Years experience
Breast imaging
Breast MRI


Identified Risks to Health
Mitigation Measures

Incorrect lesion(s) characterization
leading to false positive results may
result in incorrect patient management
with possible adverse effects such as
unnecessary treatment, unnecessary
additional medical imaging and/or
unnecessary additional diagnostic
workup such as biopsy.

Certain design verification and
validation activities identified in special
control (1)
Certain labeling information identified in
special control (2)

Incorrect lesion(s) characterization
leading to false negative results may
lead to complications, including
incorrect diagnosis and delay in disease
management.

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

L. Identified Risks to Health and Mitigation Measures


The study was enriched and individual readers in practice may not
experience a significant improvement in diagnosing breast cancer
lesions.

Yes, the probable benefits outweigh the probable risks, given the
combination of required general controls and the special controls
established for this device. The Special Controls will sufficiently assist
in managing risks associated with incorrect lesion(s) characterization,
application of the device results to the wrong patient population,
analysis of incompatible images, and/or device failure by insuring
proper performance and use of the device.
By providing a systematic automated analysis of a multiple factors in
reviewing breast MRI lesions, the device may marginally improve
diagnostic performance and consistency in evaluating a multitude of
clinical factors. The QuantX analytics calculate the morphological and
enhancement characteristics of a breast lesion the QuantX package
uses pattern recognition techniques and displays similar lesions from
a fixed database of biopsy-proven non-cancer and cancer. A user will
be able to view and interpret the lesion characteristics and similar
cases during their diagnosis of a patient’s breast lesions.
By demonstrating an ability to assist users in the classification of
breast MRI lesions as BIRADS 2, or 3 or 4a, the device may provide
improved diagnostic accuracy as assessed by an improvement in
AUC. In particular, secondary analyses suggest improved sensitivity
based on BI-RADS 3 as the cut-point without decreased specificity for
some readers.
The device provides information that may be useful in the
characterization of breast abnormalities, but does not replace the
physician. The physician determines the diagnosis and the information
provided by the device is unlikely to decrease diagnostic performance
of the user. Not all users may experience a substantial improvement in
diagnostic performance based on the use of the device. However, the
device is not likely to lead to a substantial decline in reader
performance either.
Therefore, given the available information concerning the benefits,
risks, and supporting data; the probable benefits outweigh the
probable risks, given the combination of required general controls and
special controls established for this device.

Conclusions
Do the probable
benefits outweigh
the probable risks?


Time to Notification of
Specialist for LVO cases (mins)


generate a standard of care Time to Notification of Specialist.


Failure to prioritize images for
review with positive findings may
result in incon ect and/or delayed
patient management

Ce1iain design verification and validation
activities identified in special control (1)
Ce1iain labeling info1mation identified in
special control (2)

Positive notifications may result in
deprioritization of review of
images from other patients.

The device could be misused to
analyze images from an unintended
patient population or on images
acquired with incompatible
imaging hai·dwai·e or incompatible
image acquisition pai·ameters,
leading to inappropriate
notifications being displayed to the
user.

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

The triage and notification outputs
of the device ai·e inappropriately
used for primary interpretation or


In Viz.Al's study the average and median CTA -to-notification times were 58.72
minutes and 51.50 minutes, respectively, for the Standard of Care (two-sided
95% confidence interval for the mean: [46.21, 71 .23]. The average and median
CTA-to-notification times were 7.32 minutes and 5.60 minutes, respectively, for
ContaCT (two-sided 95% confidence interval for the mean: [5.51, 9.131). This is
also lower than the average time to notification of 66 minutes reported in
literature for LVO's diagnosed with CT Angiogram. The notification is informed
by the software algorithm with a sensitivity and specificity are 87.8% (81.2% -
92.5%) and 89.6% (83.7% - 93.9%), respectively.
The clinical benefit is that the device identifies patients who may benefit from
rapid intervention by a neurovascular specialist. The clinical benefit is that a
patient may be eligible for use of mechanical thrombectomy and/or tPA
administration. By using one or both of these techniques, a substantial relative
volume of brain may be able to be saved by timely intervention.
From an overall US public health perspective, by treating ischemic stroke of
large vessels more aggressively, as is now done for acute coronary artery
occlusion, the resulting amount of disability from ischemic stroke, which
remains a major cause of US disability in both men and women can potentially
be significantly decreased.

There are no major risks for the device because the device operates in parallel
to the current usual standard of care.
Minor risks include:
• Failure to prioritize images for review with positive findings may result
in incorrect and/or delayed patient management.
• Positive notifications may result in deprioritisation of review of images
from other patients.
• The device could be misused to analyse images from an unintended
patient population or on images acquired with incompatible imaging
hardware or incompatible image acquisition parameters, leading to
inappropriate notifications being displayed to the user.
• Device failure could lead to the absence of results, delay of results or
incorrect results, which could likewise lead to inaccurate patient
assessment.
• The triage and notification outputs of the device are inappropriately
used for primary interpretation or as an adjunct for diagnosis outside
the intended use of the device.


The device only notifies the neurovascular specialist. Beyond that it is up the
regional healthcare delivery system to get the patient the neurovascular
specialist in the neurovascular interventional suite/operating room.
If adequately treated in time the patient will have no residual neurological
deficit. In some cases there may be a small residual neurological deficit. If the
disease is untreated, there may be loss of speech, recognition of words,
movement of the arms and/or legs, normal bowel and bladder control, or other
neurologic functions resulting potentially in long term disability.

Conclusions
Do the probable
benefits outweigh the
probable risks?

Yes. The benefit of ContaCT, namely, early identification and notification of a
specialist significantly outweighs the minimal risk of a small amount of the
specialists time needed to review and disregard a false positive. In the case of
a false negative, the standard of care workflow prevails, so there is no risk
compared to standard of care for the patient. In general, there is no direct risk
to the patient as this is a notification only, software only device. There are no
significant risks which have not been mitigated via clinical testing and labelling.
Therefore, given the available information concerning the benefits, risks, and
supporting data, the probable benefits for the device outweighs the probable
risks, given the combination of general controls and special controls established
for this device.


and 95% with Wilson's Confidence Intervals:


Subgroup
Performance Metric (90% Wilson's Cl)

View Characteristic Sensitivity Specificity PPV NPV


Modality Sensitivity Specificity PPV NPV


OsteoDetect-aided and OsteoDetect-unaided reads were repo1ied as follows:


General controls and special controls
(1) and (2).

Device misuse (analyzing images from
unintended patient population or ofan
unintended anatomical site; or images
acquired with an unintended modality,
incompatible imaging hai·dwai·e, or
incompatible image acquisition
parameters) resulting in lower device
perfo1mance (inappropriate
detection/diagnosis info1m ation being
displayed to the end user)

Device failure could lead to absence of
results, delay ofresults, or inco1Tect
results, which can lead to delayed or
inaccurate patient dia!lllosis

L. Identified Risks to Health and Identified Mitigations


The clinical MRMC study demonstrated a statistically significant
improvement in reader perfo1mance in detecting distal radius fracture in
adult patients (as measured by the prima1y endpoint of the ROC Area
Under the Curve) when aided with OsteoDetect as compared to
perfonnance at the same task without OsteoDetect, according to clinical
standard ofcare.
AUCaided -AUCunaided = 0.889 - 0.840= 0.049 (two sided 95%
confidence level [0.019,0.080])
OsteoDetect-aided read perfo1mance also showed statistically significant
improvement as measured by sensitivity, specificity, PPV, and NPV as
compared with the unaided read perfo1mance. Specifically, Imagen's
study demonstrated a device-aided sensitivity of 80.3% (two sided 95%
confidence interval for the mean: [78.5%,81.9%]) and device-aided
specificity of91.4% (two sided 95% confidence interval for the mean:
[90.3%,92.4%]). By comparison, the study demonstrated non-aided
sensitivity and specificity of 74.7% [72.8%,76.5%] and 88.9%
[87.6%,90.0%], respectively.
Earlier detection ofa distal radial fracture will allow earlier intervention,
potentially allowing closed reduction and casting instead ofopen
reduction, minimizing the risk of delayed pain and post-traumatic
aithritis.

There are minimal potential risks associated with use of the device,
including:
• The device could provide false positive results, which could
contribute to the end user using this info1mation to make a false
positive diagnosis. Such a false positive diagnosis can result in
unnecessaiy patient treatment or followup.
• The device could provide false negative results, which could
contribute to the end user using this info1mation to make a false
negative diagnosis. A false negative diagnosis could lead to
delays in diagnosis and treatment of the fracture and increase the
likelihood ofnegative outcomes such as incomplete fracture
healing.
• The device could be inisused to analyze images from an
unintended patient population or on images acquired with


incompatible imaging hardware or incompatible image
acquisition parameters, leading to inappropriate information
regarding the presence/location ofa fracture being provided to
the end user.
• The device could fail and lead to absence of results, delay of
results, or inco1Tect results, which can lead to delayed or
inaccurate patient diagnosis
However, based on the perfonnance data and the application ofgeneral
controls and special controls established for this device type, use ofthis
device is unlikely to increase the rate offalse negative or false positive
diagnoses of distal radius fracture as compared with the cmTent clinical
standard ofpractice. Fmt her, possible misuse ofthe device does not
present additional risks compared with the misuse ofother types of
radiological image processing devices.

CmTently, injuries to the hand and wrist account for approximately 20%
ofvisits to the emergency depaitment, with a total ofapproximately 3.5
million hand and wrist injuries noted in 2009, for an incidence of 1130
injuries per 100,000 persons per yeai·. (Hand (NY) 2012; 7:18-22) By
detecting a potentially occult distal radial fracture earlier, pain, post
traumatic aithritis, and possible disability are alleviated, resulting in a
potential significant improvement in US public health.
This software tool brings the expe1tise ofmusculoskeletal radiologists
and 01thopaedic surgeons specializing in hand surge1y to emergency
medicine physicians and physician assistants, fainily practice physicians,
and internal medicine physicians. Therefore, subspecialty expertise is
potentially available to emergency rooms across the countiy with the use
ofthis software device.

Conclusions
Do the probable
benefits outweigh
the probable risks?

The benefited population would include adult patients with clinically
suspected distal radius fracture. This softwai·e potentially brings
subspecialty expe1tise ofmusculoskeletal radiologists and 01thopaedic
surgeons specializing in hand and wrist surge1y to physicians and
physician assistants working in emergency rooms across the countiy.
The underlying statistics as discussed above justify that the perfo1m ance
ofthe device has been clinically validated in a fully crossed design. The
4 types of clinical providers (emergency medicine physicians, emergency
medicine physician assistants, family medicine physicians, and internal
medicine physicians) most likely to staff emergency rooms were
separately evaluated, and all showed improvement in the detection ofa
distal radial fracture aided by the device. Given that the standai·d ofcare
in 2018 is to cast and have a follow-up X-ray in 10-14 days or perfo1m
an MRI in cases where a distal radial fracture is clinically suspected in


% of Scans of Sufficit>nt
Quality
(MRMC CI)

Qualitative Visual Assessment of Left Ventricular Size

Qualitative Visual Assessment of Global Left Ventricular
Ftmction

Qualitative Visual Assessment of Right Ventricular Size

Qualitative Visual Assessment of Non-Trivial Pericardia!
Effusion

assessments in the following proportion of study exams conducted:


% of Scans of Sufficient
Quality
(MRMC 95% CI)

Qualitative visual assessment of inferior vena cava size

Qualitative visual assessment of right ventricular ftmction

Qualitative visual assessment of left atrial size

Qualitative visual assessment of ao1t ic valve

Qualitative visual assessment of mitral valve

Qualitative visual assessment of tricuspid valve


% of Clips of Diagnostic Quality
[MRMCCI]

views in the following proportion of study exams conducted:


Device Error – Failure to provide guidance on
acquiring diagnostic-quality images or signals,
leading to delay, prolonged examination, or
additional unnecessary procedures, due to:
 Algorithm failure
 Hardware or software failure

 Design verification and validation
 Labeling

User Error – Operator failure to follow the
guidance provided by the device to acquire
diagnostic-quality images or signals, leading to
delay, prolonged examination, or additional
unnecessary procedures, due to human error


 Echocardiography is a highly valuable method for assessment of
various structural and functional characteristics of the heart.
Additionally, with the development of point-of-care ultrasound
imaging, echocardiography at the bedside could provide a valuable
first line of cardiac assessment in settings outside of a traditional
cardiology department, or hospitals. Caption Guidance is a tool to
fulfill this important clinical need.
 Echocardiography is highly operator-dependent, and the training for
echocardiography takes a significant amount of time, leading to a
shortage of skilled cardiac sonographers. Caption Guidance
provides a tool to enable non-cardiac sonographers to acquire
standard echocardiography images that can be later reviewed by an
expert cardiac healthcare professional. The pivotal study for non-
users of cardiac ultrasound was significant and clinically
meaningful.
 Echocardiography is a highly operator-dependent imaging
modality, and there is variation of echocardiograms’ quality.
Caption Guidance is a tool to address the variability of
echocardiograms’ quality by providing a quantitative image quality
metric.

Low-quality images from software/algorithm error, hardware error, or
user error, leading to additional unnecessary examinations, and/or delay
of diagnosis.


Patient Demographics and
Training Dataset

Table 1. Distribution of Training Dataset


Study Population Exams
Discrimination:
Calibration:

Sub-group Analyses (Total Study Population)

Total Study Population and for Subgroup Analyses


Sub-group Analyses (Excluding Current Cancers)

Table 4. Subgroup Analysis for the Total Study Population Excluding Patients with Current Cancer


Table 5. Decile-level Statistics for the Total Study Population


Table 6. Decile-level Statistics for the Total Study Population Excluding Patients with Current Cancer


Device provides inaccurate risk discrimination
and/or calibration contributing to:
• Falsely high risk output, leading to
patients receiving unnecessary
additional imaging or preventive risk
reduction measures
• Falsely low risk output, leading to
patients not receiving additional
imaging or preventive risk reduction
measures

Clinical performance testing
Software verification, validation, and hazard
analysis
Labeling
Postmarket monitoring plan

Inconsistent device output due to differences in
acquisition, equipment settings, or other
factors affecting image selection or quality

Clinical performance testing
Software verification, validation and hazard
analysis
Labeling
Postmarket monitoring plan

User misinterpretation of device result(s)
contributing to:
• Inappropriate categorization of patient
risk resulting in erroneous patient
management decisions related to
additional imaging or preventive risk
reduction measures
• Overreliance on device output
Patient misinterpretation of device result(s)
contributing to
• Considering low risk to be negligible
which may contribute to not receiving
standard-of-care screening or
preventive risk reduction measures


Inappropriate patient management due to
inaccurate prediction of actual delivery date,
whether significantly early or late

Software verification, validation, and hazard

whether significantly early or late
analysis

type are summarized in the following table:


Inappropriate patient management resulting
from inconsistent device output due to
differences in acquisitions, equipment settings,
and other image input characteristics

User misinterpretation of the device’s output as

being directly reflective of the gestational age


To receive, store, transmit, post-process, display and allow
manipulation of reports and medical images from acquisition
devices, including optical or other non-DICOM format images,
DICOM images with modality type XA, US, CR, DR, SPECT, NM
and MG, and images from volumetric medical scanning devices such
as EST, CT, PET or MRI. To provide access to images derived data
and derived images via client-server software, web browser and
mobile technology.
Visualization in 2D, 3D and 4D are supported for single or multiple
datasets, or combinations thereof. Tools are provided to define and
edit paths through structures such as centerlines, which may be used
to analyze cross-sections of structures, or to provide flythrough
visualizations rendered along such a centerline. Segmentation of
regions of interest and quantitative analysis tools are provided, for
images of vasculature, pathology and morphology, including
distance, angle, volume, histogram, ratios thereof, and tracking of
quantities over time. A database is provided to track and compare
results using published comparison techniques such as RECIST and
WHO. Calcium scoring for quantification of atherosclerotic plaque
is supported.
Support is provided for digital image processing to derive metadata
or new images from input image sets, for internal use or for
forwarding to other devices using the DICOM protocol. Image
processing tools are provided to extract metadata to derive
parametric images from combinations of multiple input images, such
as temporal phases, or images co-located in space but acquired with
different imaging parameters, such as different MR pulse sequences,
or different CT image parameters (e.g. dual energy).
iNtuition is designed for use by healthcare professionals and is
intended to assist the physician in diagnosis, who is responsible for
making all final patient management decisions.
Interpretation of mammographic images or digitized film screen
images is supported only when the software is used without
compression and with an FDA-Approved monitor that offers at least
5Mpixel resolution and meets other technical specifications
reviewed and accepted by the FDA.


Brain tissue segmentation (intracranial
tissue volume GM+WM, CSF volume, lobe
volumes, cerebellum volume). WMH
segmentation (total WMH volume).

Absolute and relative volumes
Absolute volumes

Software plugs into the AW and AW server
platforms

Following are the differences between Quantib™ Brain and the predicate device:


DMS No:
mtk1956-007-6
Rev. Date:
26th Dec 2015

Title:
Volpara Imaging Software 510(k) Summary


Predicate Device
Volpara, 1.5.1 (K152028)

“Volpara is a software application
intended for use with the raw data
from digital breast x-ray systems,
including tomosynthesis. Volpara
calculates 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. Volpara
produces adjunctive information. It
is not an interpretive or diagnostic
aid“

“Volpara is a software application
intended for use with the raw data
from digital breast x-ray systems,
including tomosynthesis. Volpara
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. Volpara 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.

Volume of Fibroglandular tissue
Volume of Breast

Substantial Equivalence Comparison Table


Volumetric Breast Density
BIRADS 4th or 5th Edition Breast
Density Category
Average thickness of dense tissue
Maximum thickness of dense
tissue (and location).
Maximum volume of dense tissue
above any 1cm2 square region
(and location).

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

Classification
21 CFR 892.2050; LLZ
21 CFR 892.2050; LLZ

Software Level of Concern
Moderate
Moderate

Title: Volpara Imaging Software 510(k) Summary


Similar; the Product
Code LLZ is not
considered as
product is not a
PACS system

Similar; the
regulation number
892.2050 is not
considered as
product is not a
PACS system

Interventional Fluoroscopic X-
Ray System

Interventional Fluoroscopic X-Ray
System / Picture Archiving and

Table 5A – Comparison of Characteristics


892.2050, PACS, is
not considered as
product is not a
PACS system

Display of combined live 2D X-
ray fluoroscopy and 3D
anatomy for image guidance
during surgery.

Display of combined live 2D X-ray
fluoroscopy and 3D anatomy for
image guidance during surgery.

3D imaging
Pre-operative
Pre-operative
Identical

Cydar EV provides image
guidance by overlaying
preoperative 3D vessel
anatomy, from a previously
acquired contrast-enhanced,
diagnostic CT scan, onto live
fluoroscopic images in order
to assist in the positioning of
guidewires, catheters and
other endovascular devices.
Cydar EV is intended to assist
fluoroscopy-guided
endovascular procedures in
the lower thorax, abdomen
and pelvis. Suitable
procedures include (but are
not limited to) endovascular
aortic aneurysm repair (AAA
and mid-distal TAA),
angioplasty, stenting and
embolization in the common
iliac, proximal external iliac
and proximal internal iliac
arteries and corresponding

VesselNavigator provides image
guidance by superimposing live
fluoroscopic images on a 3D
volume of the vessel anatomy to
assist in catheter maneuvering
and device placement.
VesselNavigator is intended to
assist in the treatment of
endovascular diseases during
procedures such as (but not
limited to) AAA, TAA, carotid
stenting, iliac interventions.

Similar; indications
for both devices
emphasize image
guidance for
fluoroscopy-guided
endovascular
procedures


veins.
Cydar EV is not intended for
use in the X-ray guided
procedures in the liver,
kidneys or pelvic organs.

Construction
Software product
Software product
Identical

Separate interventional tools
workstation

2D-3D registration is achieved
by machine vision tracking of
vertebral anatomy

2D-3D registration is achieved by
manual initialization and/or
correction followed by dead
reckoning based on
electromechanical tracking of
table and C-arm

Different; the
predicate and
subject devices use
different methods
to perform the
underlying 2D-3D
image registrations
though viewing of
the image overlay
functionality is
then performed the
same with no
additional
questions raised for
safety or efficacy

Different; targets
reflect different
registration
methods with the
image overlay
functionality being
the same with no
additional
questions raised for
safety or efficacy


Semi-automatic based on
movement of the gantry

Similar; automatic
response to patient
motion allows
registration to
continuously occur
with no additional
questions raised for
safety or efficacy

Vascular anatomy of the
chest, abdomen and pelvis.

All vascular anatomy except
coronaries and intracranial
vessels

Similar; the subject
device is restricted
to anatomy
considered
immobile with
respect to the
vertebral column
with no additional
questions raised for
safety or efficacy


Tervuursesteenweg 244
B-3001 Leuven
Belgium


Common Name
Medical Image Processing Software

Classification Name
System, Image processing, Radiological


CorTechs Labs, Inc.
4690 Executive Drive, Suite 250
San Diego, CA 92121
USA


Predicate:
syngo.CT Lung
CAD (Siemens
AG Medical
Solutions)
K143196

Predicate:
syngo.PET &
CT Oncology
(Siemens AG
Medical
Solutions)
K093621

Predicate:
ClearRead
Bone
Suppression
(Riverain
Technologies)
K092363

Subject Device:
ClearRead CT
(Riverain
Technologies)

Computer-aided
detection tool
designed to
assist
radiologists in
the detection of
solid pulmonary
nodules during
review of
MDCT
examinations of
the chest

Viewing,
manipulation,
3D-
Visualization,
and
comparison
of medical
images from
multiple
imaging
modalities.

Generating
bone
suppressed
image from
an original
PA/AP chest
radiograph

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

effectiveness of ClearRead CT for its intended use.


Attribute
CT CoPilotTM
NeuroQuant
Equivalence

CT CoPilotTM is
intended for automatic
labeling, visualization
and volumetric
quantification of
segmentable structures
from sets of CT images
of the brain. This
software is intended to
automate the current
manual process of
identifying, labeling
and quantifying
structures identified on
CT images of the brain
and to provide
automated registration
and reformatting of
data.

NeuroQuantTM is intended
for automatic labeling,
visualization and
volumetric quantification
of segmentable brain
structures from sets of MR
images. This software is
intended to automate the
current manual process of
identifying, labeling and
quantifying the volume of
segmental brain structures
identified on MR images.

Data Source
CT Scanner
MRI Scanner
Different

Reformatted, realigned
axial, coronal, and sagittal
images.

Reformatted, realigned
axial, coronal and sagittal
images.

CSF volumes, Intracranial
volume, Midline shift.

CSF volumes, Intracranial
volume, Brain structure
volumes.


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

Measurement data can be
viewed, accepted or
rejected by a physician

3D Volumetric, 2D MPR
-1mm isotropic volume
-1-5mm thick MPR

Color-coded
Segmentation
Series
(Output Data)


Submitted Device
Predicate Device
Predicate Device

Features/Characteristics
LVivo (Diacardio)
LVivoEF (Diacardio)
Syngo (Siemens)

Calculate of
Ejection Fraction
and measure
strain

Calculate Ejection
Fraction and
measure strain

Automation
Fully Automated
Fully Automated
Fully Automated

Off line EF evaluation
using DICOM clips of
any vendor

calculated for biplane EF (r=0.88, p<0001).


Software for automated analysis of
breast ultrasound lesions.

Computer aided analysis tool
intended to assist skilled physicians
in screening and diagnosis as well as
compliance with ACR BI-RADS®
ultrasound lexicon form.

Software Package
Operates on off-the-shelf hardware

Storage
Storage not supported
Storage not supported


Medtronic
Navigation,
Inc.'s
Stealth Viz
Advanced
Planning
Application with
StealthDTI
Package
(K081512)

Medtronic
Navigation,
Inc.’s
StealthStation
(K050438)

Braindreader
ApS’
NeuroReader
Medical
Image
Processing
Software
(K140828)

Allows for importing of
digital imaging sets

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

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

SIS Software Technological Characteristics Comparison Table


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

Yes; atlas-based
mapping (patient
specific);
reference
database

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

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


Clinical Application
General Specific
(Track 1 Only) (Tracks 1 & 3)
Ophthalmic Ophthalmic
Fetal Imaging & Fetal
Other Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small organ (thyroid,
scrotum, prostate,
breast)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.
(non-Card.)
Musculo-skeletal
((Conventional)
Musculo-skeletal
((Superficial)
Intravascular
Other (Urology,
Gynecology)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Fetal Echo)
Peripheral Peripheral Vessel
Vessel Other (Carotid)

Mode of Operation
B M PWD CWD Color Combined Other*
Doppler (specify)
N
N
N
N
N
N
N
N
N

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


Clinical Application
General Specific
(Track 1 Only) (Tracks 1 & 3)
Ophthalmic Ophthalmic
Fetal Imaging & Fetal
Other Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small organ (thyroid,
scrotum, prostate,
breast)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.
(non-Card.)
Musculo-skeletal
(CConventional)
Musculo-skeletal
(SSuperficial)
Intravascular
Other (Urology,
Gynecology)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Fetal Echo)
Peripheral Peripheral Vessel
Vessel Other (Carotid)

Mode of Operation
B M PWD CWD Color Combined Other*
Doppler (specify)
N
N
N
N
N


Mode of Operation
B M PWD CWD Color Combined Other*
Doppler (specify)
N
N
N
N
N
N
N


Ultrasonic Pulsed Doppler Imaging System

892.1560
Ultrasonic Pulsed Echo Imaging System
90 IYO

892.1570
Diagnostic Ultrasound Transducer
90 ITX


SONON Ultrasound Imaging System (Model: SONON 300C)

Philips Lumify Diagnostic Ultrasound System

FUJIFILM SonoSite Edge II Ultrasound System.


Non-clinical performance tests relied on this premarket notification submission for a determination of substantial

equivalence include rests which show compliance to the following standards:

Medical electrical equipment – Part 1: General requirements for basic safety

and essential performance. (Edition 3.1)


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

safety and essential performance – Collateral Standard: Electromagnetic

Capability – Requirements and tests. (4th Edition)

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)

Biological evaluation of medical devices - Part 1: Evaluation and testing

ISO 10993-1
2009
within a risk management process


51 Federal St. Suite 305
San Francisco, CA 94107

Golnaz Moeini, RAC
Director of Quality and Regulatory
Arterys Inc.

Email: quality@arterys.com
Phone: 408-504-3187


Classification Name
System, Image Processing, Radiological


The following visualization, quantification and data-reporting functionalities are provided by the

- 3D image review by means of MIP, Surface MinIP, Surface or Average

- Multi-planer reconstruction (MPR) views (axial, coronal and sagittal)

- Cardiac function quantification including stroke volume, ejection fraction, cardiac output,

end-diastolic mass and volume, end-systolic mass and volume

- Flow quantification, including net flow, forward flow, reverse flow, regurgitation

fraction, pressure gradient and primary flow direction, at user-specified locations where

contours have been created (e.g. aortic valve, pulmonary valve, mitral valve, tricuspid

The distance, area, volume, and blood flow statistics, along with user-selected, annotated images,

are displayed to the user within the software client web browser. The user has the option to save

the data for later use. The user can also send the data to the clinician database, such as PACS, for


Primary Predicate
Device:
Arterys Software v2.0
(K162513)

Secondary Predicate
Device:
Medis Imaging
QMass
(K140587)

Operating System
Linux
Linux
Not Applicable

Scanners
Both 1.5T and 3.0T
Both 1.5T and 3.0T
Not Applicable

Image input
Supports DICOM 3.0
Supports DICOM 3.0
Not Applicable

Data acquisition
protocol for flow
and volume analysis

Cardiovascular
images: multi-phase,
multi-slice and
velocity encoded
images acquired from
MRI scanners

Basic 2D, Basic 3D,
4D Flow, 2D Phase
Contrast

Image display mode
Static and cine
Static and cine
Not Applicable

Pan, zoom, rotate,
maximize/minimize,
slice scroll (view
multiple slices),
adjust window/level,
slab thickness, flow
direction and time
scroll (view multiple
phases), image ROI
placement; automated
2D ROI (with edit
functions); 2D speed
color map.

Orientation label
Yes
Yes
Not Applicable

6. Comparison of Technological Characteristics with the Predicate Devices


Yes, users can view
the DICOM
information about the
patient, study and
current image

Secondary Capture
Yes
Yes
Not Applicable

Quantitative
Analysis, Volume in
4D Flow Workflow

Quantitative
Analysis, Volume in
3D Workflow for a
short axis stack

Directional/vector
display of the blood
particle travel


Automatic selection
of the Temporal
Landmark time
points


Quantra™ is a software
application intended for use with
images acquired using digital
breast x-ray systems. Quantra
calculates volumetric breast
density as a ratio of
fibroglandular tissue and total
breast volume estimates.
Quantra also provides area
breast density as a ratio of

The Quantra™ software
application is intended for use
with mammographic images
acquired using digital breast x-
ray systems. The Quantra
software segregates breast
density into categories, which
may be useful in the reporting of
consistent BI-RADS® breast
composition categories as


fibroglandular tissue area and
total breast area estimates.
Quantra segregates breast
density into categories, which
may be useful in the reporting of
consistent BI-RADS® breast
composition categories as
mandated by certain state
regulations. The Quantra results
for each image, breast, and
subject, are intended to aid
radiologists in the assessment of
breast tissue composition.
Quantra produces adjunctive
information; it is not an
interpretive or diagnostic aid.

mandated by certain state
regulations. The Quantra
software reports a result for each
subject, which is intended to aid
radiologists in the assessment of
breast tissue composition. The
Quantra software produces
adjunctive information; it is not
a diagnostic aid.

• Fibroglandular (dense)
Tissue Volume
• Total Breast Volume
• Volumetric Breast Density
• Area Breast Density
• Volume of Fibroglandular
Tissue Score
• Volumetric Breast Density
Score
• Estimate of Breast Density
(integer)
• Estimate of Breast Density
(fractional)

• Quantra Generated Breast
Density Category

Similar. Uses
distribution of
glandular
tissue rather
than density of
glandular
tissue when
assessing
breast
composition.

Statistical
comparison
to a
reference
population

Same, with the
proposed
device also
being
compared
against a


Quantra2.2 – QDC Tomo (3D Center Projection)


Device
Proposed Device
Primary Predicate
Reference Device

AmCAD-UV
QLAB Quantification
ClearViewHD

Picture archiving and
communications
systems

Picture archiving and
communications
system, workstation

Picture archiving and
communication
system

AmCAD-UV is a
software device
designed for
classifying the
ultrasonic color
intensity data and
allowing users to
view classified
color-coded signals,
namely, primary
pulsatile, secondary
pulsatile, and
unidentified signals
of flow Doppler
ultrasound images. It
is intended as a
general-purpose
medical image
processing tool for
vascular pulsatility
analysis but must not

QLAB Quantification
software is a
software application
package. It is
designed to view and
quantify image data
acquired on Philips
Healthcare
ultrasound products.
The software allows
users to examine
tissue Doppler
imaging and provides
a tool for drawing
regions of interest
that measure the
myocardial velocity,
strain, strain rate,
and displacement
along those regions
in the myocardium

The ClearView Image
Enhancement
System is intended
for use by a qualified
technician or
diagnostician to
reduce speckle noise,
enhance contrast
and transfer
ultrasound images.
The software
provides a
DICOM-compliant
ClearViewHD-enhanc
ed image along with
the original
ultrasound image to
assist in image
interpretation by the
trained physician.
ClearViewHD is

Table 1.6.1 – The substantial equivalence comparison table


be used alone for
primary diagnostic
interpretation.

intended for use by a
qualified
technologist for
transfer and
enhancement of
ultrasound images
from a variety of
diagnostic systems.

Functional
Capability of
Image
Processing

The device provides
dual images for
viewing original
dynamic f and
classified color-coded
signals of flow
Doppler ultrasound
images. The device
also provides a trend
chart for displaying
waveforms of
pulsatile intensity
changes with
summarized
statistics. It is
intended as a
general-purpose
medical image
processing tool for
vascular pulsatility
analysis, such as flow
velocity and flow
energy, over a
number of cardiac
cycles. AmCAD-UV
can export the
quantified values of
the classified
pulsatile signals in
text format and
export the sequence

The software can
display the dynamic
intensity information
as color-coded image
and provide a chart
for displaying the
intensity changes
over time on a
waveform, which is
able to evaluate the
periodic strain
fluctuation in
myocardial tissue
motion over a
number of cardiac
cycles.

The software
generates an
enhanced image
with reduced speckle
noise and improved
contrast
enhancement for
viewing and
diagnosing.


of color-coded
pulsatile images and
the waveform trend
chart in Bitmap
(*.bmp) and JPEG
(*.jpg or
*.jpeg)formats.

Based on
classification method
of ultrasonic color
intensity data
contained in the
dynamic flow
Doppler ultrasound
images (i.e. color and
power Doppler
ultrasound images).

Based on the strain
rate method of
velocity of
myocardial tissue
motion contained in
the dynamic tissue
Doppler images.

Based on a core
noise reduction and
contrast
enhancement
algorithm in
gray-scale ultrasound
images.

AmCAD-UV allows
users to view
classified color-coded
signals, namely,
primary pulsatile,
secondary pulsatile,
and unidentified
signals of flow
Doppler ultrasound
images and trend
chart of intensity
changes over time on
a waveform. The
device exports the
quantified values of
the classified

The software can
display the dynamic
intensity information
as color-coded image
and export the
intensity changes
over time on a
waveform.

The software can
display an image
with enhanced
contrast and reduced
noise.


Device
Proposed Device
Primary Predicate
Reference Device

AmCAD-UV
QLAB Quantification
ClearViewHD

pulsatile signals in
text format and
exports the
sequence of
color-coded pulsatile
images and the
waveform trend
chart in Bitmap
(*.bmp) and JPEG
(*.jpg or
*.jpeg)formats.

The classified
color-coded signals
of flow Doppler
ultrasound images
indicate different
intensity values
defined by the scale
of the color bar.

The color pixels in
the virtual trace
image indicate
different values of
myocardial tissue
motion information
defined by the scale
of the color bar.

The trends of
intensity changes
over a sequence of
frames is used for
evaluation of the
periodic fluctuation
in vascular pulsatility
over a number of

The trends of
myocardial
information at the
user-selected specific
points for evaluation
of the periodic
fluctuation in
myocardial tissue


Average, maximum,
and minimum values
for the trends of
pulsatile intensity
changes.

Mean values for the
trends of dynamic
intensity
information.

Type of File to
be Processed
by the device

Dynamic flow
Doppler ultrasound
images in DICOM,
Bitmap, or JPEG
formats (Vendor
independent).

Dynamic tissue
Doppler image data
acquired on Philips
Healthcare
ultrasound products.

DICOM node that
accepts DICOM3.O
digital medical files
from an ultrasound
device or another
DICOM source.

Standard PC,
workstation, and
on-board
FDA-cleared
ultrasound systems.

Standard PC,
workstation, and
on-board Philips'
ultrasound systems.

Windows XP or
higher, Windows
Embedded and
DICOM-compliant
medical devices.


Feature
UNiD Spine Analyzer
Surgimap 2.0

Operating System
Windows + MAC
Windows + MAC

Image Input
Local
Local + PACS connectivity


si rofyrossecca lanoitnevretni serudecorp ,dnalg snaicisyhp fo noitazilausiv SURT cinilc swolla lacidem -eerht dezitigid a mrof sedivorp noitazilausiv ytiliba etareneg etatonna eht gnirud eb
ecived etatsorp )D2( dnuosartlu ni etatsorp tI .sgnittes smrofrep ot ehT erawtfos eht dna fo ot dednetni dna a ni serudecorp
tegraTtramS yb lanoisnemid-owt tnemges )D3( fo segami .emulov egami gnidulcni ,segami ,sweiv yfitnedi snoitacol detresni citsongaid
na sa dednetni dediug-egami citsongaid eht gnivlovni desu eb decnahne latcersnart eht fo latipsoh ot ti dna lanoisnemid noitcurtsnocer oediv SURT tegraTtramS D3 ,serutaef weiver ranalp-itlum dna eht stnemurtsni .erudecorp si ecived tnemtaert
ot segami resu segami SURT dna ,segami drocer ni
desu
ehT dna dna rof dna eht D3 D2 ehT
ot

ot ,tnemeganam
dednetni D3
eht dna dnuosartlu .dnalg serutaef ,noitcurtsnocer
ni
02 D-3
si snaicisyhp etatsorp
erawtfos rof erawtfos atad egami dna
latipsoh
fo tneitap ,stnemerusaem
eht ,noitatnemges
noitazilausiv
teJoiB yb lanoitiddA ranalpitlum .noitartsiger
fo
ro
desu segami edulcni
cinilc
ehT
eb

egami ,noitcurtsnocer
rof fo dna gnidrocer eht
dna
dednetni noitazilausiv fo gnidulcni ,noitalupinam ,noitartsiger erehw deriuqca
rof gnigami cinilc tI D3 serutaef atad ,tnemerusaem egami
snaicisyhp
.sgnittes dna
si ni D2 noitazilausiv .sloot tneitap ,tnemeganam ,noitatnemges dna snoitacol erew
xB decnahne dnuosartlu etatsorp lanoitiddA ranalpitlum egami ,noitatonna eht .erudecorp
noisuF yb latipsoh sedivorp ,weiver sisylana edulcni egami eht seispoib gnirud
esu eht D3
fo

dediug-egami citsongaid etatsorp D3 dna dnuosartlU ot ytiliba segami sa hcus ,)RM( .cte ,yhpargomoT ot ytiliba fo egami hcus ,eriwediug taht neercs tegrat eht dna eht tnemurtsni tneitap erawtfos atad ranalp-itlum ,noitatnemges dna .noitartsiger
cixatoerets loot a fo tneitap
D2 eht eseht rehto ecnanoseR no ehtfo tnerruc htap stnemerusaem
dna eht sedivorp fo dna retsiger morf seitiladom eht sedivorp detalumis noitresni ,eldeen eborp rotinom erutuf tnuocca rehtO edulcni ,noitcurtsnocer
a rof lanoitnevretni fo noitazilausiv segami ro segami eht lanoitnevretni ,tnemeganam egami
sivaNorU yrossecca serudecorp tI .dnalg dna esoht gnigami citengaM detupmoC osla a yalpsid dekcart yspoib etalp retupmoc swohs dna nagro detcejorp otni gnikat .tnemevom serutaef egami D3/D2
)SU( esuf htiw a dirg
tI a sa


si era nac ,eussit .eussit ,edulcni eldeen selpmas ;etatsorp ,seuqinhcet lacitpo ,ycneuqerfoidar ,yparehtoyrc -yllacol
taht eht evitcaoidar
a hcihw tnemurtsni etatsorp ro muenirep stnemurtsni ot yllanretxe tnemtaert etatsorp noitamrofni etatsorp serudecorp :ot eussit eht no desab eussit desucof cimanydotohp elbisreverri noitatnalpmi dna .seipareht
ni gnittes rehto eht taht ot morf detimil hcihw morf citsongaid lamreht gnisu ,resal ytisnetni-hgih ;noitaroportcele ;)yparehtyhcarb(
otni eht ro denoitisop os dereviled citsongaid ton devomer esoht ,evaworcim ;dnuosartlu gurd
lacinilc ro eldeen detresni hguorht ,arhteru etatsorp deniatbo elpmaxE era ni yspoib utis sa ;gnisnes noitalba ;ypareht ecruos detcejni
hcus
tub era
eb ro ni ro

,serudecorp eussit
desu ,edulcni lacinilc
ehT egami fo
a
rof dna .serudecorp eb ni serudecorp tfos tnemecalp
,lacinilc ro/dna ot dna serudecorp ot citsongaid
dednetni ,seispoib
gninnalp dednetni lanoitnevretni detimil dna .srekram
.gnittes
lanoitnevretni snoitanimaxe dna
rof
si tnemtaert ecnadiug citsongaid si citsongaid elpmaxE ton rof eussit snoitalba
vaNorU ecived lacinilc era noisuf laicudif
tub tfos
ni


seruces msinahcem
a
ot reppets
a
dehcatta fo
dna
snaem
eborp
sdloh gnipmalc )ecived
sredocne
yb
SU
hcihw
eborp
lacinahcem ytrap-driht(
dna
noitisoP
,ecived SU
eldarc
eht

eht naicisyhp
yllaicremmoc dna tcejbus flehs-eht-ffo
sdloh eht
dnuosartlu
reppets
skcart
taht eht
eht
lacinahcem seilbmessa dna elihw fo
na
htiw lamron erudecorp
eborp si
noitisop sihT[
skrow
dnuosartlu a
elbaliava rezilibats smrofrep gnigami .etatsorp
]ecived
teJoiB eborp

dehcatta
trap(
taht
mra eborp
sredocne
detalucitra
SURT
)ecived
noitisoP
a
na sdloh
ot fo

srosnes
eborp
citengamortcele
SU
ot
dehcatta
D3


Trade Name
DM-Density
iReveal (formerly M-Vu

DM-Density is a software
application intended for use
with compatible full field digital
mammography systems. DM-
Density calculates percent
breast density defined as the
ratio of fibroglandular tissue to
total breast area
estimates. DM-Density
provides these numerical

M-Vu Breast Density is a
software application intended
for use with digital
mammography systems. M-Vu
Breast Density calculates breast
density as a ratio of
fibroglandular tissue and total
breast area estimates. M-Vu
Breast Density provides these
numerical values for each


4-category breast density scale
from 4th Ed. ACR BI-RADS Atlas
2003

Subject device
provides users with
the option of utilizing
either the 4th or 5th
edition scales;
Predicate Device
utilizes 4th edition
scale only

4-category breast density scale
from 5th Ed. ACR BI-RADS Atlas
2013

DICOM Structured Report and
Secondary Capture

Data Throughput
600 cases per hour
60 – 120 cases per hour


Claim#
Feature /Component
Labeling Claim

syngo TrueFusion –Add TEE guidance to live
fluoroscopy with ease

Navigate with improved anatomical orientation

3.
syngoTrueFusion
Integrated efficiency in TEE guidance

Reduce complexity in challenging procedures

Navigate with confidence through integrated
TEE guidance

Achieve automated co-registration with eSie
Sync
Automatedprobe detection in 2 single fluoro
images and automatedco-registration updates

eSie Sync integrates co-registration efficiently in
your workflow

Probe detection enhanced by machine learning

Hardware markersand probe model enable
robust algorithm

10.
syngoTrueFusion
Trueintegration of ACUSON SC2000 PRIME

Trueintegration and possibility to synchronize
views enhances communication

Share perspectives efficiently with view
synchronization*

Set landmarks swiftly with eSie Valves modeling

Identify key anatomical landmarks with one-click
eSie Valves modeling

Assess valves and fuse model with live
fluoroscopy at any time during the procedure

Valve modelreduced to the relevant structures
on the fusion image for a clear view of your
devices

Annulus landmark overlay on live fluoroscopy
can help find the perpendicularview.

Target-oriented guidance through TEE structural
information fusion

More intuitive orientation through overlay of TEE
cone on live fluoro*

Direct real-time guidance from the ultrasound
system

syngo TrueFusion can shorten the learning
curve in challenging procedures as it enables
more intuitive anatomical orientation*

Proposed new product claims associated with “syngo TrueFusion”


Claim#
Feature /Component
Labeling Claim

Synchronization of TEE and angioimage
orientation allows to deriveimplantation angles
from TEE.

Assessment of valve morphology with eSie
Valves™ modelingand fusion of relevant
structures supports accurate device placement

Dedicated probe design enables rapid and
reliable registration updates**

Reliableimage fusion with dedicated probe
design and eSie sync

Target-oriented device navigation via True
Volume TEE landmarks

Direct export of fusion landmarksfrom the
compatible ultrasound system.

Overlay of TEE cone on live fluoro for greater
intuition in orientation*

Fast and reliable documentation with integrated
patient co-registration from angiography and
ultrasound systems

C-arm angulation planning without fluoroscopy

A confident clear view combined on one screen

Facilitated communication through first-hand
guidance from the modality expert

Synchronized views can speed up orientation and
communication*

Synchronized views facilitating orientation / for a
faster grasp of orientation*

*This is the result of individual user experience –results may vary
**The quality of registration depends on the orientation of the probe, the angular difference
betweenthe two projections, the C-arm position, and the zoom stage.

syngoApplication Software K170747AI Response


Subject Device
syngo Application
Software

Newly added
software feature:
syngo TrueFusion

The new syngo
TrueFusion software
feature does not raise
any new issues of
safety of
effectiveness.
Validation and testing
was conducted


Added software feature “syngo TrueFusion”

Explanation of sample size and Statistical Methods:

Multiple Measurements were performed from different directions of the C-arm by a
board certified cardiologist.

All results are clinically accepted by a board certified radiologist.

Explanation of Study Acceptance Criteria:

Mean deviation shall not exceed 3mm with a standard deviation not exceeding
2mm.

Multiple Measurements were performed from different directions of the C-arm. The
measurements show these mean and standard deviations from three different C-
Arm positions (A, B, C): Experiment 1 position A mean 2,92mm with a standard
deviation of 1,29mm, position Bmean 2,59mm with a standard deviation of
1,50mm, position C mean 2,31mm with a standard deviation of 1,62mm,
experiment 2 position A mean 2,76mm with a standard deviation of 1,31mm,
position B mean 2,57mm with a standard deviation of 1,69mm, position C mean
2,13mm with a standard deviation of 1,48mm. The statistical significance –
80% successful experiments – is 0,0 for experiment 1 position A, 0,002 for B,
0,002 for C and 0,002 for experiment 2 position A, 0,015 for B and 0,002 for C.
All results were clinically accepted by a board certified cardiologist.

Supportive article reference(s) with explanation as for how it supports the

The comparison of technological characteristic, non-clinical performance data,
clinical images, Human Factor Usability data and software validation data
demonstrates that the subject device is as safe, and effective when compared to
the predicate device that is currently marketed for the same intended use.

Performance Verification/Validation & Test Report Summaries


510(k) Section Number: 5
Document No: 007

NeuroQuant 510(k) Premarket Submission: 510(k) Summary

Revision: 01
Pages 1 of 4
Date: 8/4/2017


Classification Name:
System, Image Processin

Regulation Description:
Picture archiving and com


4690 Executive Drive, Suite 250
San Diego, CA 92121


Common Name:
Medical Image Processing Software

Classification Name:
System, Image Processing, Radiological

Picture archiving and communications system


Revision: 01
Pages 2 of 4
Date: 8/4/2017


Device Name
NeuroQuant™ V1.0
NeuroQuant® V2.2

“Picture archiving and communications system”

Summary Comparison Table for the device and predicate device (K061855):


Revision: 01
Pages 3 of 4
Date: 8/4/2017


Classification Name
System, Image Processing, Radiological
System, Image Processing, Radiological

Automatic labeling, visualization and volumetric
quantification of segmentable brain structures
from a set of MR images, intended to automate
the current manual process of identifying,
labeling and quantifying the volume of
segmentable brain structures identified on MR
images

Automatic labeling, visualization and volumetric
quantification of segmentable brain structures
and lesions from a set of MR images. Volumetric
data may be compared to reference percentile
data

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

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

• Operates on off-the-shelf hardware (multiple

Operating System
Supports Linux and Mac OS X
Supports Linux, Mac OS X and Windows.

Automated internal pipeline that performs:
- artifact correction
- segmentation
- lesion quantification
- volume calculation
- report generation

• MRI scanner: 3D T1 MRI scans acquired with

• NeuroQuant Supports DICOM format as input

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

• Results must be reviewed by a trained physician

Revision: 01 Pages 3 of 4 Date: 8/4/2017


Output ▪ Provides volumetric measurements of brain ▪ Provides volumetric measurements of brain


510(k) Section Number: 5
Document No: 007

NeuroQuant 510(k) Premarket Submission: 510(k) Summary

Revision: 01
Pages 4 of 4
Date: 8/4/2017


Hatanpään valtatie 24, FI 33 100 Tampere,
Finland


Common Name
Medical Image Processing Software

Classification Name
System, Image processing, Radiological


1
9
=@
+
D
D
=9
E F
:
G 0
. H /
9
I J
K
L
J MJ L N

)
O
D
A= ;
CA9
<
(
;
CF
G P
; < > ;
=Q
R
L
S N
J L T

]
‘ a
]
l
U
V
V
W X
Y
U
Z[
ZV
\ V
] Z ^ V
_‘
a
b

0
E F
=M-
‹
F
M8
9
>
<
CF
=
4
B F
d
N L
8
1 ,
« J
L 5 > g
D
;
= C
8
f

›
fi fl
(cid:176)
–fl
† ‡
fi
fl · (cid:181) ‡ ¶ ·
•
· (cid:176) ‡
¶
·
‚ ‡
–„
fl
‡
‡
”
‡
”
»


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


Ultrasonic Pulsed Echo Imaging System
21 CFR 892.1560
IYO

Diagnostic Ultrasound Transducer
21 CFR 892.1570
ITX


Comparison Category
Verathon BladderScan® PRIME
Predicate Verathon BladderScan®

FDA Ultrasound Guidance Track
Identical to predicate
Track 1

employ the same fundamental technology. The comparison table is provided below.


System, Imaging, Pulsed Echo,
Ultrasonic

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

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

Anatomical Site
Identical to predicate
Bladder

Users
Identical to predicate
Physicians/Medical Professionals

Technological Characteristics and Performance

Lexan Polycarbonate Plastic HP1-
1H112 (colorant: PCM 84907 Dark
Gray 424C)

Sterility
Identical to predicate
Non-sterile

Power Source
Identical to predicate
Electrical (Lithium-ion battery)

Energy Delivered
Identical to predicate
Ultrasound

Measurement Range
Identical to predicate
0 to 999 mL

Controls to Change Acoustic
Output During Scan

Modes of Operation
Identical to predicate
B-mode

Transducer Type
Identical to predicate
Mechanical Sector Probe

Transducer Diameter
Identical to predicate
13 mm

Number of Elements
Identical to predicate
1


Comparison Category
Verathon BladderScan® PRIME
Predicate Verathon BladderScan®

Transducer Resonant Frequency
Identical to predicate
2.95 MHz

Sector Angle
Identical to predicate
120 degrees

Number of Scan Planes
Identical to predicate
12

Touchscreen Operation
Identical to predicate
Yes

Selectable Unit Orientation
(Patient Right/Left)

Live Scan Image
Identical to predicate
Yes

Procedure Type selection on
user interface

Single mode of operation
accommodating
Male/Female/Small child

Male/Female/Small Child mode
selection screen and If female:
Uterus or no uterus selection

Calibration
No Calibration recommended
Annual Calibration recommended

Data Connections
Identical to predicate
USB, SD card

Attached Printer
Identical to predicate
Yes

Printer, battery, battery charger,
power cord, mobile cart

Acoustic Output: Maximum
Mechanical Index (MI)

Acoustic Output: Maximum
Thermal Index (TI)

Acoustic Output: Intensity,
Spatial Peak Temporal Average
(I )
SPTA

Acoustic Output: Intensity,
Spatial Peak Pulse Average (I )
SPPA


Predicate Verathon BladderScan®
PRIME System
(K153101)

Electromagnetic Compatibility
Standard Compliance


ISO 10993-1:2009/R(2013) Biological Evaluation of Medical Devices. Part 1:
Evaluation and Testing

AAMI / ANSI / ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical

Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)

ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation of Medical

Devices – Part 10: Test for Irritation and Skin Sensitization.

AAMI / ANSI / ISO 10993-12:2012, Biological Evaluation Of Medical Devices -

Part 12: Sample Preparation And Reference Materials. (Biocompatibility)

A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1:

General Requirements For Basic Safety And Essential Performance (IEC

AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical Electrical Equipment -
Part 1-2: General Requirements for Basic Safety and Essential Performance
– Collateral Standard: Electromagnetic Compatibility - Requirements and
Tests (Edition 3)


IEC 60601-2-37:2007 Medical Electrical Equipment. Part 2-37: Particular
Requirements for the Basic Safety and Essential Performance of Ultrasonic
Medical Diagnostic and Monitoring Equipment.

Standard for Real Time Display of Thermal and Mechanical Acoustic output
Indices on Diagnostic Ultrasound Equipment.

Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment.

AAMI / ANSI / ISO 14971:2007/(R) 2010 (Corrected 4 October 2007),

Medical Devices - Applications of Risk Management to Medical


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. (General I (QS/RM))

AAMI/ANSI HE75:2009/(R)2013, Human Factors Engineering – Design of
Medical Devices. (General I (QS/RM))

IEC 62366-1 Edition 1.0 2015-02, Medical Devices – Part 1: Application of

Usability Engineering to Medical Devices [Including Corrigendum 1 (2016)].

ISO 13485:2003, Medical Devices Quality Management System –
Requirements for Regulatory Purposes


Fetal Imaging & Other
Fetal
P
N
N
N
B+M; B+CD; B+PD

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

Intra-operative (Abdominal
organs & vascular)

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

Small Organ (Thyroid, Prostate,
Scrotum, Breast)

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

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

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

Other (Fetal Echo)
P
N
N
N
B+M; B+CD; B+PD

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

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

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


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

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

N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Needle Enhancement in B-Mode.


Fetal Imaging & Other
Fetal
N
N
N
N
B+M; B+CD; B+PD

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

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

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

Other (Fetal Echo)
N
N
N
N
B+M; B+CD; B+PD

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


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

Intra-operative (Abdominal
organs & vascular)

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

Small Organ (Thyroid, Prostate,
Scrotum, Breast)

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

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

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

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


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

Diagnostic ultrasound imaging and
fluid flow analysis

− 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

−
− Fetal
− Abdominal
−
−
− Pediatric
− Small organ
−
−
−
−
− 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
−
−
−
− Combined (B+M, B+CD, B+PD)

− B-Mode
−
−
−
−
−
−
−
−


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

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 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:


 Same as predicate except
for the operating system.
 Runs on Microsoft
Windows 7 / 8.1 / 10

 Runs on Microsoft
Windows XP / Vista / 7 /
8.1
 Supports a combination
of various types of
monitors including VGA
and high-resolution
monitors
 Integration-less
synchronization of PACS
and 3D functions
 Automatically detects
monitor resolution and
magnification
 Intuitively applies setting
values
 Links internal viewer to
external HIS/RIS report
system
 Supports launching
external programs with
various parameter from
specified exam
information
 Supports Direct CD/USB
Burning and Media
server backup
 Supports Anonymize
Direct CD/USB Burning
and Media server
 Stores all user settings in
the database (Roaming
user profile)

Differences: Subject
Device does not run on
Microsoft XP or Vista.
The differences
between the subject
device and the
predicate device is due
to the advancement in
computer OS
technology since the
time predicate device
was cleared by FDA.
Microsoft XP or Vista
are no longer supported
by Microsoft.
The differences
indicated, do not raise
any new potential
safety risks and
therefore, there is no
impact on safety or
efficacy for the subject
device.

 DICOM JPEG compression
 DICOM JPEG2K
compression
 DICOM Security (TLS)
 DICOM Multi-frame
 DICOM Storage (SCU)
 DICOM DIR - FSC, FSR,
FSU
 DICOM Query/Retrieve
(SCU)
 DICOM Grayscale Softcopy
Presentation State (GSPS)

510(k) Summary of Safety and Effectiveness


Softcopy Presentation
State (GSPS)
 DICOM Key Image Note
 DICOM Multi-bytes
character set
 DICOM Print

 Supports secured network
protocol
 Supports auto log off
 Supports audit logging
 Restricting user behavior
based on user roles and
the institutional policies

General
 Supports various worklist
mode
 Study list
 Favorite folder
 DICOM QR
 DICOM DIR
 Case
 Conference
 Technician worklist
 Embedded web
browser
 Viewed history
 Supports short cut button
for the specific folders of
each worklist mode (Quick
access)
 Support open the DICOM
files directly (local open)
Study list
 Searches the exams that
meet the multiple search
conditions
 Configurable fetching count
for the exams.
 Exam list displays various
information describing the
exams.
 Add, delete, change
position and sort of each
information with header
column control
 Supports refreshing the
exam list automatically by
user configuration

General
 Supports various worklist
mode
 Study list
 Favorite folder
 DICOM QR
 DICOM DIR
 Case
 Support open the DICOM
files directly (local open)
Study list
 Searches the exams that
meet the multiple search
conditions
 Configurable fetching
count for the exams.
 Exam list displays
various information
describing the exams.
 Add, delete, change
position and sort of each
information with header
column control
 Supports refreshing the
exam list automatically
by user configuration
 Exports the list of the
selected exams to text
file or MS Excel
compatible file (CSV)
 Supports
create/edit/delete search
folders that contains the
predefined search
conditions

Yes, there are
differences. There is
additional functionality
in the subject device.
The added features and
functions of the subject
device is described in
labeling, so the User
will be aware of the
system functionality.
The additional items do
not change the
Inductions for Use as
compared to the
predicate. The
differences do not raise
any new potential
safety risks and
therefore, we believe
there is no impact on
safety or efficacy for the
subject device.


 Searches order and exam
List
 Matches or un-matches the
selected order and exams
 Merges or un-merges the
exam
 Splits the series from the
exam to new one
 Modifies the information of
the exam or the series
Embedded web browser
 Browses the web pages
with predefined web URL
Dash Board
 Queries the number of
exams that are met the
specified condition
 Shows the study list that
are met the specified
conditions
Notification
 Notices predefined
schedules or events to
PACS user.

 Displays the DICOM
images which are stored in
PACS storage
 Accesses historical exams
and report : Timeline, Exam
list
 Supports image
arrangement and
manipulation using toolbar
buttons, shortcut keys or
screen shortcut
 Support user-configurable
mouse button action
 Configures the initial
settings for each specific
modality
 Supports job saving
 Export or convert the
displayed images as
DICOM or general image
formats

 Displays the DICOM
images which are stored
in PACS storage
 Accesses historical
exams and report : Exam
list
 Supports image
arrangement and
manipulation using
toolbar buttons or
shortcut keys
 Support user-
configurable mouse
button action
 Configures the initial
settings for each specific
modality
 Supports job saving
 Export or convert the
displayed images as
DICOM or general image
formats

Yes, there is an added
“Findings List” feature
in the subject device.


 Zoom
 Windowing
 Magnification
 Fit
 Capture
 Reset
 Print: Report / Film
 3D cursor
 Exam Refresh
 Dictation (play, record)
 Set as tape dictated
 Hide demographic
information
 Save snapshot
 Apply previous / next HP
sequence
 Specific zoom: 100%, 1:1
Display (Monitor screen)
Annotation /
Measurement tools
Image Display
3D Tools
Etc tools
 Display DICOM information
tool
 Monitor cine controller
 Save
 Call case folder
 External link
 About

 Zoom
 Windowing
 Magnification
 Fit
 Capture
 Reset
 Print: Report / Film
 3D cursor
 Exam Refresh
 Dictation (play, record)
 Set as tape dictated
 Hide demographic
information
 Save snapshot
 Apply previous / next HP
 Specific zoom: 100%, 1:1
Display (Monitor screen)
Annotation /
Measurement tools
Image Display
3D Tools
Etc tools
 Display DICOM
information tool
 Monitor cine controller
 Save
 Call case folder
 External link
 About

The added feature is
described in labeling,
so the User will be
aware of the system
functionality. The
additional item does not
change the Inductions
for Use as compared to
the predicate. The
difference does not
raise any new potential
safety risks and
therefore, we believe
there is no impact on
safety or efficacy for the
subject device.

 Thumbnail display: series,
image
 Displays series number and
how many images are in
specific series
 Displays an icon about the
property of the series: Only
one image in series,
Multiple images in series,
Multi-frame image in series
 Supports opening the
series or image by drag
and drop the thumbnail or
click it

 Thumbnail display:
series, image
 Displays series number
and how many images
are in specific series
 Supports opening the
series or image by drag
and drop the thumbnail
or click it

Yes, there is a
difference in that the
subject device displays
an icon about the
property of the series:
Only one image in
series, Multiple images
in series, Multi-frame
image in series. The
added feature is
described in labeling,
so the User will be
aware of the system
functionality. The
additional item does not
change the Inductions
for Use as compared to
the predicate. The
difference does not


 Supports monitor merge
 Supports displaying
multiple exams in a monitor
by image set layout
 Supports displaying
multiple series or images in
the image set by cell layout

 Displays the information of
the patients that are
opened
 Displays the list of all
historical exams or relevant
exams only for specific
patient
 Displays the report text of
the specific historical exam
 Displays the series
thumbnails of the specific
historical exam
 Displays jobs and
snapshots in this area
when creating it. (Job
container)

Yes, differences. This is
a new feature that is
not in the predicate
device. The added
features and functions
of the subject device is
described in labeling,
so the User will be
aware of the system
functionality. The
additional items do not
change the Inductions
for Use as compared to
the predicate. The
differences do not raise
any new potential
safety risks and
therefore, we believe
there is no impact on
safety or efficacy for the
subject device.

 Applies the user
configurable hanging
protocol for each type of
exam when it is opened
 Support tools for managing
user hanging protocols:
Create / Copy / Export /
Import / Copy from another
user / Delete / Search
 Support user configuration
for below settings in a
hanging protocol
 Support multiple layout
sequences in a hanging
protocol (hanging protocol
layout group)

Yes, there is a
difference between the
subject and predicate
devices. The subject
support multiple layout
sequences in a hanging
protocol (hanging
protocol layout group).
This is a new feature
that is not in the
predicate device. The
added features and
functions of the subject
device is described in
labeling, so the User
will be aware of the
system functionality.
The additional items do


not change the
Inductions for Use as
compared to the
predicate. The
differences do not raise
any new potential
safety risks and
therefore, we believe
there is no impact on
safety or efficacy for the
subject device.

 Support display mode:
Stack / Image / Preset (VR
/ MPR / MIP / Web URL /
Report)
 Maximize and restore
displayed image
 Support crosslink among
the series in same study
 Support linked scrolling
among the exams, even for
difference exams
 Support linked scrolling by
manual-selection
 Support monitor cine
control for stack mode
 Sets as key image
 Rearranges the images by
image information (Sort):
image time/number/echo
time/image position
 Supports sequence display
(Position/Time) for specific
data

 Support display mode:
Series / Image / Preset
(VR / MPR / MIP / Endo /
FMX)
 Maximize and restore
displayed image
 Support crosslink among
the series in same study
 Support linked scrolling
among the exams, even
for difference exams
 Support linked scrolling
by manual-selection
 Support monitor cine
control for series mode
 Sets as key image
 Rearranges the images
by image information
(Sort): image
time/number/echo
time/image position
 Supports sequence
display (Position/Time)
for specific data

 Adjustable blending rate
 Separated windowing for
each fusion data
 Screen capture for further
use

 Manually adjusted
registration
 Adjustable blending rate
in MIP/MPR fusion
 Separated windowing for
each fusion data

 Mammo CAD interface: R2
 Mammo CAD interface : i-
CAD SR
 Mammo Hanging Protocol
Loop Sequence
 Mirror function: Zoom,

 Mammo CAD interface:
R2
 Mammo CAD interface :
i-CAD SR
 Mammo Loop Sequence
 Mirror function: Zoom,


Magnification, Pan, B/W
Invert
 Quadrant Zoom
 Clear Filter
 Custom View Layout
 Auto breast fit display
 Breast Tomosynthesis view
mode
 Controlled with INFINITT
Mammo Keypad (option)

Volume Rendering
 OTF windowing: See below
in more detail
 Interactive 3D rendering
reflecting the change of
OTF
 VOI display (slab
rendering): See below in
more detail
 Batch rendering
 Orientation cube display
 Orientation preset
 Bounding box display
 Synchronize VR with MIP
MPR
 Supports classic
reformation planes: Axial,
Sagittal, Coronal and
Oblique plane
 Supports image scroll using
mouse drag on images
 Various crosshair shape:
Show/Hide, Hollow, Small
size
 Double oblique MPR
 Curved MPR
 Rotate reformation plane
 Batch MPR with cine
support
 Slab MPR: Raysum, MIP,
MinIP

General
 Prints the images and
report with paper or DICOM
printer
 Sends the images and


Proprietary Name
CSCS-001A Calcium Scoring Package

Premarket Notification
K072737 (5 Oct. 2007)

Classification Name
Computed tomography x-ray system

The HealthCCS device is substantially equivalent to the following device:


Picture archiving and communications system


Proposed
Device:
HealthCCS
software tool

Predicate Device:
CSCS-001A,
Calcium Scoring
Package (K072737)

Reference Device
Kodak Carestream
PACS (K053347)

Supported
Computed
Tomography
(CT) scan – body
part

Supported
Computed
Tomography
(CT) scan – dose

Supported
Computed
Tomography
(CT) scan – Use
of IV contrast


Supported
Computed
Tomography
(CT) scan – ECG
Gating/Triggering

Selection of a
calcified plaques
based on voxel
identification
above a known
threshold

Coronary
Calcification
calculation
method

Agatston
equivalent score
based on the
Agatston method

- Agatston score
- Mass score
- Volume score

Total calcium score,
and per-artery
calcium score

Maintain a
patient database
for future
reference


Microsoft Corp
1 Microsoft Way
Redmond, WA 98052
Phone: 425-538-9419

Donna-Bea Tillman, Ph.D, MPA
Biologics Consulting Group, Inc.
1555 King Street, Suite 300
Alexandria, VA 22314
Phone: 410-531-6542
dtillman@biologicsconsulting.com


Common or Usual Name:
Radiological Image Processing System

Picture Archiving and Communications System
21 CFR 892.2050


No reference devices were used in this submission.


892.2050 – Picture Archiving and
Communication System

Microsoft Radiomics Advanced
Image Contouring v1.0 (Radiomics
App) is a software-only medical
device intended for use by trained
radiation oncologists, dosimetrists
and physicists to derive optimal organ
and tumor contours for input to
radiation treatment planning.
Supported image modalities are
Computed Tomography and Magnetic
Resonance. Radiomics App assists in
the following scenarios:
Load, save and display of medical
images and contours for treatment
evaluation and treatment planning.
Creation, transformation, and
modification of contours for
applications including, but not limited
to: transferring contours to
radiotherapy treatment planning
systems, aiding adaptive therapy, and
archiving contours for patient follow-
up.
Localization and definition of both
solid tumors and healthy anatomical
structures.
Fusion display of compatible images
for treatment planning.
Three-dimensional rendering of
medical images and the segmented
contours.
Images reviewed using the Radiomics

MIM 5.2 software is used by trained
medical professionals as a tool to aid in
evaluation and information management
of digital medical images. The medical
image modalities include, but are not
limited to, CT, MRI, CR, DX, MG, US,
SPECT, PET and XA as supported by
ACRINEMA DICOM 3.0. MIM 5.2
assists in the following indications
Receive, transmit, store, retrieve, display,
print, and process medical images and
DICOM objects.
Create, display and print reports from
medical images.
Registration, fusion display, and review
of medical images for diagnosis,
treatment evaluation, and treatment
planning.
Evaluation of cardiac left ventricular
function and perfusion, including left
ventricular end-diastolic volume, end-
systolic volume, and ejection fraction.
Localization and definition of objects
such as tumors and normal tissues in
medical images.
Creation, transformation, and
modification of contours for applications
including, but not limited to, quantitative
analysis, aiding adaptive therapy,
transferring contours to radiation therapy
treatment planning systems, and
archiving contours for patient follow-up

proposed Radiomics App and the predicate MIM Software.


App software should not be used for
primary image interpretations.
Radiomics App is not for use with
digital mammography.

and management.
Quantitative and statistical analysis of
PET/SPECT brain scans by comparing to
other registered PET/SPECT brain scans.
Planning and evaluation of permanent
implant brachytherapy procedures.
Lossy compressed mammographic
images and digitized film screen images
must not be reviewed for primary image
interpretations. Images that are printed to
film must be printed using a FDA-
approved printer for the diagnosis of
digital mammography images.
Mammographic images must be viewed
on a display system that has been cleared
by the FDA for the diagnosis of digital
mammography images. The software is
not to be used for mammography CAD.

Intended users
Healthcare providers
Healthcare providers

Contouring modes
Assisted and automatic
Assisted and automatic

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

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

Fuse medical images from multiple
modalities

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

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

Stand-alone package which operates on
both Windows and Mac computer
systems.


Extensible Imaging (QTxI)
EXINI, K122205
MIM4.1 (Seastar), K071964

Subject Device
Predicate Device
Supporting Predicate Device

Review Panel
Radiology
Radiology
Radiology
No difference

MEQIA, IBIS Explorer and Markup
Software (K111319)

MIM4.0 (K060816); IKOEngelo
(K061006); Centricity PACS
(K043415)

510(k)/ Type
K173444, Traditional
K122205, Traditional
K071964, Traditional
No difference

Receive, store, retrieve, display
and process digital medical
images, as well as create,
display and print reports from
those images

Software tool set for acceptance, transfer,
storage, image display, manipulation and
quantification of digital medical images.

Receive, transmit, store, retrieve,
display, print and process digital
medical images, as well as create,
display and print reports from those
images

DICOM CT and PET as
supported by
ACR/NEMA DICOM 3.0

Nuclear imaging (NM) and computed
tomography (CT) as supported by
DICOM 3.0 standard.

CT, MRI, CR, DX, MG, US,
SPECT, PET and XA as supported
by ACR/NEMA DICOM 3.0.

QTxI does not utilize
as many medical
modalities as
predicate, but does
utilize equivalent
modalities in those
used by both systems.

QTxI uses newer
versions of MicroSoft
Windows software

Identifies Regions of Interest
(ROI) and performs ROI
contouring allowing
quantitative/statistical analysis
of full or partial-body scans
through registration to template
space

The device uses image processing
techniques for segmentation of skeletal
regions, normalization and hotspot
contouring/ segmentation. This device is
semi-automatic in that it requires a
manual step (hotspot verification step)
where the user reviews and edits the
selection of hotspots that are used as
input for quantitative analysis. The device
performs quantitative analysis based on
2D ROI (regions of interests)
measurements in whole body bone scans.

Generates contours using a
deformable registration technique
which registers pre-contoured
patients to target patients.
Registrations are either between a
serial pair of intra-patient volumes
or between a pre-existing atlas of
contoured patients and a patient
volume

All devices perform
centering analyses
utilizing a template
model. QTxI also
registers regions of the
patient.


Extensible Imaging (QTxI)
EXINI, K122205
MIM4.1 (Seastar), K071964

Subject Device
Predicate Device
Supporting Predicate Device

Quantitative Total Extensible
Imaging (QTxI) is a software
tool used to aid in evaluation
and information management of
digital medical images by
trained medical professionals
including, but not limited to,
radiologists, oncologists,
nuclear medicine physicians,
medical imaging technologists,
dosimetrists and physicists. The
medical modalities of these
medical images include DICOM
CT and PET as supported by
ACR/NEMA DICOM 3.0.
QTxI assists in the following
indications:
 Receive, store, retrieve,
display and process digital
medical images
 Create, display and print
reports from those images
 Provide medical
professionals with the
ability to display, register,
and fuse medical images

EXINI is intended to be used by trained
healthcare professionals and researchers
for acceptance, transfer, storage, image
display, manipulation, quantification and
reporting of digital medical images. The
system is intended to be used with images
acquired using nuclear imaging (NM) and
computed tomography (CT). The software
provides general
Picture Archiving and Communications
System (PACS) tools and a clinical
application for oncology including lesion
marking and analysis.

MIM 4.1 (SEASTAR) software is
used by trained medical
professionals as a tool to aid in
evaluation and information
management of digital medical
images. The medical image
modalities include, but are not
limited to, CT, MRI, CR, DX, MG,
US, SPECT, PET and XA as
supported by ACR/NEMA DICOM
3.0. MIM 4.1
(SEASTAR) assists in the following
indications:
 Receive, transmit, store,
retrieve, display, print, and
process medical images and
DICOM objects.
 Create, display and print
reports from medical images.
 Registration, fusion display,
and review of medical images
for diagnosis, treatment,
evaluation, and treatment
planning.
 Evaluation of cardiac left
ventricular function and
perfusion, including left
ventricular end-diastolic
volume, end-systolic volume,
and ejection fraction.

All systems are used to
receive, store, retrieve,
display, and process
medical images and
DICOM objects.
This is accomplished
via registration to a
template space and
subsequent analysis of
the image data.
The predicate device
has multiple uses in
the therapeutic space,
which is not specific to
any device.


 Identify Regions of
Interest (ROIs) and
perform ROI contouring
allowing quantitative/
statistical analysis of full or
partial body scans
 Evaluate quantitative
change in ROIs (total or
partial body; individual
ROI within individual) with
3D interactive rendering of
images with highlighted
ROIs.

 Localization and definition of
objects such as tumors and
normal tissues in medical
images.
 Creation, transformation, and
modification of contours for
applications including, but not
limited to, quantitative analysis,
aiding adaptive therapy,
transferring contours to
radiation therapy treatment
planning systems, and
archiving contours for patient
follow-up and management
 Quantitative and statistical
analysis of PET/SPECT brain
scans by comparing to other
registered PET/SPECT brain
scans.


51 Federal St. Suite 305
San Francisco, CA 94107

Email: quality@arterys.com
Phone: 650-391-7111


Classification Name
System, Image Processing, Radiological


Premarket Notification
Premarket Notification
K101749


Premarket Notification
Premarket Notification
K163253


Predicate Device
(Primary):
syngoTM TrueD
(K101749)

Reference
Device:
Arterys Cardio
DL
(K163253)

Complies with
DICOM & DICOM
RT Standards


Linear Dimension
Calculation for
Volumetric
Segmentation

Yes,
longest linear
dimension (mm) in
axial plane, and
orthogonal to longest
linear dimension

Yes, basic reporting
and
LI-RADS and Lung-
RADS observation
reporting based on
standard guidelines

Yes, available only
for lung CT and liver
MR studies

Yes, available for
ventricular
segmentation


Predicate Device
DENSEEMAMMO v1.0 (K152009)

Software level of concern
Moderate
Moderate

Device type
Not an interpretive or diagnostic aid
Not a diagnostic aid

DenSeeMammo is a software
application intended for use with digital
mammography systems.
DenSeeMammo estimates BI-RADS
breast density value by analyzing
processed digital 2D mammograms
using a fully automated comparison
procedure.
DenSeeMammo provides a BI-RADS
breast density 5th Edition category to
aid radiologists in the assessment of
breast density.
DenSeeMammo produces adjunctive
information. It is not an interpretive or
diagnostic aid when the final
assessment of breast density category is
made by an MQSA-qualified interpreting
physician.
DenSeeMammo core software has been
built and tested on OS X based
computers. DenSeeMammo graphical
use interface software has been built
and tested on Windows, OS X and Linux
based computers.

DenSeeMammo is a software application
intended for use with Full Field Digital
Mammography systems.
DenSeeMammo estimates BI-RADS
breast density category by analyzing
processed digital 2D mammograms using
a fully automated comparison procedure.
DenSeeMammo provides a BI-RADS
breast density 5th Edition category to aid
radiologists in the assessment of breast
density.
DenSeeMammo produces adjunctive
information. It is not a diagnostic aid
since the final assessment of breast
density category is made by an MQSA
qualified interpreting physician.
DenSeeMammo core software has been
built and tested on OS X based
computers.
DenSeeMammo graphical use interface
software has been built and tested on
Windows, OS X and Linux based
computers.
DenSeeMammo v1.2 is compatible for
images obtained from GE Senographe
Essentials and Hologic Selenia Dimension
systems.

Intended users
Radiologists
Radiologists

Symptomatic and asymptomatic women
undergoing mammography

Image source
Digital mammography images
Digital mammography images

GE and Hologic Digital Mammography
systems

Provides results per patient based on
the maximum density category of the
two breasts

Comparison to qualified databases
containing images previously visually
assessed by MQSA-qualified radiologists
using ACR BI-RADS V recommendations

Table 1 Substantial Equivalence comparison table


For each breast: BI-RADS V breast
density category
For each patient: BI-RADS V breast
density category

Software core: OS X based computers
Software graphical user interface:
Windows, OS X or Linux based
computers

Deployment
Stand-alone computer
Stand-alone computer


Supports High
Resolution
Diagnostic
Monitors

Communication and Interoperability with other image management systems

Supports DICOM
studies received
from different
modalities types

Yes
CT, MR, US, XA, DX, CR,
RF, PET, SC, SPECT,
as well as hospital/radiology
information system

Table No.2- 1 Technological characteristics comparison


Yes
▪ Up to 50 concurrent users
using hosted client
▪ Up to 150 concurrent users
using Enterprise Viewer

Supports receiving, sending,
storing and displaying studies
received from the following
modalities via DICOM:
CT, MR, US, XA, DX, CR,
RF, PET, SPECT and SC as
well as hospital /radiology
information systems.

Supports receiving, sending, storing
and displaying studies received from
the following modalities via DICOM:
CT, MR, US, XA, DX, CR, RF, PET
and SC as well as hospital /radiology
information systems.


Comparison and
Synchronization
between volumetric
series

Advanced vessel
analysis
visualization and
evaluation mode -
Vascular
Quantification
Inspector (Vascular
Inspection Mode)

Incorporation of
non-imaging data in
patient context
(Patient Briefing)


Parameter
Predicate Device
Subject Device

Intended for use by qualified
trained medical professionals for
enhancement of MRI images that
are transferred in the network in
DICOM format.

Data input
MRI images in DICOM format
The same

Data output
MRI images in DICOM format
The same


Bay Labs EchoMD Automated Ejection
DiaCardio, Ltd, LVivo EF Software

Fraction Software Application
Application (K130779, Predicate)

The Bay Labs, Inc. EchoMD Automated
Ejection Fraction software is used to
process previously acquired transthoracic
cardiac ultrasound images, to store images,
and to manipulate and make
measurements on images using a personal
computer or a compatible DICOM-
compliant PACS system in order to provide
automated estimation of left ventricular
ejection fraction. This measurement can be
used to assist the clinician in a cardiac
evaluation.

DiaCardio's L Vivo EF Software
Application is intended for non-invasive
processing of already acquired
echocardiographic images in order to
detect, measure, and calculate the left
ventricular wall for left ventricular
function evaluation. This measurement
can be used to assist the clinician in a
cardiac evaluation.

Comparison Table: EchoMD AutoEF versus Predicate


Fully automated, including clip selection

Fully automated (with manually-
selected clips)

Biplane (non-segmentation/non-
endocardial trace)

Biplane Method of Disks
Segmentation (endocardial trace)

Offline EF evaluation
using clips from multiple
ultrasound scanners

Qualitative and quantitative user
feedback on transthoracic cardiac
ultrasound image quality

Manual editing of
automated result by
user

Not internal. Uses manual trace option
PACS workstation


Predicate Device
VentriPoint Medical System IS-1
(K150628)

The VMS System is an adjunct to
existing ultrasound imaging
systems and is intended to record,
analyze, store and retrieve digital
ultrasound images for
computerized 3-dimensional
image processing.
The VMS system is indicated for
use where RV volumes and
ejection fractions are warranted or
desired.

The VMS+ system is
an adjunct to existing
ultrasound imaging
systems and is
intended to record,
analyze, store and
retrieve digital
ultrasound images for
computerized 3-
dimensional image
processing.
The VMS+ system is
indicated for use
where Left Ventricle
(LV), Right Ventricle
(RV), Left Atrium (LA),
and Right Atrium (RA)
volumes and ejection
fractions are warranted
or desired.

intended use and technological characteristics.


IEC 60601-1, Medical electrical equipment – Part 1:
General requirements for basic safety and essential
performance 3rd edition.

Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance
Collateral standard: Electromagnetic compatibility –
Requirements and tests 2nd edition.

Medical devices – Application of risk management to
medical devices

comply with the following voluntary standards:


Eva van Rikxoort
Managing Director
Thirona BV
Toernooiveld 300
6525 EC Nijmegen
the Netherlands
Phone: +31 (0)647142838
E-mail: evavanrikxoort@thirona.eu

Predicate Classification
Class II, 21 CFR 892.1750

Reference Device
Imbio CT Lung Density Analysis Software

Reference Classification
Class II, 21 CFR 892.1750


VIDA PW2
VIDA
Diagnostics
K083227
(Predicate
Device)

Software Accessory to a
Computed tomography
x-ray system


The Thirona LungQ
software provides CT
values for pulmonary
tissue which is essential
for providing
quantitative support for
diagnosis and follow up
examination. The
LungQ software can be
used to support
physician in the
diagnosis and
documentation of
pulmonary tissues
images (e.g.,
abnormalities) from CT
thoracic datasets. Three-
D segmentation and
isolation of sub-
compartments,
volumetric analysis,
density evaluations,
fissure evaluation, and
reporting tools are
provided.


Provides Segmentation
of the:
• Left Lung
• Right Lung
• Left Upper Lobe
• Left Lower Lobe
• Right Upper
Lobe
• Right Middle
Lobe
• Right Lower
Lobe

Ability to measure
volume for:
• Both Lungs
• Left Lung
• Right Lung
• Left Upper Lobe
• Left Lower Lobe
• Right Upper Lobe
• Right Middle Lob
• Right Lower Lobe


Ability to measure
volume at multiple
density ranges for:
• Both Lungs
• Left Lung
• Right Lung
• Left Upper Lobe
• Left Lower Lobe
• Right Upper Lobe
• Right Middle Lob
• Right Lower Lobe

Ability to measure the
15th percentile density
analysis

Does not perform low
density cluster analysis

Does perform low
density cluster
analysis


Control subjects: current or former
smokers without airflow limitation

Subjects with COPD but with minimal
airflow limitations

Subjects with COPD and with moderate to
severe airflow limitations

Subjects with preserved ratio but impaired
spirometry

distribution of subjects with respect to their disease state is provided below.


Imaging parameters
Equivalence study
Fissure analysis

Slice thickness
0.625 - 0.9 mm
0.6 - 1.5 mm

LightSpeed16; LightSpeed VCT;
Sensation 64; Definition; Sensation 16;
Definition AS+; SOMATOM Definition
Flash; Brilliance 64; LightSpeed Pro 16;
Discovery CT750 HD; SOMATOM
Definition

Mx8000 IDT 16; iCT
128; Volume Zoom;
Emotion 16; Sensation
64; Definition;
SOMATOM Definition;

Reconstruction algorithms
Filtered back projection
Filtered back projection

analysis of LungQ 1.1.0 significantly outperforms the previously published version.


Absolute difference of the relative
volumes [pp]

Results of comparison between manual and automatic brain tissue segmentation. Reported values

are averages ± std. dev., computed over 6 segmented slices of 33 scans. The Dice index provides

a measure for overlap of manual and automatic segmentations (1 = perfect overlap). The absolute

differences of the relative volumes (of the brain tissues) are averages ± std. dev. in percentage


Computer
PC Compatible
PC Compatible
PC Compatible

Operating
Windows + MAC
Windows + MAC
Windows + MAC

Table 1: Substantial Equivalence Comparison


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

iSchemaView's RAPID is an image
processing software package to be used
by trained professionals, including but
not limited to physicians and medical
technicians. The software runs on a
standard "off-the-shelf" computer or a
virtual platform, such as VMware, and
can be used to perform image viewing,
processing and analysis of brain
images. Data and images are acquired
through DICOM compliant imaging
devices.
iSchemaView's RAPID provides both
viewing and analysis capabilities for
functional and dynamic imaging
datasets acquired with CT Perfusion
and MRI including a Diffusion Weighted
MRI (DWl)Module and a Dynamic
Analysis Module (dynamic contrast
enhanced imaging data for MRI and
CT).
The DWl Module is used to visualize
local water diffusion properties from the
analysis of diffusion weighted MRI data.
The Dynamic Analysis Module is used
for visualization and analysis of dynamic
imaging data, showing properties of
changes in contrast over time. This
functionality includes calculation of
parameters related to tissue flow
(perfusion) and tissue blood volume.

Computer
Standard “Off-the-Shelf” PC
Same