilized
Magnetic Resonance
Magnetic Resonance

• Unique Report ID
• Patient ID, patient name and date
of birth for full identification of
the patient.
• Scan date, and analysis date.
• Referrer and MRI centre.
• Results displayed: VLFF (%),
PDFF (%) and Steatosis grade,
associated with confidence
intervals and normal range.
• Pictures of the 3 TEs of the
analysed slice.
• Liver colour map (for illustration
purpose only, not for diagnostic)

• Unique Report ID
• Patient ID, patient name and date
of birth for full identification of
the patient.
• Scan date, and analysis date.
• Referrer and MRI centre.
• Results displayed: VLFF (%)
associated with confidence
intervals and normal range.
• Picture of the analysed slice.


biopsy at the three previously determined VLFF thresholds.


Xeleris 4.0 Processing and Review Workstation


510(k) Premarket Notification Submission


Attribute
Predicate Device: Xeleris 4.0
Proposed Device: Xeleris V

Xeleris 4.0’s workflows use
both manual and automated
processes.

Xeleris V’s workflows continue
use both manual and automated
processes. Xeleris V also includes
two new, DL-based automatic
segmentation algorithms.

Xeleris 4.0 does not contain
any DL processes/algorithms.

Xeleris V introduces two new DL-
based algorithms for:
• Lung fissure segmentation as
an alternative to the manual
method.
• Kidney segmentation as an
enhancement to the non-DL
automatic segmentation.

Hardware
Needed to
Support
Xeleris V’s
software

Xeleris 4.0 offered with a GE
workstation or as software
that can be loaded onto the
customer’s workstation that
meets specification.

In addition to the two options for
the predicate, with Xeleris V the
software can also be installed on a
remote server.


MI General (MI Reading / Auto Lung 3D
SPECT Processing) Dynamic Summing
Automatic Layouts
Auto Ranges
Scanner Data Support for Organ Processing
Usability Improvements

MI Cardiology Normalization by Rate-Pressure Product (syngo MBF)
Cardiac Masking
Cardiac Auto Ranges
Usability Improvements
Updates / redeployment to third party software

MI Neurology
Normals Database for FDOPA (Scenium)

software (K191309 and K110494) include the following new features:


892.2050 – Picture Archiving
and Communication System

Limbus Contour is a software-
only medical device intended
for use by trained radiation
oncologists, dosimetrists and
physicists to derive optimal
contours for input to radiation
treatment planning.
Supported image modalities
are Computed Tomography
and Magnetic Resonance. The
Limbus Contour Software
assists in the following
scenarios:
• Operates in conjunction with
radiation treatment planning
systems or DICOM viewing
systems to load, save, and
display medical images and
contours for treatment
evaluation and treatment
planning.

Microsoft Radiomics App v1.0
is a software-only medical
device intended for use by
trained radiation oncologists,
dosimetrists and physicists to
derive optimal organ and
tumor contours for input to
radiation treatment planning.
Supported image modalities
are Computed Tomography
and Magnetic Resonance.
Radiomics App assists in the
following
scenarios:
• Load, save and display of
medical images and contours
for treatment evaluation and
treatment planning.
• Creation, transformation, and
modification of contours for

Indications for
use are similar
other than the
device not
displaying
medical
images and
contours.
Related to that
difference; the
device is also
not capable of
fusing
compatible
images for
treatment
planning or
three-
dimensional
rendering of
medical

automatic contouring test to ensure the contours were accurate.


• Creation, transformation, and
modification of contours for
applications including, but not
limited to: transferring
contours to radiotherapy
treatment planning systems,
aiding adaptive therapy and
archiving contours for patient
follow-up.
• Localization and definition
of healthy anatomical
structures.
Limbus Contour is not
intended for use with digital
mammography.
Limbus Contour is not
intended to automatically
contour tumors or tumor
clinical target volumes.

applications including, but not
limited to: transferring
contours to radiotherapy
treatment planning systems,
aiding adaptive therapy, and
archiving contours for patient
followup.
• Localization and definition of
both solid tumors and healthy
anatomical structures.
• Fusion display of compatible
images for treatment planning.
• Three-dimensional rendering
of medical images and the
segmented contours.
Images reviewed using the
Radiomics App software
should not be used for primary
image interpretations.
Radiomics App is not for use
with digital mammography.

images and
segmented
contour.
Unlike the
predicate
device, the
Limbus
Contour does
not display
images, and
therefore it
cannot be used
for “primary
image
interpretations”
so that is not
included in the
Limbus
Contour
indications.
In addition, the
device only
localizes and
defines healthy
anatomical
structures (not
solid tumors
like the
predicate
device).

Intended User
Healthcare providers
Healthcare providers
Same

Contours
generated from
Limbus
Contour are
edited in
external
treatment-
planning or
contouring
tools.

2D distance measurement,
average tissue density within a
region (for CT), segmentation
volume

Limbus
Contour does
not contain an
image viewer.
No
measurement
functionality is
provided
because of this.
These

Limbus AI Limbus Contour 510(k) Submission


measurements
are not
necessary to
achieve
intended use.

Limbus
Contour does
not perform
image fusion
and subsequent
contouring on
fused images.
Not necessary
to achieve
intended use.

Limbus
Contour does
not contain a
viewer. Images
are rendered in
a separate
viewing tool.

Image Modalities
CT and MR
CT and MR
Same

Stand-alone package which
operates on Microsoft
Windows operating system
and MacOS operating system

Stand-alone package which
operates on Microsoft
Windows operating system
only.

Limbus
Contour will
also support
Mac OS
operating
systems

Materials
N/A – Standalone Software
N/A – Standalone Software
Same

Energy Source
N/A – Standalone Software
N/A – Standalone Software
Same

Feature
Comparison:
(cid:120) Operating
System
(cid:120) Hardware
Requirements
(cid:120) Etc.

Operating System
(cid:120) Windows 10 / Windows
Server 2016
(cid:120) Mac OS 10.14
Hardware Requirements
(cid:120) 2 GHz or faster multi-core
processor
(cid:120) 4 GB of RAM
(cid:120) For GPU versions, a
CUDA capable NVIDIA
GPU is required

Two different types of
verification testing were
conducted to verify the
software requirements:

Rendering and
measurement
tests are not
applicable for
the subject


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 preclude clinical
assessment of CT cases.

Adult patients (21 years of age and
older) indicated for head CT

Notification-only, parallel workflow
tool

Hospital networks and trained
clinicians

Identify patients with a pre-
specified clinical condition

Cerebrovascular Event:
Intracranial hemorrhage

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

Independent of standard of care
workflow

Modality
Non-Contrast head CT
Non-Contrast head CT

Artificial Intelligence algorithm
Yes
Yes

Software segmentation method
CNN-based segmentation
Machine-vision based segmentation

Case level assessment of clinical
condition probability

Yes – case-level assessment is
derived both from detection of
individual aICH findings and
algorithmic assessment of the full
case.

Yes – case-level assessment is
derived from detection of individual
aICH findings

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


Limited to analysis of imaging data
Yes
Yes

Aids prompt identification and
prioritization of cases with
indicated findings

Medical systems/devices used in
conjunction with the device

1. Device is used with CT systems
for DICOM input and with PACS
systems, which may present/use
the data.
2. Device is used with Medical
Image Communications Devices
(MICDs), such as the Accipio
Agent, to receive native CT
images for processing and to
generate visual results

Suspected hemorrhage /
No suspected hemorrhage


Classification Name
: System, Image Proc


Manufacturer
See-Mode Technologies Pte. Ltd.
Atheropoint LLC

510(k) number
Via this submission
K122022

Analysis and reporting of vascular
ultrasound images

See-Mode AVA (Augmented Vascular
Analysis) is a stand-alone, image
processing software for analysis,
measurement, and reporting of
DICOM-compliant vascular ultrasound
images obtained from carotid and lower

The AtheroEdgeTM
software is a
Windows-based application
program used on a personal
computer for an automatic
measurement of the


limb arteries. The analysis includes
segmentation of vessels walls and
measurement of the intima-media
thickness (IMT) of the carotid artery in
B-Mode images, finding velocities in
Doppler images, and reading annotations
on the images. The software generates a
vascular ultrasound report based on the
image analysis results to be reviewed and
approved by a qualified clinician after
performing quality control. The client
software is designed to run on a standard
desktop or laptop computer.
See-Mode AVA is intended to be used by
trained medical professionals, including
but not limited to physicians and medical
technicians. The software is not intended
to be used as an independent source of
medical advice, or to determine or
recommend a course of action or
treatment for patients.

Intima-Media Thickness
(IMT) of the carotid artery
from images obtained from
ultrasound systems.

Image Source
Ultrasound images
Ultrasound images
Same

The software runs on a standard
“off-the-shelf” computer and can be
accessed within the software client web
browser.

Stand-alone application
program for use on a
personal computer with
Microsoft Windows.

Automatic
distance
measurement of
the Intima- Media
thickness of
carotid artery


As the device is prescription only, the
target population of the device is anyone
in the general population that receives
the relevant carotid or lower limb artery
ultrasound scan

As the device is prescription
only, the target population of
the device is anyone in the
general population that
receives the relevant carotid
ultrasound scan


Classification Name
Automated Radiological Image

Classification Name
System, Image Processing, Rad


Description and Comparison of the Subject Device to the Predicate Device

Routine Contouring tools (e. g. freehand drawing tools, creation of margins
etc.)
Modification:improvements in the contour interpolation tool and a tool to
merge multiple structures.

Advanced Contouring tools (automatic contouring of different structures,
nudge 3D tool,contour interpolation.). Automatic contouring of pelvic and
head/neck regions, support of Rapid Results Technology.
Modification: This subject device provides the following extensions:
• Automatic Contouring can be applied on further structures (thoracic and
pelvic regions)
• Automatic Contouring in the head/neck region, which was previously atlas-
based, is now done with deep learning. The atlas method is entirely removed
from this version.
• Streamlined workflow to automatically adapt contours from a prior to a
current planning CT

provided as Table 4 below for the software version SOMARIS/8 VB50:


• Loading and storing of DICOM RT structure sets, creating, editing and
deletion of structures and POIs.
• Creating, editing and deletion of structure templates.
• Customize predefined structure database with mapping to international
nomenclature schemes.
Modification:
• multiselection of structures and POIs to apply basic operations such as copy
or delete,
• auto-completion for structure names,
• manual and automatic save function for structure sets,
• and modifications in the user interface of structure database and template
creation.

Deformable registration of images of the same patient acquired with the same
or different modalities within different imaging sessions. The transformation
allows for local deformation to adapt to changing anatomy (many degrees of
freedom).
Modification: The deformation visualization tool was simplified and now
utilizes color-coded vectors to display the deformation vector field and its
magnitude at the same time. The visualization is restricted to the patient outline
for CT images.

Traditional 510(k): syngo.via RT Image Suite


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


Classification Name
Medical image analyzer


CLEARREAD DETECT is
a computer-aided detection
(CAD) system intended to
identify and mark regions
of interest (ROIs) on
digitized frontal chest
radiographs. It identifies
features associated with
solitary pulmonary nodules
from 9 to 30 mm in size,
which could represent
early-stage lung cancer.
The device is intended for
use as an aid only after the
physician has performed
an initial interpretation of
the radiograph.

The Auto Lung Nodule
Detection is computer-
aided detection software to
identify and mark regions
in relation to suspected
pulmonary nodules from 10
to 30 mm in size. It is
designed to aid the
physician to review the PA
chest radiographs of adults
as a second reader and be
used as part of S-Station,
which is operation software
installed on Samsung
Digital X-ray Imaging
systems. Auto Lung Nodule
Detection cannot be used
on the patients who have
lung lesions other than
abnormal nodules.

heuristic decision rules,
artificial neural network, and
fuzzy logic

Operating systems
Standard PC/Windows
Standard PC/Windows

ROI marked on the
duplicated input image

Information for ROI to be
marked on the duplicated
input image

Reader workflow
Second reader workflow
Second reader workflow

510(k) Premarket Notification - Traditional


GE Medical Systems, LLC (GE Healthcare)
3200 N. Grandview Blvd.,
Waukesha, WI 53188
USA

Brian R. Zielski
Regulatory Affairs Leader
Phone: 262-521-6609
Email: Brian.Zielski@GE.com

James McMahon
Senior Director, Regulatory Affairs
Phone: 508-382-2858
Email: James.D.McMahon@GE.com

Common/Usual Name:
Magnetic Resonance Diagnostic Device

Classification Names:
Regulation Number:

Magnetic Resonance Diagnostic Device
21 CFR 892.1000

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


Predicate Device(s):
SIGNA Premier (K193282)

SIGNA 7.0T is a high performance magnetic resonance
imaging system designed to support high resolution
imaging at 7.0T in particular anatomical regions
determined by the available RF coils. The system includes
a 7.0T superconducting magnet and an ultra-high
performance gradient coil with a 60 cm patient bore,
supporting scanning in axial, coronal, sagittal, oblique,
and double oblique planes using a variety of pulse
sequences, imaging techniques, acceleration methods,
and reconstruction algorithms.

The SIGNA 7.0T system is a whole-body magnetic resonance
scanner designed to support high resolution, high signal-to-
noise ratio, and short scan times. It is indicated for use as a
diagnostic imaging device to produce axial, sagittal, coronal,
and oblique images, spectroscopic images, parametric maps,
and/or spectra, dynamic images of the structures and/or
functions of the head and extremities.
The images produced by the SIGNA 7.0T system reflects the
spatial distribution or molecular environment of nuclei
exhibiting magnetic resonance. These images and/or spectra
when interpreted by a trained physician yield information that
may assist in diagnosis.
The device is intended for patients > 20 kg / 44 lb.

The changes in technology do not impact the indications
for use. The indications for use have not changed, other
than to reflect the SIGNA 7.0T product name and
simplified anatomy of head and extremities, and patient
weight limit.


Therefore, the intended use is the same as the predicate
device in accordance with FDA’s guidance document “The
510(k) Program: Evaluating Substantial Equivalence in
Premarket Notifications [510(k)]”, dated 28 July 2014.

The SIGNA 7.0T employs the same fundamental scientific
technology as the predicate device.
System Design:
The most notable technological difference between the
SIGNA 7.0T and the predicate device is the 7.0T B0
magnetic field compared to 3.0T. The SIGNA 7.0T design
enables the capabilities that this higher B0 magnetic field
contributes to MR imaging through the following key
differences:
• RF Transmit chain: The SIGNA 7.0T employs
multiple and independent channels for RF
transmission, and dedicated receiver array coils
and detectors for high sensitivity signal reception.
• Gradient system: The SIGNA 7.0T can deliver a
maximum gradient amplitude of 113 mT/m and
maximum gradient slew rate of 260 T/m/s
compared to the predicate’s maximum gradient
amplitude of 80 mT/m and maximum gradient
slew rate of 200 T/m/s.
• Applications: The SIGNA 7.0T uses the SIGNA
Works suite of applications, optimized for the
advanced hardware and for the higher field
strength to generate high resolution functional,
structural, anatomical, vascular, and
spectroscopic images.
Operating Principles: The SIGNA 7.0T functions using the
same operating principles as the predicate device.
Materials: The SIGNA 7.0T and the predicate device both
use flame retardant materials.
Safety and Performance Testing: Both the SIGNA 7.0T
and the predicate device comply with the same safety
and performance testing (see Determination of
Substantial Equivalence, below).


These technological differences do not raise any different
questions regarding safety and effectiveness. Both
devices must address questions of whether they provide
an adequate level of image quality appropriate for
diagnostic use. The performance data described in this
submission include results of both bench testing and
clinical testing that show the image quality performance
of SIGNA 7.0T compared to the predicate device.

Determination of Substantial
Equivalence:

Summary of Non-Clinical Tests:
The SIGNA 7.0T and the predicate device were subject to
similar risk management testing to demonstrate substantial
equivalence of safety and performance. Testing to the
following voluntary standards includes:
• ANSI/AAMI ES60601-1
• AAMI/ANSI/IEC 60601-1-2
• IEC 60601-2-33
• AAMI/ANSI/IEC 62304
• AAMI/ANSI/ISO 10993-1
In addition, the SIGNA 7.0T complies with applicable NEMA MS
standards for MRI and NEMA PS3 standards for DICOM, as
does the predicate device.
The following quality assurance measures were applied to the
development of the subject device, as they were for the
predicate device:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Simulated use testing (Validation)


Summary of Clinical Tests:
To evaluate the image quality performance of the SIGNA 7.0T
system, assessments were performed by GE MR internal
Clinical Applications Specialists and external Radiologist as part
of a Reader Evaluation Study.
The reader study was performed on images acquired on the
proposed 7.0T system and predicate 3.0T system. Image
series ranged from brain MR scans performed on normal
subjects and subjects with self-reported common
neuropathology, as well as knee images over a broad age
range representative of a range of knee health.
The study involved 4 U.S. board-certified radiologists
evaluating proposed device’s image diagnostic quality and
usability, personal preferences, and general commentary using
radiology terms against same subject images scanned on the
predicate device.
To set the PNS limits for the SIGNA 7.0T system, a direct
determination study was conducted with adult human
volunteers without reported pathology.

The proposed SIGNA 7.0T was developed under GE
Healthcare’s quality system and is at least as safe and effective
as the legally marketed predicate device. The performance
testing did not identify any new hazards, adverse effects, or
safety or performance concerns that are significantly different
from those associated with MR imaging in general.
In conclusion, GE Healthcare believes that SIGNA 7.0T is
substantially equivalent to the predicate device, and is safe
and effective for its intended use.


TomTec-Arena software is a clinical
software package designed for
review, quantification and reporting of
structures and function based on
multi-dimensional digital medical data
acquired with different modalities.
TomTec-Arena is not intended to be
used for reading of mammography
images.

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

TOMTEC-ARENA software is a
clinical software package designed
for review, quantification and
reporting of structures and function
based on multi-dimensional digital
medical data acquired with different
modalities.TOMTEC-ARENA is not
intended to be used for reading of
mammography images.

Intended Use of primary and subject
device are identical
(unchanged)Intended Use/Indications
for use of secondary predicate and
subject device are comparable and
considered equivalent.

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

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

Indications for use of primary and
subject device are identical
(unchanged).
Intended Use/Indications for use of
secondary predicate and subject
device are comparable and
considered equivalent.

Quantification and reporting of
cardiovascular, fetal, and abdominal
structures and function.

Quantification of imaging data
acquired from ultrasound machines of
various anatomical structures and
function.

Identical to primary and secondary
predicate.

where used
(hospital, home,
ambulance, etc.)

Hospitals, clinics, and physician´s
offices.

4D RV-Function provides a
comprehensive evaluation of the right
ventricle including volumes and strain
analysis. It provides EDV, ESV,
RVEF, SV, RVLS, TAPSE and FAC.
Distance measurements can also be
analyzed. This software
delivers a quick and reproducible
analysis of the right ventricle, thus

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.

The 4D RV-Function is a right
ventricular quantification tool for
routine clinical work, pulmonary
hypertension, and right-sided heart
failure. The application helps to
overcome complexity of right-
ventricle analysis by calculating
standard values based on a semi-

Revised for clarity. Considered
equivalent to primary predicate. No
impact to the safety or effectiveness
of the device.
Comparable and considered
equivalent to secondary predicate.
This modification to QLAB was
cleared by K191647.


increasing your diagnostic confidence
by visualizing the complexity of the
RV shape in 3D.

automatically generated 3D surface
model.

Updated due to changes to SW code.
Integrates HeartModel auto-
segmentation technology with 4D RV-
Function algorithm for RV border
placement.

Added measurements are identical to
secondary predicate device.

Added:
Beutel value export into .stl and .obj
format

Identical to secondary predicate.
Workflow improvements for user
convenience.
No impact to the safety or
effectiveness of the device.

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
automatically using machine learning
algorithms without user interaction.
User is able to edit, accept or reject
the contours or the anatomical
landmarks.

4D MV-Assessment is used for
comprehensive morphological and
functional assessment of the mitral
valve. Based on an easy and intuitive
workflow the application package
generates models of anatomical
structures such as MV annulus,
leaflet and the closure line.
Automatically derived parameters
allow quantification of pre- and post-
operative valvular function and
comparison of morphology. 4D MV-
Assessment improves the
presentation of anatomy and findings
and visualizes the complex
morphology and dynamics of the
mitral valve.

The 3D Auto MV Q-App is a semi-
automatic tool that essentially is an
integration of the machine-learning
derived segmentation engine of the
QLAB HeartModel and the TOMTEC-
Arena TTA2 4D MV-Assessment
application thereby providing a
dynamic Mitral Valve clinical
quantification tool.

4D MV-ASSESSMENT provides a
morphological and functional analysis
of the mitral valve (MV) using 3D/4D
echocardiography data. Models of
anatomical structures such as MV
annulus, leaflets and the closure line
are generated. The derived
parameters allow quantification of
pre- and post-operative valvular
function and a comparison of
morphology.

Revised for clarity. Considered
equivalent to primary predicate. No
impact to the safety or effectiveness
of the device.
Comparable and considered
equivalent to secondary predicate.
This modification to QLAB was
cleared by K200974-


Added:
Prolapse Height
Open Coaptation Gap
Open Coaptation Width
Open Coaptation Area 3D
C-shaped Annulus
Distal Anterior Leaflet Angle

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

3D surface model is created semi-
automatically using machine learning
algorithm without user interaction.
User is able to edit, accept, or reject
the initial landmark proposals of the
mitral valve anatomical locations.

Identical to secondary predicate.
Workflow improvements for user
convenience in initial model display
and landmark proposal.
User is still able to edit, accept or
reject the contours.
No impact to the safety or
effectiveness of the device.

Volume quantification and function
analysis of the left ventricle based on
3D data has proven to be more
accurate and reproducible than using
2D clips. 4D LV-Analysis is a vendor
independent offline solution for 3D
speckle tracking. It provides an
automated workflow for quantitative
and reproducible analysis of left
ventricular deformation and global
strain values. 4D LV Function is a
basic application for the assessment
of left ventricular volumes, EF and
GLS while 4D LV Analysis allows for
advanced investigations including
twist, regional strain and deformation
analysis. Results are mapped onto
the LV Beutel surface for clear
visualization. All results can be stored
and exported.

The Dynamic HeartModel (DHM)
provides automatic 3D anatomical
borders and left ventricle (LV) and left
atrium (LA) border tracking across all
frames of the cardiac cycle or cycles.

4D LV-ANALYSIS provides
morphological and functional
analyses of the left ventricle. Based
on 3D echo datasets a 4D model
(Beutel) is generated that represents
the cavity of the LV and optionally
also the LA. Volumes, Strain and
Displacement are quantified on a
global and segmental level.

Revised for clarity. Considered
equivalent to primary predicate. No
impact to the safety or effectiveness
of the device.
Comparable and considered
equivalent to secondary predicate.


Added:
LA EDV (LA EDVI)
LA ESV (LA ESVI)
LA PreAV (LA PreAVI)
LA trueEF
LA EF
LA GLS

Same technology extended to Atrium
(LA Option in 4D LV-Analysis).
LA EDV corresponds to LAVmin, and
LA ESV corresponds to LAVmax.
LA PreAV is based on the same
dynamic quantification as LA volume
curve (prior to contraction).
LA trueEF uses the same formula as
LA EF but different volume values
(LA PreAV instead of LAVmax).
LA GLS is a well-known parameter
and described in clinical literature.

Added:
Beutel value export into .stl and .obj
format

Identical to secondary predicate (see
"4D RV-Function").

Adapted Bullseye based an ASE2015
guideline.
Workflow improvements by removed
Beutel revision step & contour
proposal and retracking within
tracking revision step.

Workflow improvements for user
convenience. No impact to the safety
or effectiveness of the device.

n/a - features and functionality were
part of IMAGE-COM (AutoSTRAIN
Addins) and 2D CPA

AutoStrain is a quantification tool of
global and regional function based on
contour detection and tracking. It
supports a bull’s eye display of Time
to Peak Longitudinal Strain and End-
Systolic Longitudinal Strain. Further,
this CAP provides the calculation of
GLS (Global Peak Longitudinal
Strain).

Based on cleared Addins of IMAGE-
COM and 2D CPA, a dedicated
module (CAP) was released.
This CAP only includes features and
measurements that were already
available in IMAGE-COM (and
respective Addins), 2D CPA or have
been cleared by QLAB. The
integration "on cart" requires
dedicated CAPs (e.g. for the
application layout). This CAP is used
in the same clinical context and
workflows. No impact to the safety or
effectiveness of the device.

No previous SW version as features
and functionality were included in
IMAGE-COM and/or 2D CPA


Image-Com is a dedicated DICOM viewer for
cardiovascular ultrasound and Cath Lab
examinations. Easy and quick
image review is supported by a variety of time
saving features. Prior studies can easily be
compared with current
examinations and the simultaneous display of Cath
Lab, echo or nuclear medicine examinations
provides additional
clinical information.

IMAGE-COM is a basic module for reviewing and
measuring digital medical data. It supports routine
workflows for loading, analyzing and saving
medical studies, e.g. for the purpose of creating
reports. IMAGE-COM is where basic
measurements can be performed and the entry
point for advanced analysis modules. Study related
routine measurements can be imported, displayed,
edited and exported to accompanying reporting
systems.

Revised for clarity. Considered equivalent to
primary predicate. No impact to the safety or
effectiveness of the device.

Added:
Annulus dmin
Annulus dmax
Annulus dmean
Annulus Area
Annulus Perimeter
Annulus d(area)
Ann-Ost left diam
Ann-Ost right diam
MV E Valsalva
MV A Valsalva
MV E/A Valsalva

Existing ECHO measurements have been
extended. No impact to the safety or effectiveness
of the device.

Existing Vascular measurements have been
extended. No impact to the safety or effectiveness
of the device.


ECHO and Vascular were extended to Pediatric.
Extension of existing measurement methods to
Cath.

IMAGE-COM is available as a zero footprint
solution (TOMTEC ZERO). No change in intended
use or use environment. No impact to the safety or
effectiveness of the device.

AutoLV enables IMAGE-COM to quantify left
ventricular function based on 4-chamber and 2-
chamber views of the left ventricle (biplane
Simpson) with a single mouse click per view

The AutoStrain application yields cardiac function
analysis based on a workflow. After selecting views
to analyze, and starting the application results are
shown directly for user’s review.

Added:
LVLd (A4C)
LVLs (A4C)
LVLd (A2C)
LVLs (A2C)
AVC

Length measurements/values added because of
user needs:
User is able to double check if LV axis is acquired
without foreshortening. In this case both Diastolic
and Systolic Major Axis should be similar.

Adapted Bullseye based on ASE2015 guideline.

AutoLA* is a fast and intuitive automation of
Simpson’s biplane method.
By selecting apical 4- and 2-chamber views,
AutoLA finds end-systole and proposes tracings of
the left atrial blood tissue interface

Extension of existing left atrium LA volume
(Simpson) measurements with contour proposal
step

Improvement for user convenience. No impact to
the safety or effectiveness of the device.

Cath QCA is a calculation of stenosis diameter and
area, obstruction and reference diameters and
obstruction length

Cath-QVLA is a calculation of EDV and ESV, EF,
SV, CO of the Left ventricle

4D Cardio-View is a vendor independent offline
solution to review and analyze 3D echo data. It
offers an easy and fast navigation to get the perfect
3D view with just two clicks by using the unique

4D CARDIO-VIEW is an advanced analysis tool for
3D/4D echocardiography data. Anatomical
structure visualization, volume measurements (LV
and/or generic), and specified or manual

Revised for clarity. Considered equivalent to
primary predicate. No impact to the safety or
effectiveness of the device.


D’Art tool. Features like the multi-slice D’Art
(multiple 2D slices), basic measurements and
workflow based volume measurements make 4D
Cardio-View an all-purpose solution for any cardiac
structure. All measurements and views can be
stored as bookmarks for easy retrieval at any time.

measurements are possible. Various tools are
available for rendering that display 2- and 3-
dimensional morphology and function for defined
structures.

Measurements
as cleared
Unchanged
Identical to primary predicate.

Added:
Beutel value export into .stl and .obj format

Identical to secondary predicate (see "4D RV-
Function").

2D CARDIAC-PERFORMANCE ANALYSIS (Adult and Fetal)

2D Cardiac Performance Analysis is a vendor
independent offline solution for the
quantification of left ventricular deformation.
Detailed analysis of myocardial velocity,
displacement, strain and strain rate is
performed based on 2D speckle tracking in
long or short axis views. Basic parameter
assessment and comprehensive result export
options make 2D CPA suitable for research
and routine use.

2D CARDIAC PERFORMANCE ANALYSIS
(2D CPA) provides parameters for myocardial
function and deformation analysis. Based on
two dimensional echo B-Mode datasets a
speckle tracking algorithm supports the
calculation of 2D-contour models of the
endocardial and epicardial border.
Corresponding velocities, displacements,
strains, strain rates and functional parameters
can be derived. The results are displayed as
figures, in charts or they are available as
numerical values.

FETAL 2D CARDIAC PERFORMANCE
ANALYSIS (FETAL 2D CPA) is a vendor
independent, offline solution for the
quantification of cardiac deformation of the
fetal heart. Detailed analysis of myocardial
velocity, displacement, strain and strain rate is
performed based on 2D speckle tracking in
the long axis views of the left ventricle and
right ventricle. Basic parameter assessment
as well as advanced quantifications, together
with comprehensive result export options,
make FETAL 2D CPA suitable for research
and routine use.

Analysis of the fetal heart can be performed
based on the cleared implementation of
speckle tracking that is available in 2D CPA.
Quantification of fetal structures is part of the
cleared Indications for Use. Technology
already available is applied within the
Intended Use/Indications for Use of the
device. Substantial evidence for this
modification is available.
Optimized workflow (exclusively for 4CH clips)
to analyze both ventricles in the same 4CH
clip and within the same application session.
Same algorithm for contour detection is used.


Extended to right ventricle strain and atrium
strain (e.g. GLS and segmental strain/strain
rate values).
- MAPSE (lateral and septal)
- Basal ventricle diameter at ES and ED of RV
and LV
- Ventricle length at ES and ED of RV and LV
- Myocardial area at ED of LV and RV

Existing measurements were extended to
right ventricle strain and atrium strain (similar
to LA Option).

Dedicated module for Ultrasound Reporting.

REPORTING provides various workspaces which
are dedicated to different clinical applications and
supports the workflow within clinical institutions.
Measurements can be imported, modified and
exported in order to support connected reporting
systems.

SW version is identical and correspond to the
TOMTEC-ARENA version, due to release
dependencies.

Added:
Vascular
Stress Echo
Pediatric
Fetal
TEE Pre/Post OP

Based on existing and extended measurements,
new workspaces were added in order to display
and structure those measurements in a dedicated
workspace (view) for easy clinical reporting. No
impact to the safety or effectiveness of the device.


Characteristic
Subject Device
Primary Predicate
Reference Device
Reference Device

Device Name
AVIEW LCS
AVIEW LCS
AVIEW LCS
Lung Nodule
AVIEW

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


Product Code
LLZ, JAK
LLZ, JAK
LLZ, JAK
LLZ, JAK

Review Panel
Radiology
Radiology
Radiology
Radiology

AVIEW LCS is intended for the review and analysis and reporting of thoracic CT images for the
purpose of characterizing nodules in the lung in a single study, or over the time course of several
thoracic studies. Characterizations include nodule type, location of the nodule and measurements
such as size (major axis, minor axis), estimated effective diameter from the volume of the nodule,
the volume of the nodule, Mean HU (the average value of the CT pixel inside the nodule in HU),
Minimum HU, Max HU, mass (mass calculated from the CT pixel value), and volumetric
measures (Solid Major; length of the longest diameter measured in 3D for a solid portion of the
nodule. Solid 2nd Major: The length of the longest diameter of the solid part, measured in sections
perpendicular to the Major axis of the solid portion of the nodule), VDT (Volume doubling time),
Lung-RADS (classification proposed to aid with findings) and CAC score and LAA analysis. The
system automatically performs the measurement, allowing lung nodules and measurements to be
displayed and, also integrate with FDA certified Mevis CAD (Computer-aided detection)
(K043617).

AVIEW LCS is intended for the review and analysis and reporting of thoracic CT images for the
purpose of characterizing nodules in the lung in a single study, or over the time course of several
thoracic studies. Characterizations include nodule type, location of the nodule and measurements
such as size (major axis, minor axis), estimated effective diameter from the volume of the nodule,
the volume of the nodule, Mean HU (the average value of the CT pixel inside the nodule in HU),
Minimum HU, Max HU, mass (mass calculated from the CT pixel value), and volumetric
measures (Solid Major; length of the longest diameter measured in 3D for a solid portion of the
nodule. Solid 2 Major: The length of the longest diameter of the solid part, measured in sections
nd
perpendicular to the Major axis of the solid portion of the nodule), VDT (Volume doubling time),
and Lung-RADS (classification proposed to aid with findings). The system automatically
performs the measurement, allowing lung nodules and measurements to be displayed and, also
integrate with FDA certified Mevis CAD (Computer-aided detection) (K043617).

Lung Nodule Assessment and Comparison Option (LNA)

The Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-
imaging tool. It is intended for the review and analysis of thoracic CT images, providing
quantitative and characterizing information about nodules in the lung in a single study, or over
the time course of several thoracic studies. Characterizations include diameter, volume and
volume over time. The system automatically performs the measurements, allowing lung nodules
and measurements to be displayed.

AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This
software could be used to support the physician quantitatively in the diagnosis, follow up
evaluation and documentation of CT lung tissue images by providing image segmentation of sub-
structures in lung, lobe, airways and cardiac, registration of inspiration and expiration which could
analyze quantitative information such as air trapping volume, air trapped index, and
inspiration/expiration ratio. And also, volumetric and structure analysis, density evaluation and
reporting tools. AVIEW is also used to store, transfer, inquire and display CT data set on premise
and as cloud environment as well to allow users to connect by various environment such as mobile
devices and chrome browser. Characterizing nodules in the lung in a single study, or over the time


Device Name:
Deep Learning Image Reconstruction

510(k) Number:
K183202 cleared on April 12, 2019

21 CFR 892.1750 Computed tomography x-ray system / JAK


Deep Learning Image
Reconstruction
(Predicate Device, K183202)

Compatible with single energy scan
modes and standard kernel.

Compatible with dual energy
scan modes and standard kernel.

Low contrast detectability (LCD),
image noise, contrast to noise ratio
(CNR), and high contrast spatial
resolution are as good or better
than ASiR-V when substituted using
raw data from the same scan.

Utilizes a dedicated neural network
which is trained using single energy
acquired images on the CT Scanner
and designed specifically to
generate high quality CT images.

Utilizes a dedicated neural
network which is trained using
dual energy acquired images on
the CT Scanner and designed
specifically to generate high
quality CT images.

System statistics - Noise
modeling of the data
collection imaging chain
(photon noise and
electronic noise)

Characterization of the photon
statistics as it propagates through
the preprocessing and calibration
imaging chain.

System statistics – Noise
characteristics of the
reconstructed images

Utilizes a trained neural network
which models the scanned object
using information obtained from
extensive phantom and clinical
data.

Select recon type and strength
(Low, Medium, High).

510(k) Premarket Notification Submission – DLIR-GSI


Aquilion Lightning,
TSX‐036A/1, V8.4
(Primary Predicate
Device)

JAK:
System, X‐ray,
Tomography,
Computed

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