Viz CTP is a software package that
provides for the visualization and study
of changes of tissue perfusion in digital
images captured by CT. Viz CTP allows
viewing and quantification.

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

Perfusion CT
Cerebral Blood Flow (CBF)
Yes

Tissue residue function time to peak
(TMax)

CT Tools
Arterial Input Function (AIF)
Yes

Export perfusion files to PACS and
DICOM file systems

Acquire, transmit, process, and store
medical images.


DR 800 (New Device)
Opera Swing (PREDICATE–K140380)

RF FL4343, Pixium 2430 (DR10s),
Pixium 3543 (DR14s)

Gadolinium Oxysulfide (GOS) or
Cesium Iodide (CsI) scintillator

Detector Sizes
Same as predicate
17x17 in.

Pixel Size
Same as predicate
148 (cid:541)m

Static – 2880 x 2880
Dynamic – 1024 x 1024

Operator Workstation
Agfa NX
Diagnostic Workstation

Tilt +/- 90°
240 x 80 cm
265 kg maximum weight

Tilt +/- 90°
240 x 65 cm
227 kg maximum weight

Operating System
Same as predicate
Windows 7, 8, 8.1, 10

Separately cleared medical display (K051901)

The DR 800 systems is indicated for performing
dynamic imaging examinations (fluoroscopy and/or
rapid sequence) of the following
anatomies/procedures: Positioning fluoroscopy
procedures, Gastro-intestinal examinations,
Urogenital tract examinations, and Angiography. It
is intended to replace fluoroscopic images obtained
through intensifier technology. In addition, the
system is intended for project radiography of all
body parts. The DR 800 is not intended for
mammography applications.

The Opera Swing is indicated for
performing general radiography,
fluoroscopy and angiography
procedures/applications. The device is
intended for use in: Skeleton, Chest and
lungs, Pediatrics,
Emergency/traumatology,
Gastroenterology, Urology and
gynecology, Linear tomography, Digital
angiography and Stitching.

Premarket Notification: DR 800 with MUSICA DynamicTM


Clinical Application
Anatomy/Region of Interest

Pediatric Cardiac
P
P
P
P
P
P
P2
P
P
P2
6

Musculo-skeletal Conventional
P
P
P
P
P
P
P
P
P

Musculo-skeletal Superficial
P
P
P
P
P
P
P
P
P

Vascular Access (IV, PICC)
P
P
P
P
P
P
P
P
P
5,7

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:


Vascular Access (IV, PICC)
P
P
P
P
P
P
P
P
7


Vascular Access (IV, PICC)
P
P
P
P
P
P
P
P
P
7


Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body asfollows:


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.

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

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


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

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 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


INTENDED USE
: DIAGNOSTIC ULTRASOUND IMA
GING OR F
LUID FLOW
ANALYSIS O
F THE HUM
AN BODY AS FOLL
OWS:

Clinical Applicati
on
Mode of O
peration

General
Specific
B M
Color
Power
PW
Combined
Other*

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

Fetal Imaging
Fetal
P P
P
P
N
B+M; B+CD;

Intra-operative (Abdominal
P P
P
P
N
B+M; B+CD;
Note 1

Small Organ (Thyroid, Prostate,
P
P
P
N
B+CD; B+PD;
Note 1

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

Musculo-skeletal (Superficial)
P
P
P
N
B+CD; B+PDN
Note 1

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


INTENDED USE:
DIAGNOSTIC ULTRASOUND IMA
GING
OR F
LUID FLOW
ANALYSIS
OF THE HUM
AN BOD

Peripheral
Peripheral Vessel
P
P
P
P
N
B+M; B

FORM FDA 388
1(8/14)Cont'd
P
age 3 of 11


Intra-operative (Abdominal
organs & vascular)

Small Organ (Thyroid, Prostate,
Scrotum, Breast)

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


INTENDED USE:
DIAGNOSTIC ULTRASOUND IMAG
ING OR FL
UID FLOW
ANALYSIS O
F THE HUM
AN BODY A

General
Specific
B M
Color
Power
PW
Combined

Intra-operative (Abdominal
P P
P
P
N
B+M; B+C

Small Organ (Thyroid, Prostate,
P P
P
P
N
B+M; B+C

Musculo-skeletal (Conventional)
P P
P
P
N
B+M; B+C

Other (Urology, Gynecology)
P P
P
P
N
B+M; B+C


INTENDED USE: DIAGNOSTIC ULTRASOUND IMAGING OR

Peripheral Peripheral Vessel P P
P
P N
B+M; B
+CD;


Portable ultrasound system
Portable ultrasound system

Removable battery (Li-ion)
Removable battery (Li-ion)

iOS or Android mobile device
iOS or Android mobile device

Communicates wirelessly via Wi-
Fi and Bluetooth

− Convex Array
− Linear Array
− Phased Array
− Intracavity

Diagnostic ultrasound imaging and
fluid flow analysis

− Ophthalmic
− Fetal
− Abdominal
− Intraoperative (Ab/Vasc)
−
− Pediatric
− Small organ
−
− Adult cephalic
− Trans-rectal
− Trans-vaginal
− Musculo-skel. (Conv.)
− Musculo-skel. (Superfic.)
− Urology
− Gynecology
− Cardiac adult
− Cardiac pediatric
−
−
− Peripheral vessel
− Carotid
− Needle guidance

− Ophthalmic
− Fetal
− Abdominal
− Intraoperative (Ab/Vasc)
−
− Pediatric
− Small organ
−
− Adult cephalic
−
−
− Musculo-skel. (Conv.)
− Musculo-skel. (Superfic.)
− Urology
− Gynecology
− Cardiac adult
− Cardiac pediatric
−
− Fetal echo
− Peripheral vessel
− Carotid
− Needle guidance

− B-mode
− M-mode
− Color Doppler
−
− Power Doppler
− PWD
− CWD
−
− Combined (B+M; B+CD; B+PD;
B+PWD)

− B-mode
− M-mode
− Color Doppler
−
− Power Doppler
−
− CWD
−
− Combined (B+M, B+CD, B+PD)


Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential

(Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety

and Essential Performance (IEC 60601-1:2005, Mod). (General II (ES/EMC))

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential

performance – Collateral Standard: Electromagnetic Capability – Requirements and tests. (4th

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential

performance -Collateral standard: Usability

Medical Electrical Equipment — Part 1-12: General requirements for basic safety and essential

performance - Collateral Standard: Requirements for medical electrical equipment and medical

electrical systems used in the emergency medical services environment

Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential

performance of ultrasonic medical diagnostic and monitoring equipment. (3rd and 4th Edition)

Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes - Safety

Requirements for Portable Sealed Secondary Cells, And for Batteries Made from Them, For Use in

Portable Applications [Including: Corrigendum 1 (2013)]

Consolidated Version Medical Devices - Application of Usability Engineering to Medical Devices

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management

Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity

Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity

Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials

Medical Device Software - Software Life Cycle Processes

Medical Devices - Symbols to be Used with Medical Devices Labels, Labeling, and Information to be

Medical Devices - Applications of Risk Management to Medical Devices

Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment - Revision 3

Nonclinical performance tests show compliance to the following standards:


Vital Images, Inc. hereby submits this traditional 510(k) to provide a
notification submission for proposed software changes in the already
510(k) cleared Vitrea CT Brain Perfusion software (K121213).

Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN, 55343-4414, USA

Susan Atwood
Principal Quality Engineer
Phone: 952-487-9759
Fax: 952-487-9510
E-mail: satwood@vitalimages.com
Alternate Contact Person:
Vince Swenson
Sr. Director of Quality and Regulatory
Phone: 952-487-9548
Fax: 952-487-9510
E-mail: vswenson@vitalimages.com

Device Trade Name:
Vitrea CT Brain Perfusion

Picture Archiving and Communications System

Device Classification
System, Image Processing, Radiological


Predicate Device
Manufacturer
FDA 510(k) Number

Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN 55343
USA


Reference Device
Manufacturer
FDA 510(k) Number

Olea Medical
93 Avenue Des Sorbiers,
Zone Athelia Iv
La Ciotat, FR 13600


Characteristic Subject Predicate Reference Comparison

Classification
Class II
Class II
Class II
Same

Review Panel
Radiology
Radiology
Radiology
Same

Predicate and
reference
devices are
cleared.


Criteria
Subject Device
Predicate Device
Comparison

Vitrea CT Brain Perfusion
with Bayesian Algorithm

Vitrea CT Brain Perfusion is a
non-invasive post-processing
application designed to
evaluate areas of brain
perfusion. The software can
calculate cerebral blood flow
(CBF), cerebral blood volume
(CBV), local bolus timing (i.e.,
delay of tissue response, time
to peak), and mean transit time
(MTT) from dynamic CT image
data acquired after the injection
of contrast media. The package
also allows the calculation of
regions of interest and mirrored
regions, as well as the visual
inspection of time density
curves. Vitrea CT Brain

Indications for Use Comparison with the Predicate Device


Perfusion supports the
physician in visualizing the
apparent blood perfusion in
brain tissue affected by acute
stroke. Areas of decreased
perfusion, as is observed in
acute cerebral infarcts, appear
as areas of changed signal
intensity (lower for both CBF
and CBV and higher for time to
peak and MTT).

Qualified healthcare
professionals including, but not
restricted to, radiologists, non-
radiology specialists,
physicians and technologists.

Patients with suspected
compromised or abnormal
cerebral blood flow.

Traditional 510(k) Pre-market Notification


Quantitative brain perfusion maps
for:
• Regional cerebral blood
volume (rCBV)
• Regional cerebral blood
flow (rCBV)
• Mean transit time (MTT)
• Time to peak of tissue
(TTP)
• Delay of tissue response
(Delay)

Display:
• Region of interest (ROI)
• Mirrored regions
• Time density curves

Similarities in Technology with the Predicate Device


Display of Perfusion Maps in:
• MPR orientations
• 2D
• 3D

4D-DSA (digital subtraction
angiography) view for visualizing
flow of contrast through the vessels

Perfusion maps in MPR orientations
and 2D

Automatic motion correction and
curve fitting

Region of interest (ROI) templates
Yes
Yes
Same

Midline identification and display
Yes
Yes
Same

Manual and automatic detection of
artery and vein locations

Automatic calculation of
quantitative brain perfusion
results

Window leveling, edit mid-plane
line, display mirrored ROIs,
snapshots, time-series batch,
movies for physician reporting

Report generation for the Brain
Perfusion patient study

Perfusion measurement averages
for multiple ROIs with ability to
mirror an ROI from one hemisphere
to the other


Subject device provides user
with choice to use either the
Bayesian algorithm or SVD+
algorithm.
Predicate device can use the
SVD+ algorithm.
Note: The added Bayesian
algorithm in the subject device is
similar to the Bayesian algorithm
in the reference device, Olea
Sphere 3.0, which was cleared
by the FDA under K152602.
Therefore, this added algorithm
does not raise different
questions of safety and
effectiveness.

Differences in Technology with the Predicate Device


Bayesian Algorithm:
The Bayesian estimation of the
hemodynamical parameters
integrates a model-based
approach especially robust to
image noise and fast analytical
integration techniques to compute
the posterior probabilities of the
estimated blood flow, delay, MTT
and time concentration curves
(residue functions).

Automatic Arterial Input function
and Vein Output function

Similarities in Technology with the Reference Device


Automatic Brain Midline detection
Yes
Yes
Same

Noise reduction is applied before
the Bayesian computation.

Model based Bayesian estimation
of perfusion parameters.


Standard No.
Standards
Standard Title
Version
Date

Digital Imaging and
Communications in Medicine
(DICOM) Set (Radiology)

Medical Devices -
Applications of Risk
Management to Medical
Devices

IEC 62304:2006
(Recognition
Number 13-32)

Medical Device Software -
Software Life Cycle
Processes (Software /
Informatics)


Intended Use: Diagnostic ultrasound imaging of the human body as follows:


Uscan Ultrasound System
(This submission)

Diagnostic ultrasound imaging
of the human body

Diagnostic ultrasound imaging
or fluid flow analysis of the
human body

Abdominal
Pediatric
Small Organ (prostate)
Musculo-skeletal
(Conventional)
Peripheral Vessel
Needle guidance

Opthalmic
Fetal – OB/GYN
Abdominal
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal
Musculo-skeletal
(Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Peripheral Vessel
Needle guidance

Linear Array
Curved Linear Array
Intracavitary
Phased Array

2D / B-mode
Tissue Harmonic Imaging
M-mode
Color M-mode
Color Power Doppler
Combination Modes
Velocity Color Doppler

PW Doppler
Not available
Not available
Not available

CW Doppler
Not available
Not available
Not available

fundamental scientific technology. A comparison table is provided below.


Transducers:
ABS+PC (acrylonitrile
butadiene styrene +
polycarbonate)
Cycoloy
Polymethyl Pentene based
Olefin Copolymer
Silicone Rubber RTV
Thermoplastic polyurethane

Transducers:
Cycoloy
Polymethyl Pentene based
Olefin Copolymer
Thermoplastic polyurethane

Transducers:
Acrylonitrile-butadiene-
styrene (ABS)
Cycoloy
Polycarbonate (PC)
Polysulfone
Poly-Vinyl-Chloride (PVC)
Silicone Rubber
Silicone Rubber RTV
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene
(ABS)

Uscan:
Handheld tablet (off-the-shelf)
9.7” Liquid Crystal Display
(LCD)
Operating system: Android
Uscan ultrasound software
running as an “app” on tablet
1 Micro USB port
Dimensions: 9.34”(H) x
6.65”(W) x 0.24”(L)
Weight: 0.39 lbs
System operates via battery
Input: 100 – 240 VAC, 50/60
Hz
Output: 5VDC, 2 A max
Distance calculations
Wireless networking

Uscan:
Handheld tablet (off-the-shelf)
7.86” Liquid Crystal Display
(LCD)
Operating system: Android
Uscan ultrasound software
running as an “app” on tablet
1 Micro USB port
Dimensions: 8.15”(H) x
5.39”(W) x 0.31”(L)
Weight: 0.77 lbs
System operates via battery
Input: 100 – 240 VAC, 50/60
Hz
Output: 12VDC, 1.5 A max
Distance, volume calculations
Wireless networking

SII:
Handheld display and control
12.1” Liquid Crystal Display
(LCD)
Operating system: Windows
CE
3 USB ports
Dimensions: 4.8”(H) x
11.5”(W) x 17.6”(L)
Weight: 12.6 lbs
System operates via battery or
AC power
Input: 100 – 240V options,
50/60 Hz
Output: 15VDC
Various obstetrical, cardiac,
volume, and M-mode
measurement and calculation
packages
Wireless networking


AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of
medical devices – Part 1: Evaluation and testing within a risk management
process

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012
and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment -
Part 1: General requirements for basic safety and essential performance
(IEC 60601-1:2005, MOD)

AAMI / ANSI / IEC 60601-1-2:2014, Medical electrical equipment – Part
1-2: General requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility - Requirements and
tests

IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment – Part
1-6: General requirements for basic safety and essential performance -
Collateral standard: Usability

IEC 60601-2-37:2015 Edition 2.1, Medical electrical equipment – Part 2-
37: Particular requirements for the basic safety and essential performance
of ultrasonic medical diagnostic and monitoring equipment

AAMI / ANSI / IEC 62304:2006, Medical device software - Software life
cycle processes

AAMI / ANSI / IEC 62366-1:2015, Medical devices – Part 1: Application
of usability engineering to medical devices

ISO 14971:2007, Medical devices - Application of risk management to
medical devices

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


Radiological Computer Assisted Detection and
Diagnosis Software

Classification regulation
21 CFR 892.2090


Legal Manufacturer
Imagen Technologies, Inc.


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

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


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

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

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

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


automatically processes mammograms and the output of the device can be

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


Standard ID
Standard Title
FDA Recognition #

Medical Devices - Application Of Risk
Management To Medical Devices

Medical Device Software - Software Life
Cycle Processes

Evaluation of automatic class III
designation for OsteoDetect – Decision
summary with special controls


Lorad Selenia (Hologic) and Mammomat Inspiration devices. The selected

cases consisted of series of consecutive samples. The study set included 100 cases with

cancer, 40 false positive recalls from screening, and 100 normal exams.

mammograms of asymptomatic women that were retrospectively collected at two clinical


LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC
NAVIGATION (VBN) SOFTWARE

ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5


Kolonel Begaultlaan 1b/12
3012 Leuven
Belgium


Common Name
Medical Image Processing Software

Classification Name
System, Image processing, Radiological


(cid:72)(cid:3)(Select one or both, as applicable)

“An agency may not conduct or sponsor, and a person is not required to re

information unless it displays a currently valid OMB num


51 Federal St. Suite 305
San Francisco, CA 94107

Email: regulatory@arterys.com
Phone: 403-923-9688


Classification Name
System, Image Processing, Radiological


Primary Predicate Device
Arterys Viewer, K171544

Secondary Predicate Device
Arterys Cardio DL, K163253

Tertiary Predicate Device
Arterys Oncology DL, K173542


Primary
Predicate
Arterys Viewer
(K171544)

Secondary
Predicate
Arterys Cardio
DL (K163253)

Tertiary Predicate
Arterys Oncology
DL (K173542)

Ability to load
different
optional modules
from same
worklist

Yes - all three modules
are in drop down menu

Client server architecture
using Linux server and
web browser client

Viewer: MR, CT
Cardio: MR
Onco: MR and CT

Yes. Added tags for
further identification.

Table 5.1: Technological characteristics of the proposed device and predicate devices


Pan, zoom, rotate,
maximize/minimize, slice
scroll (view multiple
slices), adjust
window/level, slab
thickness, time scroll
(view multiple phases)

Yes. Flow direction and
2D speed color map

Yes. Added multi-study
and that images are now
commonly aligned.

Patient, study,
orientation, and pixel
information

Yes - linear, area, and
volume for all three
modules.

Semi-automated
segmentation of
region of interest

Cardio
Visualization,
Quantification,
Volume in 4D
Flow

Yes. Added normalized
volume measurements
based on age and gender.
Added ability to edit the
valve plane to adjust
volume.

Yes - Automatically
identified + user editable.
Added ability to edit the
valve plane to adjust
volume.

Cardio
Visualization,
Quantification,
Volume in 3D
Workflow for a
short axis stack


Yes. Added minimal
content configurability.

Onco
Longitudinal
tracking - linked
VOIs between
timepoints


Modality RAPID Map Lesion DBF/DWI Tmax
Volume Threshold Volume Threshold Mismatch
(rCBF/ADC) (ml) (sec) Ratio*

CTP Mismatch CBF/Tmax <0.3 ≤ 70 > 6 ≥ 1.2 CBF
MRI Mismatch DWI/Tmax <620 ≤ 50 > 6 ≥ 1.8 DWI

CTP Mismatch CBF/Tmax <0.3 ≤ 70 > 6 ≥ 1.8 CBF
MRI Mismatch DWI/Tmax <620 ≤ 70 > 6 ≥ 1.8 DWI

CTP Mismatch CBF <0.3 ≤ 20 NA NA
MRI Mismatch/DWI DWI <620 ≤ 20 NA NA

CTP Mismatch CBF <0.3 ≤ 30 NA NA
MRI Mismatch/DWI DWI <620 ≤ 30 NA NA

CTP Mismatch CBF <0.3 ≤ 50 NA NA
MRI Mismatch/DWI DWI <620 ≤ 50 NA NA

*Note: A Mismatch volume ≥ 15ml is recommended


physician, and have none of the following contraindications or
exclusions.
Contraindications/Exclusions:
• Bolus Quality: absent or inadequate bolus.
• Patient Motion: excessive motion leading to artifacts that
make the scan technically inadequate.
• Presence of Hemorrhage.

View, process and analyze medical images. Performs standard
PACS functions with respect to querying and listing.

Standard off-the-shelf PC workstation/server

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

Acquires medical image data from DICOM compliant
imaging devices and modalities

Computed Tomography (CT) via DICOM Format

Magnetic Image Resonance (MRI) via DICOM Format

Dynamic Analysis tissue flow (perfusion) and tissue blood volume

Diffusion MRI
Isotropic DWI (isoDWI)
Same

Fractional Anisotropy (FA) and color FA
Same


Tissue residue function time to peak (Tmax)

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

Region of interest (ROI) and Volumetry
Same

Volumetric comparison between 2 ROIs
Same

Export perfusion and diffusion files to PACS and
DICOM file systems

Acquire, transmit, process, and store medical
images


Notification-only, parallel workflow
tool

Hospital networks and trained
clinicians

Identify patients with a pre-
specified clinical condition

Cerebrovascular Event:
Intracranial hemorrhage

Cerebrovascular Event: Large
vessel occlusion

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

Independent of standard of care
workflow

Artificial Intelligence algorithm
Yes
Yes

Limited to analysis of imaging data
Yes
Yes

Aids prompt identification of
cases with indicated findings

Suspected hemorrhage / No
suspected hemorrhage

Where results are received
PACS / Workstation
PACS / Mobile application

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


This Summary has been prepared in acc
ordance with 21 CFR 807.9

Submitted by
Resonance Health Analysis Se

Resonance Health Analysis Services Pty Ltd


892.1001 Liver Iron Concentration Imaging Companion
Diagnostic For Deferasirox


Proposed Device
Predicate Device
Reference Device

FerriSmart
FerriSmart
FerriScan R2-MRI
FerriScan R2-MRI

Liver Iron Concentration
Imaging Companion
Diagnostic For
Deferasirox

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

Standalone software
package that
automatically analyses
multi-slice, spin-echo
MRI data sets
encompassing the
abdomen to provide
objective and
reproducible
determination of liver
parameters to support
clinicians in the
assessment of liver iron
status.
The software tool
determines the signal
decay rate (R ) that is
2
used to characterize iron
loading in the liver,
which is then transformed
by a defined calibration
curve to provide a

Software tool to facilitate
the import and
visualization of
multi-slice, spin-echo
MRI data sets
encompassing the
abdomen, with
functionality independent
of the MRI equipment
vendor, to provide
objective and
reproducible
determination of liver
parameters to support
clinicians in the
assessment of liver iron
status.
The software tool also
calculates the signal
decay rate (R ) that is
2
used to characterize iron
loading in the liver,
which is then transformed
by a defined calibration


by a defined calibration
curve to provide a
quantitative measure of
liver iron concentrations
in vivo.

Convolutional neural
networks for the image
analysis.
Algorithmic for the
images quality checks
and R conversion into
2
LIC.

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

1. Supporting clinical
diagnoses about the status
of liver iron
concentration.
2. Supporting the
subsequent clinical
decision-making
processes.
3. Supporting the use in
clinical research trials,
directed at studying
changes in liver iron
concentration 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.

For the analysis of multi-
slice, spin-echo MRI data
sets of the liver for the
measurement of liver R
2
and liver iron
concentration and to
assist in the provision of
iron chelation therapy

Measurement of R and
2
iron concentration in the
liver from MRI scans.

Indicated to:
• measure liver iron
concentration in
individuals with

Measure liver iron
concentration to aid in
the identification and
monitoring of non-
transfusion-dependent

The R2-MRI Analysis
System is an accessory
diagnostic device to MRI
scanners and is intended
for diagnostic use to


Proposed Device
Predicate Device
Reference Device

FerriSmart
FerriSmart
FerriScan R2-MRI
FerriScan R2-MRI

confirmed or
suspected systemic
iron overload;
• monitor liver iron
burden in transfusion
dependent
thalassemia patients
and patients with
sickle cell disease
receiving blood
transfusions;.
• aid in the
identification and
monitoring of non-
transfusion-dependent
thalassemia patients
receiving therapy
with deferasirox.

present images that
reflect the magnetic
resonance spectra for the
determination of iron on
the liver.


Sensitivities and specificities of FerriSmart for predicting FerriScan LIC values greater than several

The sensitivities and specificities results are presented in the Table below.


DMS No:
Mtk3252-007-1
Rev. Date:
3rd Aug 2018

Title:
Volpara Imaging Software 510(k) Summary


Predicate Device
Volpara 1.5.2 (K153427)

VolparaDensity is a software
application intended for use with
the raw data from digital breast x-
ray systems, including
tomosynthesis. VolparaDensity
calculates and quantifies a density
map and from that determines
volumetric breast density as a ratio
of fibroglandular tissue and total
breast volume estimates. Volpara
provides these numerical values
along with a BI-RADS breast
density 4th or 5th Edition category
to aid health care professionals in
the assessment of breast tissue
composition. VolparaDensity is not
an interpretive or diagnostic aid
and should be used only as
adjunctive information when the
final assessment of breast density
category is made by an MQSA-
qualified interpreting physician.

Intended Users
Health Care Professionals.
Health Care Professionals.

Image Source
Digital mammography images.
Digital mammography images.

Digital mammograms from
mammography or tomosynthesis
systems.

Digital mammograms from
mammography or tomosynthesis
systems, including those obtained
using with curved paddles.

Volume of Fibroglandular tissue
Volume of Breast
Volumetric Breast Density
BIRADS 4th or 5th Edition Breast
Density Category
Average thickness of dense tissue
Maximum thickness of dense
tissue (and location).

Volume of Fibroglandular tissue
Volume of Breast
Volumetric Breast Density
BIRADS 4th or 5th Edition Breast
Density Category, with highlighting
above a certain volumetric
threshold or if focal density present
Average thickness of dense tissue

Substantial Equivalence Comparison Table


Maximum thickness of dense
tissue (and location).
Maximum volume of dense tissue
above any 1cm2 square region
(and location).
Image quality assessment metrics

Density map in DICOM SCI format,
for visualization as user specifies.

Classification
21 CFR 892.2050; LLZ
21 CFR 892.2050; LLZ

Software Level of Concern
Moderate
Moderate

Title: Volpara Imaging Software 510(k) Summary


880 Santa Cruz Ave, Suite 200
Menlo Park, CA 94025

Picture archiving and communications system

Trade name: Sapheneia Clarity
Manufacturer: Sapheneia Commercial Products AB
Address: Teknikringen 8
SE-583 30 Linkoping, Sweden
Regulation Number: 21 CFR 892.2050
Regulation Name: Picture Archiving and
Communications System
Device Class: Class II
Product Code: LLZ
510(k) Number: K063391
510(k) Clearance Date: April 26, 2007


Software package that operates on
off-the-shelf hardware

Software package that operates
on a virtual machine (VM)

Onsite on the facility VM
and/or offsite on the cloud VM,
depending on the site’s
configuration

The software processes DICOM
compliant image data

Table 5-2. Summary of Technological Characteristics Comparison.


Multi-modality; specifically
processes PET, PET/CT and
PET/MR images

The software is designed for use
on a radiology workstation. It is
unknown whether there is a user
interface.

None – enhanced images are
viewed on existing PACS
workstations

Protocols
Custom low dose protocols
Standard scanner protocols

Sapheneia ClarityTM employs a
sophisticated statistical analysis
of the image structure in the
neighborhood of each pixel.
Using robust estimation methods
the dominant structures are
separated from the embedding
noise. Once the structure has been
determined, it is possible to
strengthen the interesting parts
while simultaneously reducing the
noise.

The software employs a
convolutional neural network-
based method in a pixel’s
neighborhood to generate the
value for each pixel.
Using a residual learning
approach, the software predicts
the noise components and
structural components. The
software separates these
components, which enhances
the structure while
simultaneously reducing the
noise.

The acquisition remains the same,
i.e. the image processing can be
generated from multiple
modalities and with predefined or
specific acquisition protocol
settings.


OsteoDetect
Imagen
DEN180005
May 24, 2018


Subject Device
iCAD Inc.
®
PowerLook Tomo Detection V2
Software

Predicate Device
Imagen Inc.
OsteoDetect
DEN180005

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.

®
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 calcifications that may be confirmed or dismissed by
the interpreting physician.

OsteoDetect analyzes wrist radiographs
using machine learning techniques to identify
and highlight distal radius fractures during
the review of posterior-anterior (PA) and
lateral (LAT) radiographs of adult wrists.

Both devices have the same
intended use per 21 CFR
892.2090.


Radiological computer assisted detection and
diagnostic software

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

Image processing device intended to aid in
identifying and highlighting distal radius
fractures during the review of posterior-
anterior (PA) and lateral (LAT) radiographs
of adult wrists.

Both devices are intended to aid in the
detection, localization, and characterization
of disease specific findings on acquired
medical images per 21 CFR 892.2090.
PLTD detects a different disease specific
finding. However, special controls are in
place to mitigate any risk for this difference.

To inform the primary diagnostic and patient
management decisions that are made by the
clinical user.

The outputs of both devices serve as a
concurrent read. The output is used to
inform the clinical user (who themselves
make the primary diagnostic and patient
management decisions) and will not replace
the clinical expertise and judgment of the
clinical user.

Symptomatic and asymptomatic women
undergoing mammography.

Adult men and women undergoing
radiographs of adult wrists.

PLTD is intended for a different patient
population however special controls are
in place to mitigate any risk for this
difference.

End Users
Interpreting Physicians Radiologists
Clinicians
Same

The Image Source Modalities are different.
However, special controls are in place to
mitigate any risk for this difference.

Output Device
Softcopy Workstation
Softcopy Workstation, PACS, RIS


In accordance with 21 CFR 8
07.92 the fol

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


Centricity Universal
Centricity Universal

Centricity Universal
Viewer is a device that
displays medical images
and data from various
imaging sources, and
from other healthcare
information sources.
Medical images and data
can be displayed,
communicated, stored,
and processed.
Typical users of this
system are authorized
healthcare professionals.
Centricity Universal
Viewer is intended to
assist in the viewing,
analysis, diagnostic
interpretation, and
sharing of images and
other information.
Mammography images
may only be interpreted
using a monitor
compliant with
requirements of local
regulations and must
meet other technical
specifications reviewed
and accepted by the
local regulatory
agencies.

Centricity Universal Viewer
is contraindicated for the
use of lossy compressed
mammographic images.


Lossy compressed
mammographic images
and digitized film screen
images must not be
reviewed for primary image
interpretations.

Supported in the
subject device.
The following tools
are available to help
perform an analysis
of images received
as a result of a
catheterization
procedure:
1. Stenosis Analysis
2. Left ventricular
analysis
3. Catheter
calibration
 Point to Point
Calibration
 Calibration
extension
4. Distance
measurement

Equivalent. Cath
Tools modifications
do not change the
Intended Use. The
Cath Tools
functionality added is
identical to the Cath
Tools in GE
Healthcare’s,
Centricity Radiology
RA600, Cardiology
CA1000 cleared
under K063628. Test
results for these
modifications do not
raise different issues
of safety or
effectiveness. There
are no new potential
hazards and no
changes to existing
potential hazards,
and no change in the
final risk ratings for
the device.

Search by:
1. Patient name
2. ID
3. Accession Number
4. Study date
5. Study description
6. Modality
7. Study status
8. Referring Physician
9. Date of Birth
10. Referring Service

Same as predicate,
except:
- Retrieval of off-
line study
- Access to
confidential
patient studies
based on
privileges
- Increase number
of studies the

Equivalent. Adding
the modifications
under interactive
search for studies
does not impact the
device safety and
effectiveness.


11. Priority
12. Online status (CPACS
only)
13. 0 image studies
(CPACS only)
14. Performing physician
15. Location (Enterprise
Archive (EA) only for
Cardiology)

worklist can
display and
remove 30 study
limit on custom
worklists
- Support for
Technologist
study verification
workflow and
teaching folder
- Create, access,
save and display
key images

Search for studies
located on the external
DICOM compliant server.
Supported only on IW
backend

Same as predicate,
except:
- search and
retrieve prior
exams from
external DICOM
server
- save and display
DICOM grayscale
presentation
state object to
work with any
type of under
lying hanging
protocol

Equivalent. Adding
the modifications
under the search
from DICOM server
does not impact the
device safety and
effectiveness.

Ability to display the
following:
1. Image
2. Report
3. Patient information
4. Exam information
5. DICOM Header
information
6. GSPS
7. RPPS
8. FCE
9. Key Image Notes
10. Exam Notes

Same as predicate,
except:
- native support of
diagnostic
interpretation for
2D and DBT
mammo images
- user, group and
system level step
protocols
- support DICOM
metadata in
overlay /

Equivalent. These
modifications do not
change the Intended
Use. The device
continues to support
the display, storage,
analysis and
processing of various
medical images using
a similar technology.
Test results for these
modifications do not
raise different issues


Centricity Universal
Centricity Universal

11. Modality and VOI LUT
12. Structured Reports

annotation editor
- support
synchronized ECG
curve, ECG scroll
and ECG curve
height selector
- support Dorsal
view (Reverse
ACR IHE) for
mammography

of safety or
effectiveness. There
are no new potential
hazards and no
changes to existing
potential hazards,
and no change in the
final risk ratings for
the device.

1. Line
2. Angle
3. SUV
4. OB Measurements
5. Digital Subtraction
Angiography (DSA)
6. Triangulation
7. MIP/MPR
8. Spine Labeling
9. Using "imager pixel
spacing" - DICOM field to
enable measurements
across all CR/DX/US
exams.
10. Cardio Thoracic Ratio
(CTR)
11. Image Annotations

Same as predicate,
except:
- Automatically
mark images as
key when image is
annotated
- Use “imager pixel
spacing” DICOM
field to enable
measurements
across CR/DX/US
exams

Equivalent. Adding
the modifications for
image annotations
and measurements
does not impact the
device safety and
effectiveness. These
enhancements
provide information
already available to
be used in the same
way as the predicate,
for the same purpose
and by the same
users.

Smart Reading Protocols
-Regular Hanging
protocols to launch
multiple MIP/MPRs

Same as predicate,
except:
- multi-modality and
multi-vendor
hanging protocol
- dedicated toolbar
for mammography
features
- smart reading
protocols learn
user’s preferences
for MRI
multiphasic
studies

Equivalent. Adding
the modifications for
customized hanging
protocols does not
impact the device
safety and
effectiveness. These
enhancements
provide information
to be used in the
same way as the
predicate, for the
same purpose and by
the same users.

Maximum Intensity
Projection (MIP) MIP with


Projection (MIP)
MIP with
interactive
window-level
clipping volume
of interest,
zoom, pan, and
rotate

- Recalculate
standard update
value on the fly for
PET/CT images
- Multi-planar
reconstruction
support multiple
oblique
reconstruction
- Support for non-
square pixel image
calibration

change the Intended
Use. The device
continues to support
the display, storage,
analysis and
processing of various
medical images using
a similar technology.
Test results for these
modifications do not
raise different issues
of safety or
effectiveness. There
are no new potential
hazards and no
changes to existing
potential hazards,
and no change in the
final risk ratings for
the device.

Created Print Pages from
selected Key Images,
one-click placement;
customized templates;
one click-full screen
snapshot

Generic interface to
integrate outbound with
third party applications
and internal GEHC
applications that meet
the interface
requirements.

Same as predicate,
except:
- Update to API
connectivity to
launch newer
versions of 3rd
party software

Equivalent. Adding
modifications for the
interfaces does not
impact the device
safety and
effectiveness. There
are no new potential


Centricity Universal
Centricity Universal

applications such
as GE Healthcare’s
EchoPAC and
Advantage
Workstation
applications

hazards and no
changes to existing
potential hazards,
and no change in the
final risk ratings for
the device.

The viewer can be
launched via a 3rd party
application using the
following methods:
1. url launch
2. IVAPI
3. Inbound API

Same as predicate,
except:
- Updates in
interfaces with 3rd
party software
applications
- URL launch using
SUID when study
associated with
multiple orders

Equivalent. Adding
modifications under
external system
launch does not
impact the device
safety and
effectiveness. These
enhancements
provide information
to be used in the
same way as the
predicate, for the
same purpose and by
the same users.

User Interface
and User
Manual
Languages

1. English, 2. German,
3. Japanese, 4. French,
5. Simplified Chinese
6. Italian, 7. Polish, 8.
Spanish
9. Turkish, 10. Brazilian
Portuguese, 11. Dutch,
12. Swedish, 13. Russian
14. Korean, 15. Finnish,
16. Danish, 17.
Norwegian,
18. Traditional Chinese
19. Portuguese, 20.
Greek,
21. Hungarian


Same as predicate,
except:
- auto refresh and
notification when
new images arrive
- merge two studies
into one
- audit log to track
export of images

Equivalent. Adding
modifications under
automatic
notification
messages does not
impact the device
safety and
effectiveness. These
enhancements
provide information
to be used in the
same way as the
predicate, for the
same purpose and by
the same users.

Wavelet compression
1. JPEG2000 lossless
2. JPEG2000 lossy
Non-wavelet
compression
1. JPEG lossless
2. JPEG lossy
JPEG2000 lossless for
images received
uncompressed

1. Turnkey solution
(GEHC IT provides both
the software and
hardware required to
function as a complete
system)
2. Software only solution
(GEHC IT provides and
deploys the Software).


Operating
System for
Diagnostic
Workstation

Microsoft™ Windows 7 -
64 bit
Microsoft™ Windows 8.1
- 64 bit

Same as predicate,
except:
- adding support for
Windows 10
operating system
32 or 64 bit with
Internet Explorer
11

Equivalent. Adding
support for Windows
10 operating system
32 or 64 bit with
Internet Explorer 11
does not impact the
device safety and
effectiveness.

Minimum
Hardware
requirement for
Diagnostic
Workstation

2 Quad-core processor of
2.0
GHz or more
8GB RAM minimum
146GB drive in Raid 0
configuration
DVD-RW Optical drive
One 1GB NIC
10/100/1000 Mb
Ethernet
network
4 Mbps and faster TCP-IP
network

User
Authentication
using a 3rd
Party
Authentication
Server

Same as predicate,
except:
- Provides common
authentication
- security
hardening and
cybersecurity
improvements

Equivalent. Adding
common
authentication
support and security
hardening does not
impact the device
safety and
effectiveness.

1. Supports DICOM SOP
classes
2. Receive images -
DICOM storage SCP
3. Support DICOM 3.0
input
4. gray scale

Same as predicate,
except:
- support additional
color (YBR)
interpretations
with US images
- support saving

Equivalent. Adding
modifications under
DICOM protocol does
not impact the device
safety and
effectiveness. These
enhancements


Centricity Universal
Centricity Universal

image calibration
information in
Presentation
State

provide information
to be used in the
same way as the
predicate, for the
same purpose and by
the same users.

Provides the ability to
view patient information
across multiple
enterprise sites based on
matching patient ID
numbers.

Same as predicate,
except:
- New API to access
patient history in
FHIR format and
from different
sources
- Enhance ability to
group studies
anatomically
- matching patient
studies from
remote sites with
the same patient

Equivalent. Adding
modifications under
cross enterprise
display does not
impact the device
safety and
effectiveness. These
enhancements allow
patient history to be
used in the same way
as the predicate, for
the same purpose
and by the same
users.

Designed to be utilized
inside and outside of
radiology and cardiology


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BBBBrrrraaaaiiiinnnn
A
0.96 ± 0.01
1.7 ± 1.3

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comparison. The results are summarized below.


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Lower Limit of Exact
95% Confidence
Intervals

Two-Sided Exact 95% Exact Confidence Intervals


JAK:
System, X‐ray,
Tomography,
Computed


Aquilion Precision
(TSX‐304A/1 and 2) V8.8 with AiCE

Aquilion Precision
(TSX‐304A/2) V8.6
K173468

Anatomical Region
Whole Body (FBP, AIDR 3D, FIRST)
Whole Body (FBP, AIDR 3D, FIRST)


Wall Thickness,
tested range 1.0 - 9.0mm

Plaque Burden,
tested range 0.4 -1.0 (ratio)

Calcified Area,
tested range 0.0 - 51.2mm2


recorded. The average of all distances and its standard deviation are detailed in the table below:


Orientation
45
1.00 Degrees
0.90 Degrees

The table below summarizes the test data:


Version
cases
2mm
2 mm
TN
FP
FN
Sensitivity
Specificity


Allows for importing of digital
imaging sets

Uses proprietary software
algorithm for 3D image
processing

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

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

SIS Software Technological Characteristics Comparison Table


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

available information; but
these features are
already supported by the
predicate.

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

Results can be uploaded to
planning system

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

Processes images to
enable cross-registration
or cross-referencing.

Cross-registration of two
multi-modality images and
creation of 3D (fused) model

Uploading and viewing
images via web-based portal
or directly via separately
cleared PACS

Yes; supported by
testing
demonstrating new
feature does not
alter device output
compared to
predicate device


Aquilion ONE
(TSX‐305A/3) V8.3 with
FIRST 2.1
(Primary Predicate
Device)

JAK:
System, X‐ray,
Tomography,
Computed


Aquilion ONE (TSX‐305A/3) V8.3 with
FIRST 2.1 (K170177)

AIDR 3D
(Whole Body)
FIRST
(Abdomen, pelvis, lung, cardiac,
extremities and head)

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

Console CKCN‐018A/3
I‐REC BOX (FIRST only)

Display console kit
CGS‐94A (Optional)*
CGS‐75A (Optional)


Characteristic
MRCP+v1 (Subject)
IQQA-Liver (Predicate)

MRCP+v1 is indicated for use as a software-
based image processing system for non-
invasive, quantitative assessment of biliary
system structures by facilitating the
generation, visualisation and review of
three-dimensional quantitative biliary
system models and anatomical image data.

IQQA-Liver Multimodality is a PC-based, self-
contained, non-invasive image analysis
software application for reviewing multiphase
images derived from CT scanners and MR
scanners. Combining image viewing,
processing and reporting tools, the software is
designed to support the visualization,


MRCP+v1 calculates quantitative three-
dimensional biliary system models that
enable measurement of bile duct widths and
automatic detection of regions of variation
(ROV) of tubular structures. MRCP+v1
includes tools for interactive segmentation
and labelling of the biliary system and
tubular structures. MRCP+v1 allows for
regional volumetric analysis of segmented
tree-like, tubular structures and the
gallbladder.
Combining image viewing, processing and
reporting tools, the metrics provided is
designed to support physicians in the
visualization, evaluation and reporting of
hepatobiliary structures. These models and
the physical parameters derived from the
models, when interpreted by a trained
physician, yield information that may assist
in biliary system assessment.
MRCP+v1 is designed to utilize DICOM
compliant MRCP datasets, acquired on
supported MR scanners using supported
MRCP acquisition protocols.
MRCP+v1 is suitable for all patients not
contra-indicated for MRI.

evaluation and reporting of liver and
physician-identified lesions.
The software supports a workflow based on
automated image registration for viewing and
analysing multiphase volume datasets. It
includes tools for interactive segmentation
and labelling of liver segments and vascular
structures.
The software provides functionalities for
manual or interactive segmentation of
physician-identified lesions, interactive
definition of virtual resection plane, and
allows for regional volumetric analysis of such
lesions in terms of size, position, margin and
enhancement pattern, providing information
for physician's evaluation and treatment
planning.
The software is designed for use by trained
professionals, including physicians and
technicians.
Image source: DICOM.

Patients suitable to undergo an MRI scan and
not contra-indicated for MRI.

Patients suitable to undergo an MRI/CT scan
and not contra-indicated for MRI/CT.

Trained operator with a background in
radiological anatomy, such as an MR
radiographer/ MR technician.

Trained professionals, including physicians
and technicians.

Interpreting clinician, reporting radiologist

Installation of MRCP+v1 is controlled and
installed on general purpose workstations. In
the context of use, MRCP+v1 reports are
made available through existing MDDS
software devices.

IQQA-Liver is accessed from a cloud-based
server.

Abdomen, liver, biliary tree, gallbladder

Software only application. The device, a
standalone software application, does not
deliver or depend on energy delivered to or
from patients.


Standalone software application to facilitate
the import and visualization of MR data sets
encompassing the abdomen, including the
liver with functionality independent of the
MRI equipment vendor.
Combining image viewing, processing and
reporting tools, the metrics provided are
designed to support physicians in the
visualization, evaluation and reporting of
hepatobiliary structures.

Standalone software application to facilitate
the import and visualization of MR and CT
data sets encompassing the abdomen,
including the liver with functionality
independent of the OEM equipment vendor.
Combining image processing, viewing and
reporting tools, the software supports the
visualization, evaluation and reporting of body
imaging scans and physician identified lesions.

MRCP+v1 calculates quantitative three-
dimensional biliary system models that
enable measurement of bile duct widths and
automatic detection of regions of variation
(ROV) of tubular structures. MRCP+v1
includes tools for interactive segmentation
and labelling of the biliary system and
tubular structures. MRCP+v1 allows for
regional volumetric analysis of segmented
tree-like, tubular structures and the
gallbladder.

Manual or interactive segmentation of
physician-identified lesions and allows for
regional volumetric analysis of such lesions in
terms of size, position, margin and
enhancement pattern.

Installation of MRCP+v1 is controlled and is
installed on general purpose workstations
within a controlled networked environment.
MRCP+v1 reads in local files compliant with
DICOM 3.0.

Cloud -based server access requiring a
networked computer with the hospital
intranet.
Reads in DICOM 3.0 compliant MR data from
CT/ MRI scanners.

Validated with digital synthetic
phantoms/raw data, phantom scans, and in-
vivo scans.

Experimental results on simulated images
containing structures of interest. Phantom
data. Retrospective in-vivo data.

Validated across all supported
manufacturers.

Materials
Not applicable, standalone software.
Not applicable, standalone software.

Biocompatibility
Not applicable, standalone software.
Not applicable, standalone software.

Sterility
Not applicable, standalone software.
Not applicable, standalone software.

Chemical Safety
Not applicable, standalone software.
Not applicable, standalone software.

Thermal Safety
Not applicable, standalone software.
Not applicable, standalone software.

Radiation Safety
Not applicable, standalone software.
Not applicable, standalone software.


Characteristic
MRCP+v1 (Subject)
IQQA-Liver (Predicate)

Manufacturer
Perspectum Diagnostics Ltd
EDDA Technologies

No new concerns with regards to safety and effectiveness are raised due to different manufacturer. Perspectum
Diagnostics Ltd designed and manufactured MRCP+v1 under a QSR complaint quality management system using
appropriate design controls and an ISO 14971 compliant risk management process. MRCP+v1 underwent a
substantive performance evaluation.

MRCP+v1 is indicated for use as a software-

IQQA-Liver Multimodality is a PC-based, self-

based image processing system for non-
contained, non-invasive image analysis

invasive, quantitative assessment of biliary

software application for reviewing multiphase

system structures by facilitating the
images derived from CT scanners and MR

generation, visualisation and review of
scanners. Combining image viewing,

processing and reporting tools, the software is

system models and anatomical image data.

MRCP+v1 calculates quantitative three-
physician-identified lesions.

enable measurement of bile duct widths and

The software supports a workflow based on

automatic detection of regions of variation

automated image registration for viewing and

analysing multiphase volume datasets. It

includes tools for interactive segmentation

and labelling of liver segments and vascular

tubular structures. MRCP+v1 allows for
structures.

regional volumetric analysis of segmented

The software provides functionalities for

gallbladder.
manual or interactive segmentation of

definition of virtual resection plane, and

reporting tools, the metrics provided is

allows for regional volumetric analysis of such

lesions in terms of size, position, margin and

visualization, evaluation and reporting of

enhancement pattern, providing information

hepatobiliary structures. These models and

for physician's evaluation and treatment

the physical parameters derived from the

physician, yield information that may assist

The software is designed for use by trained

in biliary system assessment.
professionals, including physicians and

compliant MRCP datasets, acquired on
Image source: DICOM.

MRCP+v1 is suitable for all patients not

Similar intended use and therefore does not raise any new concerns with regards to safety and effectiveness.

Indicted for use in the general population for

any patients that are not contra-indicated for

why the differences do not impact safety and effectiveness.


MRCP+v1 underwent bench performance testing on the following MR Systems:


Algorithmic Accuracy Digital Synthetic Data

phantoms, a dataset of digital synthetic data. The results of which are summarized below:


MRCP+v1 underwent in-vivo performance testing on the following MR Systems:


GE Medical Systems, LLC
3000 N. Grandview Blvd
Waukesha, WI 53188, USA

Camille Vidal
Director of Regulatory Affairs Strategy
GE Healthcare
240‐280‐5356
Camille.Vidal@ge.com

Diane Uriell
Regulatory Affairs Director
GE Healthcare
262‐290‐8218
Diane.Uriell@ge.com

Class II, Radiological Computer Assisted Triage and Notification Software,
21 CFR 892.2080
QFM

HealthPNX by Zebra Medical Vision, K190362
Class II, 21 CFR 892.2080, Product code: QFM


Critical Care Suite is a computer aided triage and notification device that
analyzes frontal chest x‐ray images for the presence of prespecified
critical findings (pneumothorax). Critical Care Suite identifies images with
critical findings to enable case prioritization or triage in the
PACS/workstation.
Critical Care Suite is intended for notification only and does not provide
diagnostic information beyond the notification. Critical Care Suite should
not be used in‐lieu of full patient evaluation or solely relied upon to make
or confirm a diagnosis. It is not intended to replace the review of the x‐
ray image by a qualified physician.
Critical Care Suite is indicated for adult‐size patients.

Critical Care Suite is a software module that employs AI‐based image
analysis algorithms to identify pre‐specified critical findings
(pneumothorax) in frontal chest X‐ray images and flag the images in the
PACS/workstation to enable prioritized review by the radiologist.
Critical Care Suite employs a sequence of vendor and system agnostic AI
algorithms to ensure that the input images are suitable for the
pneumothorax detection algorithm and to detect the presence of
pneumothorax in frontal chest X‐rays:
‐ The Quality Care Suite algorithms conduct an automated check
to confirm that the input image is compatible with the
pneumothorax detection algorithm and that the lung field
coverage is adequate;
‐ the PTX Classifier determines whether a pneumothorax is
present in the image.
If a pneumothorax is detected, Critical Care Suite enables case
prioritization or triage through direct communication of the Critical Care
Suite notification during image transfer to the PACS. It can also produce
a Secondary Capture DICOM Image that presents the AI results to the
radiologist.
When deployed on a Digital Projection Radiographic Systems such as
Optima XR240amx, Critical Care Suite is automatically run after image
acquisition. Quality Care Suite algorithms produce an on‐device
notification if the lung field has atypical positioning to give the

510(k) Premarket Notification Submission


Radiological Computer Assisted Triage and
Notification software,
Class II, QFM

Targeted clinical
condition, anatomy
and modality

Pneumothorax
Chest/Lung
Frontal Chest X-ray

Quality Care Suitealgorithms conduct an
automated check to confirm image is
compatible with processing algorithm (age,
frontal chest, lung field)
Atypical lung field positioning generates
notifications on the X-ray system and
Secondary Capture DICOM Image when
generated.

Validation feature of HealthPNX verifies that
input age, modality and view to ensure
compatibility with processing algorithm.
In case of failure during data validation, system
outputs an error code.

AI algorithm designed to detect pneumothorax
in frontal chest X-ray images
Critical Care Suite uses a vendor agnostic
algorithm compatible with DICOM frontal
chest X-ray images acquired on fixed or mobile
systems.

AI algorithm designed to detect pneumothorax
in chest X-ray images.
HealthPNX employs a vendor agnostic
algorithm compatible with DICOM chest X-ray
images.

Critical Care Suite is designed as a software
module that can be deployed on several
computing and X-ray imaging platforms such
as Digital Projection Radiographic Systems,
PACS, On Premise or On Cloud.

Cloud-based computation upon transfer to
PACS of image


It processes images within seconds of image
acquisition when deployed on Digital
Projection Radiographic Systems.

Device output in case
of positive detection

Critical Care Suite enables case prioritization
or triage through direct communication of the
Critical Care Suite notification during image
transfer to the PACS.
No markup on original image
Upon image acquisition on a Digital Projection
Radiographic System, an on-device,
technologist notification is generated 15
minutes after exam closure, indicating which
cases were prioritized by Critical Care Suite in
PACS. The technologist notification is
contextual and does not provide any
diagnostic information. The on-device,
technologist notification is not intended to
inform any clinical decision, prioritization, or
action.

Integration module notifies the
PACS/workstation for prioritization through
the worklist interface.
No markup on original image

Notification:
Recipient, timing and
means of notification

Passive notification to radiologist. Images with
suspicion of pneumothorax are flagged in
PACS/workstation.

Performance level –
timing of notification

Exams arriveon PACS with the passive
notification already incorporated, therefore
there is no delay for image transfer or
computation. The worklist prioritization
happens immediately once the exam is
received on the PACS.

Passive notification is visible upon transfer to
the PACS with a delay of about 22 seconds for
image transfer to the cloud, computation and
results transfer.

Performance level –
accuracy of
classification

ROC AUC > 0.95
AUC: 0.983 (95% CI [0.9740, 0.9902]),
Specificity: 93%
Sensitivity: 93%
Stratified results on small vs. large
pneumothorax not assessed.


The timing of the processing and prioritization is well within the clinical
operational expectations of standard chest radiographic exam and its
reading by radiologists.
According to Gaskin, Cree M., et al. "Impact of a Reading Priority Scoring
System on the Prioritization of Examination Interpretations." American
Journal of Roentgenology 206.5 (2016): 1031‐1039 and Rachh, Pratik, et
al. "Reducing STAT Portable Chest Radiograph Turnaround Times: A Pilot
Study." Current problems in diagnostic radiology (2017), the estimated
average Report Turnaround Time for non‐prioritized or ineffectively
prioritized exams is between 7.23 hours and 8.67 hours.
Incorporating the Critical Care Suite passive notification to help
radiologists prioritize their exam reads would drastically reduce this
turnaround time for the cases that have been flagged by Critical Care
Suite as compared to standard of care (First‐In, First‐Out).
Summary of Clinical Evaluation:
Critical Care Suite was evaluated on a dataset of 804 frontal chest X‐rays
collected in North America and representative of the intended
population. The algorithm prediction is compared to the ground truth
established by 3 independent US‐board certified radiologists. The
algorithm ROC AUC meets the performance requirement of FDA product
code QFM (AUC>95%): AUC=96% (95% CI [94.9% ‐ 97.2%]) (PTX present:
N=376; PTX absent: N=428). Stratified analyses showed consistent
performance across image view (AP/PA), system manufacturer (GE/non‐
GE) and data sources.
Critical Care Suite performs at high specificity 93.5% (95% CI [91.1% ‐
95.8%]) and high sensitivity 84.3% (95% CI [80.6% – 88.0%]). Stratified
analysis by pneumothorax size shows that nearly all large
pneumothoraces are detected (96.3% with 95% CI [93.3% ‐ 99.2%])
while 3 out 4 small pneumothoraces are detected (75% with 95% CI
[69.2% ‐ 80.8%]) with limited false notifications thanks to the high
specificity.

Critical Care Suite and HealthPNX are software devices intended to aid in
triage and prioritization of radiological images. Both devices use artificial
intelligence algorithms to identify suspicious findings suggestive of
pneumothorax in chest X‐ray images. Both devices are intended to


(Predicate Device, K133640)
(Proposed Device)

Utilizes a dedicated Deep Neural
Network (DNN) which is trained 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

The characterization of the
scanned object using
information obtained from
extensive phantom and clinical
data

Utilizes a trained Deep Neural Network
(DNN) which models the scanned
object using information obtained from
extensive phantom and clinical data

Select recon type and strength
(percentage)

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

between the predicate device and the proposed device:


Automated labeling with
manual editing capability

geometric measurement
tools (distance line,
polyline, marker, arrow,
angle), HU measurement
tools (Pixel lens, ROI
circle, ROI polygonal, ROI
freehand, VOl sphere)

Access to all standard
Volume Viewer tools for
measuring distances, areas,
Hounsfield unit values and
annotating within the images

Multiplanar reconstruction
(MPR) thin/thick,
maximum intensity
projection (MIP) thin/thick,
inverted MIP thin/thick,
volume rendering technique
(VRT)

Multiplanar Reconstruction
(MPR) displays of axial,
sagittal, coronal, oblique, x-
section and curved views
which can be displayed in
thin/thick, Average,
Maximum Intensity
Projection (MIP), Minimum
intensity Projection (MinIP),
Volume Rendering (VR)
modes.


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

Brian R. Zielski
Regulatory Affairs Leader
GE Healthcare
Phone: 262-521-6609

James McMahon
Senior Director, Regulatory Affairs
GE Healthcare
Phone: 508-382-2858

Common/Usual Name:
Magnetic Resonance Diagnostic Device

Magnetic Resonance Diagnostic Device per 21 CFR
892.1000

Predicate Device(s):
SIGNA Premier (K171128)

SIGNA Premier is a whole body magnetic resonance
scanner designed to support high resolution, high signal-
to-noise ratio, and short scan times, and is designed for
improved patient comfort and workflow. The system
features a 3.0T superconducting magnet with a 70cm bore
size and can image in the sagittal, coronal, axial, oblique,
and double oblique planes, using various pulse sequences,
imaging techniques and reconstruction algorithms. The
system is designed to conform to NEMA DICOM


standards (Digital Imaging and Communications in
Medicine).
The modifications to this system include the AIRx
software features, which allows users the flexibility to
automate and standardize a number of connected steps
required for an MRI examination of the brain.

The SIGNA Premier 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
entire body, including, but not limited to, head, neck,
TMJ, spine, breast, heart, abdomen, pelvis, joints,
prostate, blood vessels, and musculoskeletal regions of the
body. Depending on the region of interest being imaged,
contrast agents may be used.
The images produced by the SIGNA Premier system
reflect 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 indications for use statement and intended use are
identical to the predicate device, in accordance with the
FDA’s guidance document “The 510(k) Program:
Evaluating Substantial Equivalence in Premarket
Notifications [510(k)]”, dated 28 July 2014.

The SIGNA Premier with the proposed software feature
employ the same fundamental technology as the predicate
device.
The SIGNA Premier has been modified to include the
AIRx feature, which automates and standardizes a number
of connected steps required for an MRI examination of the
brain. AIRx was developed using deep learning
algorithms.


These technological differences do not raise any different
questions regarding safety and effectiveness. Both devices
must allow for an effective method to setup an appropriate
scan prescription. The performance data described in this
submission include results of both bench testing and
clinical testing that show the performance of the SIGNA
Premier compared to the predicate device.

Determination of
Substantial Equivalence:

Summary of Non-Clinical Tests:
The modifications to SIGNA Premier include the AIRx
software only feature and complies with the following
voluntary standards:
(cid:120) IEC 62304
(cid:120) ANSI/AAMI 60601-1
(cid:120) IEC 60601-2-33
The following quality assurance measures were applied to
the development of the subject device, as they were for
the predicate device:
(cid:120) Risk Analysis
(cid:120) Requirements Reviews
(cid:120) Design Reviews
(cid:120) Integration testing (System verification)
(cid:120) Performance testing (Verification)
(cid:120) Simulated use testing (Validation)
The non-clinical tests have been summarized in the
verification and validation testing for AIRx. The testing
was completed with passing results per pass/fail criteria
defined in the test cases. This supports substantial
equivalence to its predicate because it was also developed
under quality assurance Design Controls. In addition, the
software complies with the same applicable Standards.
Summary of Clinical Tests:
Internal scans were conducted as part of validation for
AIRx workflow to confirm the productivity and
consistency benefits of the proposed feature. The AIRx
feature is a pre-scan algorithm, and the MR System


maintains the same imaging performance results as its
predicate device (K171128).

The SIGNA Premier with the modified software feature
has the same intended use as the predicate. This 510(k)
submission includes information on the technological
characteristics of the proposed software feature, as well as
performance data demonstrating that the feature is as safe
and effective as the predicate, and does not raise different
questions of safety and effectiveness.
In conclusion, GE Healthcare considers the SIGNA
Premier to be as safe, as effective, and performance is
substantially equivalent to the predicate devices.


Subject Device
Predicate Device
Comparison Results

Siemens
syngo.CT Cardiac Function
(K123585)

Modified
subject device: deep learning-based algorithm
predicate device:model-based segmentation
algorithm

Color overlay of MPR and
VRT with evaluation results

Automatic detection of coronary
vessels and coronary calcium

Modified
subject device: deep learning-based
algorithm, 9 AHA positions
predicate device:model-based segmentation
algorithm, aortic root plane

Aorta diameter measurements
Aorta diameter measurements
Same

New
measurements are compared with results from
a standard population, deviations are
signalized to the user

Color overlay of MPR and
VRTwith evaluation results

Table 1: Predicate Device Comparable Properties


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

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

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

Table 2: Voluntary Conformance Standards


Feature
Subject Device
Predicate Device
Comparison Results

Siemens
syngo.CT Pulmo 3D
(K123540, clearance
date 8/29/2013)

Modified
subject device: segmentation of
complete lungs
predicate device: dedicated
algorithm for segmentation of
both lungs

Segmentation of lung
thirds, lung core/peel,
lung lobes

Modified
subject device: deep learning-
based algorithm for long lobes
segmentation
predicate device: Model-based
segmentation algorithm

Calculation and
visualization of lung
tissue below -950 HU

Calculation and
visualization of lung
tissue below threshold

Modified
Subject device: fixed threshold
for segmentation
Predicate device: Configurable
threshold for segmentation


Visualization of
segmentation and
parenchyma
results

Color overlay of MPR
and VRT with evaluation
results

Interface to syngo.CT
LungCAD (K143196) is
supported

Segmentation of lesions
of the lung, liver, and
lymph nodes

Modified
subject device: segmentation of
lung lesions and localization of
found lesion to lung lobe
predicate device: segmentation
of lesions of lung, liver, lymph
nodes, and general anatomies

Visualization of
lesion
segmentation
results


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


Feature
Subject Device
Predicate Device
Comparison Results

Equivalent. The subject device
supports a new version of software
that is deployable on the Siemens
cloud infrastructure

Extendable via
additional post-
processing
extensions

Extendable via
additional post-
processing tools

Equivalent. The subject device
has been modified to support
extensions that can perform
automated post-processing using
artificial intelligence algorithms

Standard
visualization tools
(window levels,
MPR, MIP, VRT)

In the Distribution
step it is shown to
which DICOM nodes
a series will be sent
when saving the
case, or to which
node a series has
already been sent.
The user can select
(or deselect)
whether a series will
be sent to any
DICOM node or to a
subset of nodes.

Sending of DICOM
data to DICOM
nodes possible in
the export
functionality

Equivalent. The subject device
has been modified to support
transfer to a preconfigured DICOM
node

Equivalent. The subject device
has been modified to provide only
basic functionality for confirmation
of processed results

Equivalent. The subject device
has been modified to expose
configuration options of existent
extensions

Equivalent. The subject device
has been modified to only store
meta data

Communication
DICOM compatible
DICOM compatible
Same


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

Medical devices - Part 1: Application of
usability engineering to medical devices
[Including CORRIGENDUM 1 (2016)]


RTHawk (ver 2.3.2)
HeartVIsta Cardiac Package


RTHawk operates compatible MR scanners within the safety parameters listed below:


Medical electrical equipment - Part 2-33: Particular
requirements for the basic safety and essential performance of
magnetic resonance equipment for medical diagnostic
(radiology).

Determination of Signal-to-Noise Ratio (SNR) in Diagnostic
Magnetic Resonance Imaging

Determination of Image Uniformity in Diagnostic Magnetic
Resonance Images

Acoustic Noise Measurement Procedure for Diagnostic
Magnetic Resonance Imaging Devices

Characterization of the Specific Absorption Rate (SAR) for
Magnetic Resonance Imaging Systems

Digital Imaging And Communications In Medicine (DICOM)
Set.

the table below, as applicable to device features and components:


Medical Devices - Application Of Risk Management To
Medical Devices

(Consolidated Text) Medical Electrical Equipment - Part 1:
General Requirements For Basic Safety And Essential
Performance (IEC 60601-1:2005, Mod). Section 14
Programmable Electrical Medical Systems (PEMS)


Predicate Device
K170090
RTHawk (ver 2.3.2)
HeartVista Cardiac Package

Modified Device
K183274
RTHawk (ver 2.5.1)
HeartVista Cardiac Package

RTHawk is an accessory to 1.5T
and 3.0T whole-body magnetic
resonance diagnostic devices
(MRDD or MR). It is intended to
operate alongside, and in parallel
with, the existing MR console to
acquire traditional, real-time, and
accelerated images. The
HeartVista Cardiac Package is a
collection of RTHawk Apps
designed to acquire, reconstruct
and display cardiovascular MR
(CMR) images.
RTHawk produces static and
dynamic transverse, coronal,
sagittal, and oblique
cross-sectional images that display
the internal structures and/or
functions of the entire body. The
images produced reflect the spatial
distribution of nuclei exhibiting
magnetic resonance. The magnetic
resonance properties that
determine image appearance are
proton density, spin-lattice
relaxation time (T1), spin-spin
relaxation time (T2) and flow. When
interpreted by a trained physician,
these images provide information


that may assist in the determination
of a diagnosis.
RTHawk is intended for use as an
accessory to the following MRI
systems:
Manufacturer: GE Healthcare
(GEHC)
Field Strength: 1.5T and 3.0T
Scanner Software Versions: 12, 15,
16, 23, 24, 25, 26

Transverse, Coronal, Sagittal,
Oblique, Double Oblique

Ventricular Function
Free-Breathing and Breath-Held
Free-Breathing and Breath-Held

MDE
Free-Breathing and Breath-Held
Free-Breathing and Breath-Held

Flow Imaging
Real-Time
Real-Time, Multi-Slice, and 4D


Summary of Comparison to Predicate Device


ContaCT is a notification-only, parallel workflow
tool for use by hospital networks and radiologists
to identify and communicate images of specific
patients to a radiologist, 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 radiologist 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 neurovascular
radiologist that a suspected large vessel occlusion
has been identified and recommends review of
those images. Images can be previewed through a
mobile application.
Images that are previewed through the mobile
application are compressed and are for
informational purposes only and not intended for
diagnostic use beyond notification. Notified
radiologists 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.

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

Similarities
• Used by radiologists
• Identifies specific
patients
• Operates in parallel
to standard of care
workflow
• Uses artificial
intelligence to
analyze images
• Looking for findings
suggestive of a pre-
specified clinical
condition
• Not intended for
diagnostic use
• Radiologists are
responsible for
viewing images on a
diagnostic viewer
• 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
Noted difference:
cmTriage notification
is passive vs. proactive
and cmTriage codes
are accessed by
radiologist through
PACS worklist and
used for prioritization.

The device provides triage or notification that is
informed by machine learning, artificial
intelligence or other image analysis algorithms

The device operates on radiological images of the
human body.

Anatomical Site
Head
Breast
Different anatomic site

Where Used
Hospital or Clinic
Hospital or Clinic
Same

User Population
Radiologist
Radiologist
Same

Software
Device is software only
Device is software only
Same

Communicates images of patients to a radiologist.

Does not communicate images of patients.
cmTriage passively notifies the radiologist via the
PACS worklist, whereas ContaCT notifies a pre-
identified specialist via direct message.

Noted difference: No
images are
communicated from
cmTriage to
radiologist. Only
cmTriage codes are
returned for viewing
within the PACS
worklist.


Device Classification Name
system, image processing, radiological

Zetta Medical Technologies, LLC.
1313 Ensell Road
Lake Zurich, IL 60047

The ClariCT.AI software device is substantially equivalent to K160852:


Item
Subject Device – ClariCT.AI
Predicate- ZIA

ClariCT.AI is intended for
networking, communication,
processing and enhancement
of CT images in DICOM
format.

ZIA image enhancement system is
an image processing software that
can be used for reducing noise in
CT images. Enhanced images will
be uploaded back to host/PACS
systems and exist in conjunction to
the original images. ZIA, is not
intended for mammography
applications. The device processing
is not effective for lesion, mass or
abnormalities of sizes less than 2.0
mm.

Intended User
Radiologists and Specialists
Radiologists and Specialists

Noise reduction is performed
with the use of pre-trained
deep learning models.

Regularization process at flat
regions with data fidelity constraints
at edges.

Window Operating System,
PC Hardware, CUDA
supported graphics card or
equivalent.

identical in performance to the legally marketed device.


Legal Manufacturer
Perspectum Diagnostics Ltd
Perspectum Diagnostics Ltd

Owner/Owner Operator
Perspectum Diagnostics Ltd
Perspectum Diagnostics Ltd


Comparison of subject and Predicate Device

Characteristic
LMSv3 (Subject device)
LMSv2 (Predicate device)

“LiverMultiScan (LMSv3) is indicated for use as a
magnetic resonance diagnostic device software
application for non-invasive liver evaluation that
enables the generation, display and review of 2D
magnetic resonance medical image data and
pixel maps for MR relaxation times.
LiverMultiScan (LMSv3) is designed to utilize
DICOM 3.0 compliant magnetic resonance image
datasets, acquired from compatible MR Systems,
to display the internal structure of the abdomen
including the liver. Other physical parameters
derived from the images may also be produced.
LiverMultiScan (LMSv3) provides a number of
tools, such as automated liver segmentation and
region of interest (ROI) placements, to be used
for the assessment of selected regions of an
image. Quantitative assessment of selected
regions includes the determination of
triglyceride fat fraction in the liver (PDFF), T2*
and iron-corrected T1 (cT1) measurements. PDFF
may optionally be computed using the LMS
IDEAL or three-point Dixon methodology.
These images and the physical parameters
derived from the images, when interpreted by a
trained clinician, yield information that may
assist in diagnosis.”

“LiverMultiScan is indicated for use
as a magnetic resonance diagnostic device
software application for non-invasive liver
evaluation that enables the generation, display
and review of 2D magnetic resonance medical
image data and pixel maps for MR relaxation
times.
LiverMultiScan is designed to utilize DICOM 3.0
compliant magnetic resonance image datasets,
acquired from compatible MR Systems, to
display the internal structure of the abdomen
including the liver. Other physical parameters
derived from the images may also be produced.
LiverMultiScan provides a number
of quantification tools, such as Region of Interest
(ROI) placements, to be used for the assessment
of regions of an image to quantify liver tissue
characteristics, including the determination
of triglyceride fat fraction in the liver, T2* and
iron-corrected T1 measurements.
These images and the physical parameters
derived from the images, when interpreted by a
trained clinician, yield information that may
assist in diagnosis.”

Patients suitable to undergo an MRI scan and not
contra-indicated for MRI.

Device User
Trained PD operator
Trained PD operator
Trained PD operator

Report User
An interpreting clinician or healthcare
An interpreting clinician or healthcare

Installation of LMSv3 is controlled and installed
on general purpose workstations at PD’s image
analysis centre

Installation of LMsv2 is controlled and installed
on general purpose workstations at PD’s image
analysis centre

LMSv3 is a standalone software device that’s

LMSv2 is a standalone software device that’s

intended to be installed on general use
intended to be installed on general use

workstations at PD’s image analysis centre. The

intended device users will log on to the


Comparison of subject and Predicate Device

Characteristic
LMSv3 (Subject device)
LMSv2 (Predicate device)

workstations, access the device, and use the

device on general-use HD monitors.
device on general-use HD monitors.

LMSv3 is a post-processing software, the

LMSv2 is a post-processing software, the

intended device users are trained internal PD

The end-users for the output from the device,

The end-users for the output, the pdf report, are

the pdf report, are clinicians who receive and

clinicians who receive and interpret LMSv2

Anatomical
Abdomen, Liver
Abdomen, Liver
Abdomen, Liver
Abdomen, Liver

Software only application. The device, a
standalone software application, does not
deliver, monitor or depend on energy delivered
to or from patients.

Standalone software application to facilitate the
import and visualization of MR data sets
encompassing the abdomen, including the liver
with functionality independent of the MRI
equipment vendor.
Software application intended to display and
visualize 2D multi-slice, spin-echo MR data sets
encompassing the abdomen. The user may
process, and review DICOM 3.0 compliant
datasets within the system.

Standalone software application to facilitate the
import and visualization of MR data sets
encompassing the abdomen, including the liver
with functionality independent of the MRI
equipment vendor.
Software application intended to display and
visualize 2D multi-slice, spin-echo MR data sets
encompassing the abdomen. The user may
process, and review DICOM 3.0 compliant
datasets within the system and/or across
computer networks.

Allows for the visualisation via parametric maps
and quantification of metrics (cT1, T2* and PDFF)
from liver tissue and exportation of results &
images to a deliverable pdf report*.
LMSv3 allows for:
cT1
• ROI placed method on the cT1 map with IQR
and median metrics from the placed ROI’s
potentially across multiple acquired slices.
• Full segmentation of the outer liver contour
and liver vasculature of the cT1 parametric
map. IQR and median metrics are reported
from the segmentation.
T2*
• ROI placed method on the T2* map with
IQR and median metrics from the placed
ROI’s potentially across multiple acquired

Allows for the visualisation via parametric maps
and quantification of metrics (cT1, T2* and PDFF)
from liver tissue and exportation of results &
images to a deliverable pdf report.
LMSv2 allows for:
cT1
• ROI placed method on the cT1 map with IQR
and median metrics from the placed ROI’s
potentially across multiple acquired slices.
T2*
• ROI placed method on the T2* map with
IQR and median metrics from the placed


Comparison of subject and Predicate Device

Characteristic
LMSv3 (Subject device)
LMSv2 (Predicate device)

slices T2* parametric maps are calculated
from the Gradient Multi-Echo method.
PDFF
• ROI placed method on the PDFF map with
IQR and median metrics from the placed
ROI’s potentially across multiple acquired
slices potentially across multiple acquired
slices.
• PDFF parametric maps can be calculated
using either the LMS IDEAL method [2] or
the three-point DIXON method. [1]
• Full liver segmentation of the PDFF
parametric map where IQR and median
metrics are reported from the
segmentation.

ROI’s potentially across multiple acquired
slices T2* parametric maps are calculated
from the Gradient Multi-Echo method.
PDFF
• ROI placed method on the PDFF map with
IQR and median metrics from the placed
ROI’s potentially across multiple acquired
slices potentially across multiple acquired
slices.
• PDFF parametric maps are calculated from
the three-point DIXON method. [1]

• Noise Determination Algorithms
• T1 mapping Algorithms
• T2* mapping Algorithms
• Unwrapping Phase Image Algorithms
• Creation of cT1 image Algorithms
• Water and Fat Mapping Algorithms

• Automatic Liver Segmentation Algorithms

LMSv3 uses identical algorithms cleared in LMSv2

to quantify cT1, T2* and DIXON PDFF using ROI’s.

T1, iron-corrected T1 (cT1) and T2* mapping.

Utilizes MR images that exploit the difference in
resonance frequencies between hydrogen nuclei
in water and triglyceride fat using either LMS
IDEAL method or three-point DIXON method.

Utilizes MR images that exploit the difference in
resonance frequencies between hydrogen nuclei
in water and triglyceride fat using the three-
point DIXON method.


LMSv3 supports automatic multi-slice full liver
segmentation of the cT1 and PDFF parametric
map. Use of this functionality is at the discretion
of the operator instead or in combination with
the ROI based method.
The cT1 segmented liver is presented in colour
level window, while the rest of the cT1 image is
presented in greyscale level window with ducts
and liver vasculature excluded from the
segmented volume.

Does not support whole liver segmentation. See
first reference device below, LiverLab.

Median and interquartile range measurements
created from a cross sectional slice of liver
tissue. For each parametric map, statistics from
multiple Regions of Interest (ROIs) – potentially
placed across multiple slices – are summarised.
Also supports the display of ‘Live’ ROI statistics
when moving the ROI across the parametric
map.

Iron corrected T1 (cT1), T2* and triglyceride fat
(i.e. DIXON or IDEAL Proton Density Fat Fraction
(PDFF)) parametric maps are supported.
PDFF parametric maps are calculated with either
MAGNITUDE ONLY-IDEAL, when the data is
received from GE and Phillips scanners, and
COMPLEX-IDEAL for Siemens. When analysing
COPLEX-IDEAL data a field map is also available
during analysis. PDFF may also be calculated
using the three-point DIXON method.

Iron corrected T1 (cT1), T2* and triglyceride fat
(i.e. DIXON Proton Density Fat Fraction (PDFF))
parametric maps are supported.

Iron corrected T1 (cT1), T2* and triglyceride fat
(also known as Proton Density Fat Fraction
(PDFF)) parametric maps are supported.
Iron corrected T1 (cT1) displayed using LMSv3
colourmap, designed to have maximum contrast
on liver parenchymal tissue.

Iron corrected T1 (cT1), T2* and triglyceride fat
(also known as Proton Density Fat Fraction
(PDFF)) parametric maps are supported.
Iron corrected T1 (cT1) displayed using LMSv2
colourmap, designed to have maximum contrast
on liver parenchymal tissue.

DICOM 3.0 compliant MR data from supported
MRI scanners.

Quantified metrics from liver tissue and image
analysis collated in a deliverable pdf report.
Histogram of segmented area and proportion of
PDFF intensities are included in the final report
to give a better understanding on the
distribution of PDFF intensities.

Quantified metrics from liver tissue and images
analysis collated in a deliverable pdf report.


Comparison of subject and Predicate Device

Characteristic
LMSv3 (Subject device)
LMSv2 (Predicate device)

Installation of LMSv3 is controlled and is installed

Installation of LMSv2 is controlled and is installed

on general purpose workstations at PD’s image

environment
analysis centre.
analysis centre.

LMSv3 reads in local files compliant with DICOM

LMSv2 reads in local files compliant with DICOM

Validated with phantom scans, synthetic raw
data and volunteer scans covering a range of
physiological values for cT1, T2* and PDFF.

Validated across all listed supported
manufacturers and field strengths.

Materials
Not applicable, standalone software.
Not applicable, standalone software.

Sterility
Not applicable, standalone software.
Not applicable, standalone software.

Electrical Safety
Not applicable, standalone software.
Not applicable, standalone software.

Chemical Safety
Not applicable, standalone software.
Not applicable, standalone software.

Thermal Safety
Not applicable, standalone software.
Not applicable, standalone software.


Phantom Metrics
Repeatability
Reproducibility

95% CI Limits of Agreement
95% CI Limits of Agreement

• LMSv3 measurements of T1, T2* and PDFF are reproducible between different scanners


Volunteer Metrics
Repeatability
Reproducibility

DIXON PDFF (Segmentation)
-1.20 to 1.06%
-3.14 to 0.88%

IDEAL PDFF (Segmentation)
-1.83 to 1.28 %
-1.74 to 1.21

• LMSv3 measurements of cT1, T2* and PDFF under the ‘worst case’ variability conditions are highly reproducible


Volunteer Metrics
Intra-Operator
Inter-Operator

DIXON PDFF (Segmentation)
- 0.29 to 0.45%
- 0.55 to 1.22%

IDEAL PDFF (Segmentation)
- 0.16 to 0.14%
- 0.37 to 0.26%


Volunteer Metrics
Worst-Case Variability

DIXON PDFF (Segmentation)
-2.72 to 1.24%

IDEAL PDFF (Segmentation)
-1.92 to 1.35%

IDEAL PDFF (Segmentation) - 0.16 to 0.14% - 0.37 to 0.26%


Results (Range)
95% CI Limits of Agreement

device when measuring PDFF<30%, and within 2% when measuring PDFF>30%.


values within 2ms. There is negligible difference in the measurement of PDFF between LMSv3 and the predicate.