Automatic
capture of clips
with predicted
diagnostic
quality

Auto-Capture: The
Caption Guidance Auto-
Capture feature triggers
an automatic capture of a
clip when the quality is
predicted to be diagnostic,
emulating the way in
which a sonographer
knows when an image is
of sufficient quality to be
diagnostic and records it.

Substantially Equivalent:
This feature is not
provided; the UltraSight
software provides to the
user the view detection
and quality bar features
which enable any user to
clearly identify when a
diagnostic quality image
has been achieved and to
manually save the clip.

Retrospectively
recording of
highest quality
clip

Save Best Clip: This
feature continually
assesses clip quality while
the user is scanning and,
in the event that the user
is not able to obtain a clip
sufficient for Auto-
Capture, the software
allows the user to
retrospectively record the
highest quality clip
obtained so far, mimicking
the choice a sonographer
might make when
recording an exam.

Substantially Equivalent:
Although this feature is not
provided, the
UltraSight software
provides to the user the
view detection and quality
bar features which enable
any user to clearly identify
when a diagnostic quality
has been achieved and to
manually save the clip.

UltraSight Ltd. SECTION 5 SUMMARY Page: 5-6 of 10


Performance test for View
Detection and Guidance tests

Table 1: Data used for Algorithm Development and Performance Testing


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

IEC60601-1-2: 2020-09(4.1 Edition) , Medical electrical equipment - Part
1-2: General requirements for basic safety and essential performance -
EMC

IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment – Part 2-
37: Particular requirements for the basic safety and essential performance


of ultrasonic medical diagnostic and monitoring equipment

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

ISO 14971:2019, Medical devices - Application of risk management to
medical devices

NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment Revision 3


Validation Type
Definition
Acceptance Criteria

Number of correctly detected frames
×100
Total number of frames with nerve

1000
Average latency time of each frame (msec)


Validation Type
Average
Standard Deviation
95% CI

Summary Performance data, Standard Deviations & Confidence Intervals:


Imbio RV/LV Software
K203256 - Predicate Device

The Imbio RV/LV Software
device is designed to measure
the maximal diameters of the
right and left ventricles of the
heart from a volumetric CTPA
acquisition and report the ratio
of those measurements. RV/LV
analyzes cases using an artificial
intelligence algorithm to
identify the location and
measurements of the ventricles.
The RV/LV software provides
the user with annotated images
showing ventricular
measurements. Its results are
not intended to be used on a
stand-alone basis for clinical
decision-making or otherwise
preclude clinical assessment of
CTPA cases.

The Rapid RV/LV software
device is designed to measure the
maximal diameters of the right
and left ventricles of the heart
from a volumetric CTPA
acquisition and report the ratio of
those measurements for adults.
Rapid RV/LV analyzes cases
using machine learning
algorithms to identify locations
and measurements of the
ventricles. The Rapid RV/LV
device provides the user with
annotated images showing
ventricular measurements. Its
results are not intended to be used
on a stand-alone basis for clinical
decision-making or otherwise
preclude clinical assessment of
CTPA cases.


GE Medical Systems SCS
Establishment Registration Number - 9611343
283 rue de la Miniere
78530 Buc, France

Yonghui Han
Senior Regulatory Affairs Leader
GE HealthCare
(+1) (262)225-1914
Yonghui.Han@ge.com

Elizabeth Mathew
Senior Regulatory Affairs Manager
GE HealthCare
Tel: (+1) (262)424-7774
Email: Elizabeth.Mathew@ge.com

Primary Regulation Number:
Primary Product Code:
Secondary Product Code:
Classification:

Computed Tomography X-Ray System (21 CFR 892.1750)
JAK
QIH
Class II

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


CT Spine Labeling
algorithm
(Vertebrae
Detection and
Vertebrae Labels)


Disc Detection
algorithm
(Disc Position, Disc
Orientation & Disc
Labels)

Substantially
Equivalent.
Spine Auto Views
introduces a new deep
learning Disc detection
algorithm which can
detect discs positions,
planes/orientations
and generate disc
labels.

Traditional reformat
orientations (axial, coronal,
sagittal)

Curved coronal and curved
sagittal views of the spine
as well as oblique axial
views perpendicular to the
3D curved trace.

Curved coronal and curved sagittal
views of the spine as well as oblique
axial views through the
intervertebral spaces.

Substantially
Equivalent
Both the subject device
and predicate device
can output curved
coronal and curved
sagittal views and
oblique axial view.
However, the
methodology in which
these reformat series
are generated are
different between the
subject device and
predicate device.
For the curved
reformats, Bone VCAR
uses the centerline
traced through the
vertebrae centers;
Spine Auto Views use
the centerline traced
through the posterior

510(k) Premarket Notification Submission -Spine Auto Views


edge of the disc
centers.
For oblique axial views
generation, the oblique
axial of Bone VCAR is
perpendicular to its
centerline. Spine Auto
Views uses the
computed position and
orientation of the discs.

Bone VCAR uses input
volume field of view and
manually adjusted by the
user.

Spine Auto Views uses input volume
field of view and additionally has an
option to automatically set the field
of view to focus on the spine

Substantially
Equivalent
The subject device has
two configurations:
input series field of
view, or automated
field of view focused
on the spine.

Substantially
Equivalent
In the subject device,
all generated series can
be automatically
exported to DICOM
destinations, such as
PACS, ready for review
and interpretation.

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

Subject device doesn't
have a user interface
and doesn't include
measurement tools.
Subject device provides
DICOM reformat
images for export.


ECHELON OVAL V6.0A (K172110)
ECHELON Synergy

Super-conducting magnet, horizontal bore,
1.5 Tesla

Bore dimension
Oval shape with 74cm x 65cm
Circle shape with diameter 70cm

Rise Time
227μsec to 34mT/m
254μsec to 33mT/m

Duty Cycle
100% (Gating max), 12.5% at full power
85% (Gating max), 10% at full power


☐ Manufacturing Process
☐ Labeling
☐Technology


WIT Posterior Head/Neck coil, WIT Anterior
Head attachment
WIT Posterior Head/Neck coil B

WIT Torso coil
WIT Torso coil 12
WIT Torso coil 8

FlexFit Blanket Coil A,
FlexFit Blanket Coil B

WIT Anterior Neck attachment
WIT Anterior Neck attachment B


WIT Spine coil 12
WIT Spine coil A
WIT Spine coil 8
WIT Spine coil B

Flexible Extremity coil (Long Bone)
Flex M coil, Flex S Coil


・ Breast Support Kit 2 is available for Breast Coil as the accessories.


Operating System
Going from Windows 7 to Windows 10 IoT
See Table 6

Xeon E3-1275 v6 3.8GHz, Xeon Silver 4210 2CPU, Core i5-7440EQ

Application Software
Going from V6.0A to V9.0A
See Table 6

Following positioning application of Scan Tasks are added in Auto Pose.

Add the parameter R1 in Parameter Analysis

Following 3D Processing Tasks are added.


Following protocol enhancement are added.

- Dynamic slice count per study changes 4096 to 200.

- 2D opFSE, 2D opFIR, 2D/3D Prime FSE and 2D/3D Prime FIR are integrated to FSE or FIR in

- 3D Soft RSSG and 3D Soft RSSG EPI are added in “Soft Sound” category.

Pulse Sequences
Following Pulse sequence are added.

- 3D RF Spoiled SARGE Echo Planar Imaging (3D Soft RSSG EPI)

- 2D Phase Sensitive Inversion Recovery (2D PSIR)

- 2D IR sequence is integrated to SE using with IR-pulse.

- 2D opFSE, 2D opFIR, 2D/3D Prime FSE and 2D/3D Prime FIR are integrated to FSE or FIR.

- 2D Time Reversed SARGE (2D TRSG) is not available.

- 3D Time Reversed SARGE (3D TRSG) is not available.

Following functions are added as powered by Machine Learning


☐Manufacturing Process
☐Labeling
☐Technology

- 2D Phase Sensitive Inversion Recovery (2D PSIR)


ECHELON OVAL
(1.5T MRI, FUJIFILM Healthcare Corporation)
ECHELON Smart
(1.5T MRI, FUJIFILM Healthcare Corporation)
ECHELON Synergy
(1.5T MRI, FUJIFILM Healthcare Corporation)

FUJIFILM Healthcare Corporation and clinical site

Subject type
Healthy volunteer and patient

Head, Spine, Cardiac, Breast, Abdomen, Pelvis,
Shoulder, Wrist, Knee, Ankle

The information about the data in the above evaluations is shown below.


ECHELON Synergy
(1.5T MRI, FUJIFILM Healthcare Corporation)

Data acquisition site
FUJIFILM Healthcare Corporation

Subject type
J apanese healthy volunteers


Subject type
Japanese heal thy volunteers

positioning. The information about the data in the above tests is shown below.


GE Healthcare (Tianjin) Company Limited
No. 266 Jingsan Road, Tianjin Airport Economic Area
Tianjin, P.R. China 300308

GE Medical Systems, LLC
3200 N Grandview BLVD. Waukesha, WI USA 53188

Huande Li
Regulatory Affairs Manager
GE Healthcare
Phone: 86-18101131237
E-mail: huande.li@ge.com

Glen Sabin
Director, Regulatory Affairs
GE Healthcare
Phone: 262- 5216848
E-mail: glen.sabin@ge.com

Magnetic Resonance Diagnostic Device per 21 CFR
892.1000

SIGNA™ Explorer (K143251)
SIGNA™ Prime (K211980)

SIGNA Voyager (K161567)
SIGNA Artist Evo (K213603)


SIGNA™ Victor is a whole body magnetic resonance scanner
designed to support high resolution, high signal-to-noise ratio, and
short scan time. The system uses a combination of time-varying
magnet fields (Gradients) and RF transmissions to obtain
information regarding the density and position of elements
exhibiting magnetic resonance. The system can image in the
sagittal, coronal, axial, oblique, and double oblique planes, using
various pulse sequences, imaging techniques and reconstruction
algorithms. The system features a 1.5T superconducting magnet
with 60cm bore size. The system is designed to conform to NEMA
DICOM standards (Digital Imaging and Communications in
Medicine).

The SIGNA Victor is a whole body magnetic resonance scanner
designed to support high resolution, high signal-to-noise ratio, and
short scan times. It is indicated for use as a diagnostic imaging
device to produce axial, sagittal, coronal, and oblique images,
spectroscopic images, parametric maps, and/or spectra, dynamic
images of the structures and/or functions of the entire body,
including, but not limited to, head, neck, TMJ, spine, breast, heart,
abdomen, pelvis, joints, prostate, blood vessels, and
musculoskeletal regions of the body.
Depending on the region of interest being imaged, contrast agents
may be used. The images produced by SIGNA Victor
reflect the spatial distribution or molecular environment of nuclei
exhibiting magnetic resonance.
These images and/or spectra when interpreted by a trained
physician yield information that may assist in diagnosis.

The SIGNA™ Victor employs the same fundamental scientific
technology as its predicate devices.
SIGNA™ Victor is built with superconducting magnet, RF transmit
architecture, RF receive chain and software application suite.


The changes in technology do not impact the indications for use.
The indications for use have not been changed, other than to
reflect the SIGNA™ Victor product name.
Therefore, the intended use is the same as the predicate devices
in accordance with the FDA’s guidance document “The 510(k)
Program: Evaluating Substantial Equivalence in Premarket
Notifications [510(k)]”, dated 28 July 2014.

Comparison of
Technological
Characteristics

Overall, the SIGNA™ Victor employs the same fundamental
scientific technology as the predicate devices.
System Design: Both SIGNA™ Victor and the predict devices
includes the 1.5T magnets, RF transmit architecture, RF receive
chain and software application suite.
Operating Principles: The SIGNA™ Victor functions using the
same operating principles as the predicate devices.
Materials: The SIGNA™ Victor and the predicate devices both
use flame retardant materials.
Safety and Performance Testing: Both the SIGNA™ Victor and
the predicate devices comply with the same safety and
performance testing (see Determination of Substantial
Equivalence, below).
These technological differences do not raise any different
questions regarding safety and effectiveness. Both devices must
address questions of whether they provide an adequate level of
image quality appropriate for diagnostic use. The performance
data described in this submission include results of both bench
testing and clinical testing that show the image quality
performance of SIGNA™ Victor compared to the predicate
devices.

Determination of
Substantial
Equivalence:

Summary of Non-Clinical Tests:
The SIGNA™ Victor and the predicate devices were subject to
similar risk management testing to demonstrate substantial
equivalence of safety and performance.


2016. The image quality of the SIGNA™ Victor is substantially
equivalent to that of the predicate devices.
Substantial Equivalence Conclusion:
The indications for use of the proposed device are comparable to
the claimed predicate devices. The SIGNA™ Victor employs
equivalent technology to the claimed predicate devices.
Additionally, the results from the above non-clinical tests
demonstrate that the device performs as intended. Therefore, the
SIGNA™ Victor is substantially equivalent to the predicate devices
to which it has been compared.

In conclusion, GE Healthcare considers the SIGNA™
Victor to be as safe, as effective, with performance that
is substantially equivalent to the predicate devices.


Philips Medical Systems Nederland B.V.
Veenpluis 6, 5684 PC, Best, The Netherlands
Establishment Registration Number: 3003768277

Primary Contact
Person:
Secondary Contact
Person

Susan Quick
Regulatory Affairs Manager
Telephone: (440) 869-4612
E-mail: susan.quick@philips.com
Jan van de Kerkhof
Associate Director Regulatory Affairs
Telephone: +31 613300542
E-mail: jan.van.de.kerkhof@philips.com

Device Name:
MR 5300 and MR 7700 R11 MR Systems

Magnetic Resonance Diagnostic Device
(MRDD)

Achieva, Ingenia, Ingneia CX, Ingenia Elition,
And Ingenia Ambition MR Systems R11

Manufacturer:
Philips Medical Systems Nederland B.V.

Ingenia 3.0T, Ingenia 3.0T CX, Ingenia
Elition, and MR 7700 with distributed Multi
Nuclei


In this 510(k) submission, Philips Medical Systems Nederland B.V. will
be addressing the following minor software enhancements to the
proposed MR 5300 and MR 7700 R11 MR Systems when compared
to the legally marketed primary predicate, Achieva, Ingenia, Ingenia
CX, Ingenia Elition and Ingenia Ambition MR Systems R11
(K213583, 05/16/2022) and the secondary predicate devices Ingenia
3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with
distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300
(K212673, 11/19/2021):
1. SmartSpeed AI
2. SmartSpeed MotionFree
3. SmartSpeed 3D FreeBreathing
4. SmartSpeed Implant
5. SmartSpeed DWI
6. MR Workspace
7. ISP MR Packages
8. MR Elastography (MR 5300 only)
This 510(k) submission will also address the following minor hardware
enhancements:
1. Introduction of a graphical processing unit in the host recon
computer for image reconstruction
2. Additional monitor as part of the operating console
The supporting documentation provided for the proposed MR 5300 and
MR 7700 R11 MR Systems, includes software and hardware
modifications that are addressed in test reports for system level
development project, Voyager R11.1.
The proposed MR 5300 and MR 7700 R11 MR Systems are intended
to be marketed with the following pulse sequences and coils that are
previously cleared by FDA:
1. mDIXON (K102344)
2. SWIp (K131241)
3. mDIXON-Quant (K133526)
4. MRE (K140666)
5. mDIXON XD (K143128)
6. O-MAR (K143253)
7. 3D APT (K172920)
8. Compatible System Coils

There are no changes to the indications for use statement, provided
below, of the proposed MR 5300 and MR 7700 R11 MR Systems
when compared to the primary predicate Achieva, Ingenia, Ingenia CX,
Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583,
05/16/2022).
Philips Magnetic Resonance (MR) systems are Medical Electrical
Systems indicated for use as a diagnostic device.


This MR system enables trained physicians to obtain cross-sectional
images, spectroscopic images and/or spectra of the internal structure
of the head, body or extremities, in any orientation, representing the
spatial distribution of protons or other nuclei with spin.
Image appearance is determined by many different physical properties
of the tissue and the anatomy, the MR scan technique applied, and
presence of contrast agents.
The use of contrast agents for diagnostic imaging applications should
be performed consistent with the approved labeling for the contrast
agent.
The trained clinical user can adjust the MR scan parameters to
customize image appearance, accelerate image acquisition, and
synchronize with the patient’s breathing or cardiac cycle. The systems
can use combinations of images to produce physical parameters, and
related derived images. Images, spectra, and measurements of
physical parameters, when interpreted by a trained physician, provide
information that may assist diagnosis and therapy planning. The
accuracy of determined physical parameters depends on system and
scan parameters and must be controlled and validated by the clinical
user.
In addition, the Philips MR systems provide imaging capabilities, such
as MR fluoroscopy, to guide and evaluate interventional and minimally
invasive procedures in the head, body and extremities. MR
Interventional procedures, performed inside or adjacent to the Philips
MR system, must be performed with MR Conditional or MR Safe
instrumentation as selected and evaluated by the clinical user for use
with the specific MR system configuration in the hospital. The
appropriateness and use of information from a Philips MR system for a
specific interventional procedure and specific MR system configuration
must be validated by the clinical user.

Design Features/
Fundamental
Scientific
Technology:

The proposed MR 5300 and MR 7700 R11 MR Systems are based on
the principle that certain atomic nuclei present in the human body will
emit a weak relaxation signal when placed in a strong magnetic field
and excited by a radio signal at the precession frequency. The emitted
relaxation signals are analyzed by the system and a computed image
reconstruction is displayed on a video screen.
The principal technological components (magnet, transmit body coil,
gradient coil, gradient amplifier, RF amplifier and patient support) of the
proposed MR 5300 and MR 7700 R11 MR Systems are identical to
those used in the legally marketed primary predicate, Achieva,
Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR
Systems R11 (K213583, 05/16/2022) and the secondary predicate
devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700


with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300
(K212673, 11/19/2021).
The software R11 used on the proposed MR 5300 and MR 7700 R11
MR Systems is previously cleared on the legally marketed primary
predicate, Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia
Ambition MR Systems R11 (K213583, 05/16/2022).

Summary of Non-
Clinical
Performance Data:

The proposed MR 5300 and MR 7700 R11 MR Systems are in
compliance with the following international and FDA-recognized
consensus standards:
• IEC60601-1 Edition 3
• IEC60601-1-2 Edition 4
• IEC60601-1-6 Edition 3
• IEC62366-1 Edition 1
• IEC60601-1-8 Edition 2
• IEC60601-2-33 Edition 3
• IEC 62304 Edition 1
• NEMA MS-1 2008
• NEMA MS-4 2010
• NEMA MS-8 2008
• NEMA PS 3.1-PS 3.20
• ISO 14971 Edition 2
• Device specific guidance document, entitled “Guidance for the
Submission Of Premarket Notifications for Magnetic Resonance
Diagnostic Devices” (issued November 18, 2016 – document
number 340)
• Guidance for Industry and FDA Staff – Guidance for the
Content of Premarket Submissions for Software Contained in
Medical Devices (issued May 11, 2005 – document number
337)
• Guidance for Industry and FDA Staff – Content of Premarket
Submissions for Management of Cybersecurity in Medical
Devices (issued October 2, 2014 – document number 1825)
• Guidance for Industry and FDA Staff – Applying Human Factors
and Usability Engineering to Medical Devices (issued February
3, 2016 – document number 1757)
• Guidance for Industry and FDA Staff – Use of International
Standard ISO 10993-1, “Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk
management process” (issued June 16, 2016 – document
number 1811)
• Guidance for Industry and FDA Staff – Information to Support a
Claim of Electromagnetic Compatibility (EMC) of Electrically-
Powered Medical Devices (issued July 11, 2016 – document
number 1400057)
• Guidance for Industry and FDA Staff – Design Considerations
and Premarket Submission Recommendations for Interoperable
Medical Devices (issued September 6, 2017 – document
number 1500015)


Non-Clinical verification and or validation tests have been performed
with regards to the intended use, the technical claims, the requirement
specifications and the risk management results.
The verification and/or validation test results demonstrate that the
proposed MR 5300 and MR 7700 R11 MR Systems meet the
acceptance criteria and are adequate for the intended use.
Additionally, the risk management activities show that all risks are
sufficiently mitigated; that new risks that were identified are mitigated to
an acceptable level; and that the overall residual risk is acceptable.
Therefore, the proposed MR 5300 and MR 7700 R11 MR Systems are
substantially equivalent to the legally marketed primary predicate,
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition
MR Systems R11 (K213583, 05/16/2022) and the secondary predicate
devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700
with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300
(K212673, 11/19/2021), in terms of safety and effectiveness.

The proposed Ingenia MR 5300 and MR 7700 R11 MR Systems did
not require a clinical study since substantial equivalence to the legally
marketed predicate device was proven with the verification/validation
testing.

The proposed MR 5300 and MR 7700 R11 MR Systems and the
legally marketed primary predicate, Achieva, Ingenia, Ingenia CX,
Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583,
05/16/2022) and the secondary predicate devices Ingenia 3.0T,
Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed
Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673,
11/19/2021) have the same indications for use with respect to the
following:
• Providing cross-sectional images based on the magnetic
resonance phenomenon
• Interpretation of the images is the responsibility of trained
physicians
• Images can be used for interventional and treatment planning
purposes
The proposed MR 5300 and MR 7700 R11 MR Systems are
substantially equivalent to the legally marketed primary predicate
device, Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia
Ambition MR Systems R11 (K213583, 05/16/2022) and the
secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia
Elition, and MR 7700 with distributed Multi Nuclei (K213516,
03/03/2022) and MR 5300 (K212673, 11/19/2021), in terms of design
features, fundamental scientific technology, indications for use, and
safety and effectiveness.
Additionally, substantial equivalence is demonstrated with non-clinical
performance (verification and validation) tests, which complied with the


Manufacturer
Device Name
Application No.

Viz.ai, Inc.
Viz ANEURYSM, Viz ANX
K213319


Viz AAA is a radiological computer-
assisted triage and notification
software device for analysis of CTA
images of the abdomen. The device
is intended to assist hospital
networks and vascular or
endovascular specialists in
workflow triage by flagging and
prioritizing studies with suspected
abdominal aortic aneurysms during
routine patient care.
Viz AAA uses an artificial
intelligence algorithm to analyze
images and highlight studies with
suspected abdominal aortic
aneurysms in a standalone
application for study list
prioritization or triage in parallel to
ongoing standard of care. The
device generates compressed
preview images that are meant for
informational purposes only and not
intended for diagnostic use. The
device does not alter the original
medical image and is not intended
to be used as a diagnostic device.
Analyzed images are available for
review through the standalone
application. When viewed through
the standalone application the
images are for informational
purposes only and not for
diagnostic use. The results of Viz
AAA, in conjunction with other
clinical information and professional
judgment, are to be used to assist
with triage/prioritization of medical
images. Vascular or endovascular
specialists who read the original
medical images are responsible for

Viz ANEURYSM (Viz ANX) is a
radiological computer-assisted triage
and notification software device for
analysis of CT images of the head. The
device is intended to assist hospital
networks and trained radiologists in
workflow triage by flagging and
prioritizing studies with suspected
aneurysms during routine patient care.
Viz ANEURYSM uses an artificial
intelligence algorithm to analyze
images and highlight studies with
suspected aneurysms in a standalone
application for study list prioritization or
triage in parallel to ongoing standard of
care. The device generates
compressed preview images that are
meant for informational purposes only
and not intended for diagnostic use.
The device does not alter the original
medical image and is not intended to
be used as a diagnostic device.
Analyzed images are available for
review through the standalone
application. When viewed through the
standalone application the images are
for informational purposes only and not
for diagnostic use. The results of Viz
ANEURYSM, in conjunction with other
clinical information and professional
judgment, are to be used to assist with
triage/prioritization of medical images.
Radiologists who read the original
medical images are responsible for the
diagnostic decision. Viz ANEURYSM is
limited to analysis of imaging data and
should not be used in-lieu of full patient
evaluation or relied upon to make or
confirm diagnosis.


the diagnostic decision. Viz AAA is
limited to analysis of imaging data
and should not be used in-lieu of full
patient evaluation or relied upon to
make or confirm diagnosis.
Viz AAA is limited to detecting
aneurysms at least 3 cm in
diameter. Viz AAA is intended to
identify infra-renal, fusiform
abdominal aortic aneurysms.

Viz ANEURYSM is limited to detecting
aneurysms at least 4mm in diameter.

Notification-only, highlighting for
prioritization and review.

Acquires medical image data from
DICOM compliant imaging devices
and modalities

Initial assessment; non-diagnostic
purposes

Results returned
in Standalone
Application


Table 1: Device Sensitivity and Specificity


Device Performance by Health Care System

Table 2: Performance Stratified by Health Care System (Clinical Site)


Age Group (years)
Sensitivity [95% CI]
Specificity [95% CI]


Sex
Sensitivity [95% CI]
Specificity [95% CI]


Table 5: Performance Stratified by Abdominal Aortic Aneurysm Location


Diameter Range (mm)
Sensitivity [95% CI]

Table 6: Performance Stratified by Abdominal Aortic Aneurysm Diameter


Table 7: Performance Stratified by Aneurysm Type


Manufacturer
Sensitivity [95% CI]
Specificity [95% CI]

Table 8: Performance Stratified by CT Scanner Manufacturer


Device Performance by Manufacturer and Model

Manufacturer
Model
Sensitivity [95% CI]
Specificity [95% CI]

Table 9: Performance Stratified by CT Scanner Manufacturer and Model


Device Performance by Scanner Detector Rows

Detector Rows
Sensitivity [95% CI]
Specificity [95% CI]

Table 10: Performance by CT Scanner Row Detectors


Slice Thickness
Sensitivity [95% CI]
Specificity [95% CI]

Table 11: Performance by Slice Thickness


Table 12: Performance by Imaging Protocol


Presence of Metal Artifact
Sensitivity (95% C.I.)
Specificity (95% C.I.)

Metal is present, not obscuring the aorta

Metal is present obscuring the aorta
0.67 [0.22, 0.96]
0.93 [0.66, 1.00]

Table 13: Performance by Presence of Metal Artifact


Philips Medical Systems Nederland B.V.
Veenpluis 6, 5684 PC, Best, The Netherlands
Establishment Registration Number: 3003768277

Primary Contact
Person:
Secondary Contact
Person

Ioana Ulea
Senior Regulatory Affairs Specialist
Phone: +31 618345875
E-mail: ioana.ulea@philips.com
Jan van de Kerkhof
Associate Director Regulatory Affairs
Phone: +31 613300542
E-mail: jan.van.de.kerkhof@philips.com

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and
MR 7700 MR Systems

Magnetic Resonance Diagnostic Device
(MRDD)

Achieva, Ingenia, Ingenia CX, Ingenia Elition,
and Ingenia Ambition MR Systems (R11)

Manufacturer:
Philips Medical Systems Nederland B.V.

Trade name:
MR 5300 and MR 7700 R11 MR Systems


the following pulse sequences and coils that are previously cleared by
FDA:
1. mDIXON (K102344)
2. SWIp (K131241)
3. mDIXON-Quant (K133526)
4. MRE (K140666)
5. mDIXON XD (K143128)
6. O-MAR (K143253)
7. 3D APT (K172920)
8. Compatible System Coils
The accessories to be used with the proposed device Ingenia, Ingenia
CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR
Systems have not changed compared to the primary predicate device and
secondary predicate device and can be found in the Instructions for Use
accompanying the device:
• System coils
• PPU Sensor for wireless physiology
• Pediatric PPU Sensor
• FlexTrak trolleys (FlexTrak / HA FlexTrak II)
• Acoustic Hood
• MR Elastography
When Philips MRI system is used in combination with the Philips MR-RT
or MR-OR solutions, the user is referred to the dedicated MR-RT and MR-
OR Instructions for Use for information on additional accessories that may
apply:
• Flextrak OR
• MR-RT CouchTop
• RT CouchTop XD

The indications for Use statement provided below for the proposed device
is identical to the one of the primary and secondary predicate devices. The
intended use is also not impacted by the introduction of Precise Image
feature.
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems
indicated for use as a diagnostic device.
This MR system enables trained physicians to obtain cross-sectional
images, spectroscopic images and/or spectra of the internal structure of
the head, body or extremities, in any orientation, representing the spatial
distribution of protons or other nuclei with spin.
Image appearance is determined by many different physical properties of
the tissue and the anatomy, the MR scan technique applied, and presence
of contrast agents.


The use of contrast agents for diagnostic imaging applications should be
performed consistent with the approved labeling for the contrast agent.
The trained clinical user can adjust the MR scan parameters to customize
image appearance, accelerate image acquisition, and synchronize with
the patient’s breathing or cardiac cycle. The systems can use
combinations of images to produce physical parameters, and related
derived images. Images, spectra, and measurements of physical
parameters, when interpreted by a trained physician, provide information
that may assist diagnosis and therapy planning. The accuracy of
determined physical parameters depends on system and scan parameters
and must be controlled and validated by the clinical user.
In addition, the Philips MR systems provide imaging capabilities, such as
MR fluoroscopy, to guide and evaluate interventional and minimally
invasive procedures in the head, body and extremities. MR Interventional
procedures, performed inside or adjacent to the Philips MR system, must
be performed with MR Conditional or MR Safe instrumentation as selected
and evaluated by the clinical user for use with the specific MR system
configuration in the hospital. The appropriateness and use of information
from a Philips MR system for a specific interventional procedure and
specific MR system configuration must be validated by the clinical user.

Design Features/
Fundamental
Scientific
Technology:

Just as the primary and secondary predicate devices, the proposed
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and
MR 7700 MR Systems are based on the principle that certain atomic
nuclei present in the human body will emit a weak relaxation signal when
placed in a strong magnetic field and excited by a radio signal at the
precession frequency. The emitted relaxation signals are analyzed by the
system and a computed image reconstruction is displayed on a video
screen.
The principal technological components (magnet, transmit body coil,
gradient coil, gradient amplifier, RF amplifier and patient support) of the
proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR
5300 and MR 7700 MR Systems are unchanged compared to primary
predicate (K213583) and the secondary predicate device (K223442).
The reconstruction software of the proposed Ingenia, Ingenia CX,
Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
has been modified to include the Precise Image, offering an alternative to
the current way of increasing resolution, available on the primary and
secondary predicate devices. The resulting images can have higher SNR,
increased sharpness and decreased ringing artefacts compared to
primary and secondary predicate devices. The user interface provides
operators of the system with new options for selecting Precise Image
feature and adjusting the associated level of image noise reduction.


Medical electrical equipment - Part
2-33: Particular requirements for the
basic safety and essential
performance of magnetic
resonance equipment for medical
diagnosis

Medical Electrical Equipment -
Part 1: General Requirements
For Basic Safety And Essential
Performance (IEC 60601-1:2006,
MOD).

Medical electrical equipment - Part
1-2: General requirements for basic
safety and essential performance -
Collateral standard:
Electromagnetic disturbances -
Requirements and tests

Medical electrical equipment - Part
1-6: General requirements for basic
safety and essential performance -
Collateral Standard: Usability

Medical electrical equipment - Part
1-8: General requirements for basic
safety and essential performance -
Collateral Standard: General
requirements, tests and guidance
for alarm systems in medical
electrical equipment and medical
electrical systems

Medical devices – Application of risk
management to medical devices.

Medical devices – Part 1:
Application of usability engineering
to medical devices

Medical device software – Software
life cycle processes.


review, reproducibility of Precise in comparison to predicate device
reconstruction technique can be considered established. Additionally, a
reader evaluation by ABR board certified radiologists was performed,
where following properties have been analyzed as part of the comparison:
signal-to-noise ratio (SNR), artifact level, sharpness, and contrast-to-noise
ratio (CNR). Furthermore, the radiologists have assessed the quality of the
visualization of abnormalities and pathologies in case they were present
in the images as well as if the images were of sufficient quality for
diagnostic purposes. The review evaluation shows that the proposed
device is assessed as equivalent for diagnosis and holds significantly
better SNR and sharpness compared to the predicate reconstruction
technology, also in the presence of (subtle) abnormalities and pathology.
The verification and/or validation test results demonstrate that the
proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR
5300 and MR 7700 MR Systems meet the acceptance criteria and are
adequate for the intended use.
The risk management activities show that all risks are sufficiently
mitigated, that no new risks are introduced, and that the overall residual
risks are acceptable.
Therefore, the proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia
Ambition, MR 5300 and MR 7700 MR Systems are substantially
equivalent to the legally marketed primary predicate device Achieva,
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
(R11) (K213583, 16/05/2022) and the secondary predicate device MR
5300 and MR 7700 R11 MR Systems (K223442) in terms of safety and
effectiveness.

With the proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia
Ambition, MR 5300 and MR 7700 MR Systems the indications for use
remain unchanged and there were no technological characteristics relative
to the primary and secondary predicate device that would require clinical
testing.

The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition,
MR 5300 and MR 7700 MR Systems and the legally marketed primary
predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition, and
Ingenia Ambition MR Systems (R11) (K213583, 16/05/2022) and the
secondary predicate device MR 5300 and MR 7700 R11 MR Systems
(K223442), have the same indications for use with respect to the following:
• Providing cross-sectional images based on the magnetic resonance
phenomenon
• Interpretation of the images is the responsibility of trained physicians
• Images can be used for interventional and treatment planning
purposes
The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition,
MR 5300 and MR 7700 MR Systems are substantially equivalent to the
legally marketed primary predicate device Achieva, Ingenia, Ingenia CX,
Ingenia Elition, and Ingenia Ambition MR Systems (R11) (K213583) and
the secondary predicate device MR 5300 and MR 7700 R11 MR Systems


DHT8B: Division of Radiological Imaging Devices

Office of Product Evaluation and Quality


GE Medical Systems SCS
Establishment Registration Number - 9611343
283, rue de la Minière
78530 Buc, France

Ning WEN
Regulatory Affairs Program Manager Associate
GE HealthCare, (GE Medical Systems SCS)
Tel: +33 6 2324 6023
Email: ning.wen@ge.com

Rachel Schandel
Senior Regulatory Affairs Leader
Tel: +1 385 237 7519
Email: rachel.schandel@ge.com

Device Trade Name:
Common/Usual Name:
Regulation Number:
Product Code:
Regulatory Class:

FlightPlan for Embolization
FlightPlan for Embolization, with AI Segmentation option
21CFR 892.2050, Medical image management and processing system
QIH
Class II

Predicate Device:
Device Name:
Manufacturer:
510(k) number:
Regulation Number:
Product Code:
Regulatory Class:

FlightPlan for Embolization
GE Medical Systems SCS
K193261
21CFR 892.2050, Medical image management and processing system
LLZ
Class II

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


Specification
Predicate Device:
Proposed Device:

FlightPlan for Embolization
FlightPlan for Embolization

No limitations on the patient
population.

AI Segmentation option is validated
for adult population only.

Semi-automatic segmentation
of vasculature

No, segmentation of
vasculature can only be done
semi-automatically

Yes, automatic segmentation of
vasculature powered by Deep-
Learning based algorithm

No, definition of the root
point can only be done
manually

Yes, automatic definition of the
root point powered by Deep-
Learning based on algorithm

Selective display (Live Tracking)
Identical
Identical

the predicate device and the proposed device:


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

Chris Paulik
Senior Regulatory Affairs Manager
GE HealthCare
262-894-5415
Christopher.A.Paulik@ge.com

Gregory Pessato
Regulatory Affairs Director
GE HealthCare
+33 (6) 34423240
GregoryPessato@ge.com

Critical Care Suite with Pneumothorax Detection AI Algorithm

Regulation Name: Radiological computer assisted detection and diagnosis software
Regulation: 21 CFR 892.2090
Classification: Class II
Product Codes: QBS

BoneView (K212365)
Regulation Name: Radiological computer assisted detection and diagnosis software
Regulation: 21 CFR 892.2090
Classification: Class II

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


Critical Care Suite (K183182)
Regulation Name: Radiological computer aided triage and notification software
Regulation: 21 CFR 892.2080
Classification: Class II
Product Codes: QFM

Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal
chest X-rays acquired on a digital x-ray system for the presence of critical findings.
Critical Care Suite with Pneumothorax Detection AI Algorithm is indicated for adults and
transitional adolescents (18 to <22 years old but treated like adults) and is intended to
be used by licensed qualified healthcare professionals (HCPs) trained to independently
assess the presence of pneumothoraxes in radiographic images and radiologists. Critical
Care Suite is a software module that can be deployed on several computing platforms
such as PACS, On Premise, On Cloud or X-ray Imaging Systems.
Today’s clinical workflow, hospitals are overburdened by large volume of orders and long
turnaround times for radiologist reports. Critical Care Suite with the Pneumothorax
Detection AI Algorithm enables effective prioritization and assists in the detection /
diagnosis of pneumothoraxes for radiologists and HCPs that have been trained to
independently assess the presence of pneumothoraxes in radiographic images. It
performs this task by flagging images with a suspicious finding and providing a
localization overlay of the suspected pneumothorax as well as a graphical representation
of the algorithm’s confidence in the resultant finding. These outputs can be displayed
wherever the reviewing physician normally conducts their reads per their standard of
care, including PACS, On Premise, On Cloud and Digital Projection Radiographic Systems.

Critical Care Suite with Pneumothorax Detection AI Algorithm is intended to aide a
clinician in the detection and localization of a pneumothorax on frontal chest
radiographic images.

Critical Care Suite with Pneumothorax Detection AI Algorithm is a computer-aided triage,
notification, and diagnostic device that analyzes frontal chest X-ray images for the
presence of a pneumothorax. Critical Care Suite identifies and highlights images with a
pneumothorax to enable case prioritization or triage and assist as a concurrent reading
aid during interpretation of radiographs.
Intended users include qualified independently licensed healthcare professionals (HCPs)
trained to independently assess the presence of pneumothoraxes in radiographic images
and radiologists.
Critical Care Suite should not be used in-lieu of full patient evaluation or solely relied
upon to make or confirm a diagnosis. It is not intended to replace the review of the X-ray

510(k) Premarket Notification Submission


image by a qualified physician. Critical Care Suite is indicated for adults and Transitional
Adolescents (18 to <22 years old but treated like adults).

Critical Care Suite with Pneumothorax Detection AI Algorithm employs the same
fundamental scientific technology as its predicate and reference devices. They are all
deep learning locked AI algorithms that can be deployed on several computing platforms
such as PACS, On Premise, On Cloud or X-ray Imaging Systems. The patient and user
populations are equivalent to what was provided with Critical Care Suite with
Pneumothorax Detection AI Algorithm. The output is equivalent since both predicate
and proposed devices produce a result if a suspicious finding is detected, provide a
localization overlay of the suspected pathology within the image and a representation of
the algorithm’s confidence in the resultant finding. The intended use has been expanded
from the original release of Critical Care Suite (K183182) to display an overlay to the
reviewing physician that helps localize a detected pneumothorax. It also provides a
confidence level to the reviewing physician that provides contextual information in the
algorithm’s confidence for its pneumothorax detection output.
The differences between Critical Care Suite with Pneumothorax Detection AI Algorithm
and BoneView are the specific pathologies that are being detected. Critical Care Suite
with Pneumothorax Detection AI Algorithm analyzes frontal chest radiographic images
for the presence of a suspected pneumothorax where BoneView analyzes radiographic
images for the presence of suspected fractures. This difference does not impact the
safety or efficacy of Critical Care Suite with Pneumothorax Detection AI Algorithm since
both devices analyze images using deep learning AI technology to detect pathologies
producing an output that can aide clinicians and radiologists with their diagnosis.


Critical Care Suite with Pneumothorax
Detection AI Algorithm

Radiological computer assisted detection and
diagnosis software
Class II, QBS

Targeted clinical
condition,
anatomy, and
imaging modality

Pneumothorax
Chest/Lung
AP/PA Chest X-Ray Imaging

Fracture
Ankle, Foot, Knee, Femur, Wrist, Hand, Elbow,
Forearm, Humerus, Shoulder, Clavicle, Pelvis, Hip,
Ribs, Thoracic Spine, Lumbar Spine
2D Radiographic Images

AI deep learning algorithms designed to detect
pneumothorax in frontal chest X-ray images to aide
in identifying and highlighting pneumothoraxes
during the review of radiographs.

AI supervised deep learning algorithm designed to
aide in identifying and highlighting fractures during
the review of radiographs.

Critical Care Suite is designed as a self-contained
software module deployable on various
computational and x-ray imaging system platforms

Deployment on-premises or on cloud and connection
to several computing platforms and X-ray imaging

producing an output that can aide clinicians and radiologists with their diagnosis.


such as Digital Projection Radiographic Systems,
PACS, On Premise or On Cloud.

platforms such as X-ray radiographic systems, or
PACS

1. Configurable DICOM tag that identifies if a
suspected pneumothorax was detected.
2. Image annotations that contain:
 Flag if a suspected pneumothorax was
detected
 Graphical representation of the
algorithms confidence in the algorithms
result
 Overlay (color or grayscale) that localizes
the pneumothorax within the image

1. Optional Summary Table with the results of the
overall study
2. Results Image that contains
 Region of Interest that is a solid or dotted
rectangle based on confidence of the
algorithm
 Summary including the number of regions
of interest that are displayed and a caution
message if it was identified that the image
was not part of the indications for use of
BoneView.

Destination for
Viewing Algorithm
Results

Image annotation on a secondary DICOM image and
a DICOM message that identifies if a suspected
pneumothorax was detected within the study.
The output can be immediately used to visualize the
results on any DICOM destination such as a user’s
images storage system (PACS) or the x-ray system.

Image annotations made on copy of original image or
image annotations toggled on/off.
The output can be immediately used to visualize the
result on any DICOM destination such as a user’s
images storage system (PACS) or other radiological
equipment (X-Ray System)


clinical users who would interact with the Critical Care Suite with Pneumothorax
Detection AI Algorithm: radiologists (Rad.), internal medicine (IM) physicians, emergency
medicine (ER) physicians, and nurse practitioners. This study contained 400 images from
the original validation ground truth dataset used to determine the standalone
performance of the algorithm, and adequately analyzed that all the primary and
secondary endpoints met the defined passing criteria.
Critical Care Suite with Pneumothorax Detection AI Algorithm improved reader
performance for detection of pneumothorax, measured by mean AUC, by 14.5%
(7.0%,22.0%; p=.002), from 76.8% non-aided to 91.3% aided. Reader sensitivity
increased by 16.3% (13.1%, 19.5%; p<.001) from 67.4% non-aided to 83.7% aided.
Reader specificity increased by 12.4% (9.6%, 15.1%; p<.001) from 76.6% non-aided to
89.0% aided. The overall performance by size was also improved. The readers showed
an improvement for detection of large pneumothorax measured by mean AUC 10.5%
(3.2%, 17.8%, p=0.009) and sensitivity 13.4% (10.0%, 16.9%, p<.001). The readers
showed an improvement for detection of small pneumothorax measured by mean AUC
17.6% (9.3%, 25.9%, p<0.001) and sensitivity 18.7% (13.8%, 23.6%, p<.001). The
different clinical user’s improvements in mean AUC were assessed, and it was noted that
all physicians (Rad, IM, ER) improved 10.4% (2.8%, 17.9%, p=0.015), nurse practitioners
improved 24.1% (1.2%, 47.0%, p=0.045), radiologists improved 2.4% (-1.0%, 5.7%,
p=0.095), and non-radiologists (ER, IM, NP) improved 17.5% (9.6%, 25.4%, p<0.001).

Determination
of Substantial
Equivalence:

The introduction of Critical Care Suite with Pneumothorax Detection AI Algorithm does
not result in any new potential safety risks and uses the same fundamental deep learning
based technology to detect pathological finding on 2D X-ray images. Technological
differences were assessed through bench testing and clinical validation. Like its predicate
the device has been shown to improve intended user accuracy at detecting the targeted
pathological finding by licensed healthcare professionals, thus demonstrating that the
proposed device is substantially equivalent to its predicate.
After analyzing design verification and validation testing on the bench and the clinical
testing results it is the conclusion of GE HealthCare that the Critical Care Suite with
Pneumothorax Detection AI Algorithm software to be as safe, as effective, and
performance is substantially equivalent to the predicate device.


Feature
Subject device
Predicate device
Comparison
Impact to

ViewFinder is a
dedicated softcopy
review environment for
both screening and
diagnostic digital breast
tomosynthesis.
Its user interface and
workflow have been
optimized to support
qualified interpreting
physicians in both
screening and
diagnostic reading.
Efficiency and reading
quality are supported
by various specialized
features.
ViewFinder provides
visualization and image
enhancement tools to
aid a qualified
interpreting physician
in the review of digital
breast tomosynthesis
datasets. The qualified
interpreting physician
is responsible for

MAMMOVISTA B.smart
is a dedicated
softcopy review
environment for both
screening and
diagnostic
mammography as well
as digital breast
tomosynthesis.
Its user interface and
workflow have been
optimized to support
experienced
mammography and
tomosynthesis
reviewers in both
screening and
diagnostic reading.
Efficiency and reading
quality are supported
by various specialized
features.
MAMMOVISTA B.smart
provides visualization
and image
enhancement tools to
aid a qualified
radiologist in the
review of digital
mammography and
digital breast
tomosynthesis
datasets, as well as

Equivalent
The subject
device is more
explicit.
The predicate
device includes
multi-modality
images (e.g.,
MRI and
ultrasound).


making the diagnosis of
the images presented.

Display of 3rd
party
Computer
Aided
Diagnostics
(CAD) markers

MG Tomo
(Mammography
Tomosynthesis images)
DICOM DSR
(Deformable Spatial
Registration)

MG (Digital
Mammography X-Ray)
MG Tomo
(Mammography
Tomosynthesis images)
MR (Magnetic
Resonance)
US (Ultrasound)

The subject
has an
additional
conformant
modality
storing tissue
correlation.
The subject
omits MR and
US

ViewFinder’s
Deep Learning
improves
accuracy

The subject
device
excludes angle
measurements

Supported
Image
Generating
Manufacturers
and Models

Only DBTs produced on
Hologic’s Selenia
Dimensions and GE
Healthcare’s SenoClaire
and Senographe
Pristina

No restriction given for
manufacturer or
model.

The subject
device is
restricted to
fewer
manufacturers
and models. It
does not
process
combinations
which are out
of scope.


Standards Reference Number and
Title of Standard

Medical devices – application of risk management
to medical devices

Medical device software - Software life cycle
processes

Digital Imaging and Communications in Medicine
(DICOM) Set

Health software – Part 1: General requirements
for product safety


Frequency that ground truth is
inside oval (n)


The device does not alter the original medical image.

intended to be used as a standalone diagnostic device and shall not be used to make decisions with

diagnosis or therapeutic purposes. Patient management decisions should not solely be based on

Diffusion Perfusion Mismatch V1.0
results.


MR Diffusion Perfusion Mismatch V1.0
Olea Sphere® V3.0 (K152602)

Substantial equivalence comparison table


(Predicate Device, K121827)
(Proposed Device)

Automated - In the predicate device, the user
has to manually segment the bone region,
generate the MD images and fuse it/overlay
them onto the monochromatic base images,
and then export the output images as DICOM
secondary captures and send them to desired
DICOM destinations.
In the subject device, a fully automated
workflow generates the desired images
(colored MD images of the segmented bone
region overlaid on the monochromatic base or
Virtual Unenhanced images) as secondary
capture DICOM objects and networks them to
the preconfigured DICOM destinations (e.g.
PACS) for the user to review.
This change in the subject device greatly
improves the overall efficiency of the review
workflow.

CT Console, AW Workstation
(K110834), AW Server (K081985)

Algorithm Input
Dual energy DICOM images
Same

Dual energy images, including
monochromatic, Virtual
Unenhanced, and material
density images and has the
ability to output fused colored
material density (MD) images
(e.g Water (HAP)) of a
segmented bone region overlaid
on a monochromatic image as
secondary capture DICOM
series.

Fused image of colored material density (MD)
images (e.g water (HAP)) of the segmented
bone region overlaid onto the base
monochromatic spectral CT images or Virtual
Unenhanced images, as secondary capture
DICOM series.

510(k) Premarket Notification Submission – Spectral Bone Marrow


Trade/Device/ModelName
SYNAPSE 3D LUNGANDAB


KNumber
Manufacturer
ModelName
ProductCode
Regulation
Number

K223556
MEDICALIPCO., LTD.
DeepCatch
QIH
21CFR892.2050

K191026
MEDICALIPCO., LTD.
MEDIPPRO
LLZ
21CFR892.2050

K130542
FUJIFILMMEDICAL
SYSTEMU.S.A.,INC.
SYNAPSE 3D LUNGAND
ABDOMENANALYSIS
LLZ
21CFR892.2050

DeepCatch(cid:3) analyzes(cid:3) CT(cid:3)
images(cid:3)and(cid:3)auto-segments(cid:3)
anatomical(cid:3)structures(cid:3)(skin,(cid:3)
bone,(cid:3)muscle,(cid:3)visceral(cid:3)fat,(cid:3)
subcutaneous(cid:3) fat,(cid:3) internal(cid:3)
organs(cid:3)and(cid:3)central(cid:3)nervous(cid:3)
system).(cid:3) Then,(cid:3) its(cid:3) volume(cid:3)
and(cid:3) proportions(cid:3) are(cid:3)
calculated(cid:3)and(cid:3)provided(cid:3)with(cid:3)
the(cid:3)relevant(cid:3)3D(cid:3)model.
By(cid:3) using(cid:3) DeepCatch,(cid:3) it(cid:3) is(cid:3)
possible(cid:3)to(cid:3)obtain(cid:3)accurate(cid:3)
values(cid:3)for(cid:3)the(cid:3)volume(cid:3)and(cid:3)
proportion(cid:3) of(cid:3) each(cid:3)
anatomical(cid:3) structures(cid:3) by(cid:3)
secondary(cid:3)utilization(cid:3)of(cid:3)CT(cid:3)
images(cid:3)obtained(cid:3)for(cid:3)various(cid:3)
purposes(cid:3) in(cid:3) the(cid:3) medical(cid:3)
field.(cid:3)This(cid:3)device(cid:3)is(cid:3)intended(cid:3)
to(cid:3)be(cid:3)used(cid:3)in(cid:3)conjunction(cid:3)
with(cid:3) professional(cid:3) clinical(cid:3)
judgement.(cid:3) The(cid:3) type(cid:3) of(cid:3)
input(cid:3)data(cid:3)is(cid:3)whole(cid:3)body(cid:3)CT.(cid:3)
The(cid:3)physician(cid:3)is(cid:3)responsible(cid:3)
for(cid:3) inspecting(cid:3) and(cid:3)
confirming(cid:3)all(cid:3)results.

MEDIP PRO is intended for
use as a software interface
and image segmentation
system for the transfer of
DICOM imaging information
fromamedicalscannertoan
outputfile.Itisalsousedas
pre-operative software for
treatmentplanning.
The 3D printed models
generated from the output
file are meant for non-
diagnostic use. MEDIP PRO
should be used in
conjunction with other
diagnostic tools and expert
clinicaljudgement.

Synapse 3D Lung and
AbdomenAnalysisismedical
imaging software used with
Synapse 3D Base Tools that
is intended to provide
trained medical
professionals with tools to
aid them in reading,
interpreting, and treatment
planning. Synapse 3D Lung
and Abdomen Analysis
accepts DICOM compliant
medical images acquired
fromCT.
Thisproductis notintended
for use with or for the
primary diagnostic
interpretation of
Mammographyimages.
AdditiontoSynapse3DBase
Tools,Synapse3DLungand
Abdomen Analysis is
intendedto:
- use non-contrast and
contrast enhanced
computed tomographic
images of the lung, provide
custom workflows and UI,
and reporting functions for
lung analysis including
boundary detection and
volume calculation for
pulmonary nodules in the
lung based on the location
specified by the user,
segmentation of bronchial
tubes in the lung,
approximation of air supply
region by the user specified
bronchial tube, identifying,


Typeofuse
PrescriptionUse
Prescription Use
PrescriptionUse

Userpopulation Clinicalexpert Clinicalexpert Clinicalexpert

ImageModalities DICOMimaging DICOMimaging DICOMimaging

Feature/ -Analysis&Measurement -Analysis&Measurement -Analysis&Measurement

Functionality
-2D/3D visualization
-ImageEnhancement
-ImageEnhancement

-Segmentation
-2D/3D visualization
-2D/3D visualization

-3D Rendering
-Segmentation
-Segmentation

-ExportingCSVdata
-3D Rendering
-3D Rendering

-CalculationofBMI
-Exporting STLdatafor
-ExportReport

Segmentation Skin,Bone,Muscle, Skin,Bone,Muscle, Visceralfat,

Regions abdominalvisceralfat, abdominalvisceralfat, Subcutaneousfat

internalorgans, central
internalorgans, central

Item ProposedDevice PredicateDevice#1 PredicateDevice#2


Datasets Items Group Nullhypothesis Alternativehypothesis

Themeanofthewithin-
groupdifferenceis
greaterthan±10%
(0.10).


Themeanofthewithin-
groupdifferenceis
greaterthan±10%
(0.10).


Automated Radiological
Image Processing
Software (QIH)

System, Image
Processing, Radiological
(LLZ)

Anatomical Area
Joint (knee)
Joint (knee)
Joint (knee)

DICOM compliant images
in either digitally
computed (CR) or directly
digital (DX) formats

Knee detection;
Landmark detection; Joint
space detection

Intended User
Trained professionals
Trained professionals
Trained professionals

Web report with quality
warning, markup images
and editing interface

Markup images and
textual report as static
DICOM images

- Knee OA status:
KL grade ≥2 or ≤1
- JSN status:
Absent/Present
- Osteophyte status:
Absent/Present
- Sclerosis status:
Absent/Present
- Minimum Joint Space
Width
- Femoral-Tibial Angle

- Knee OA status:
KL grade ≥2 or <2
- JSN status:
Not present/Present
- Osteophyte status:
Not present/Present
- Sclerosis status:
Not present/Present
- Minimum Joint Space
Width


Black or African American
159 (14.2%)
626 (18.5%)

Unknown or not reported
12 (1.1%)
61 (1.9%)

Others (Not reported)
0 (0%)
1700 (9.2%)


DeepXray
Sample Number
Performance Metric
Result


DeepXray
Sample Number
Orthogonal linear regression
Result (95% C.I.)

measurements from the OAI study. The performance test results are summarized below:


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

Applicant Contact:
Mr. Ajit Shankaranarayanan

Applicant Contact Telephone:
(650) 397-8709

611 Gateway Blvd, Ste 120
South San Francisco, CA 94080 United States

Correspondent Contact:
Mr. Jared Seehafer

Medical image management and processing system

Classification Name:
System, Image Processing, Radiological

Predicate #: K203182
Predicate Trade Name: SubtleMR
Predicate Manufacturer: Subtle Medical, Inc.


Picture Archiving and Communications System


Characteristic
VisAble.IO
Aline Ablation Intelligence

Classification
Class II. 892.2050 QTZ, QIH, LLZ
Class II. 892.2050 LLZ

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


VisAble.IO is a Computed Tomography
(CT) image processing software
package available for use with liver
ablation procedures.
VisAble.IO is controlled by the user via a
user interface.
VisAble.IO imports images from CT
scanners and facility PACS systems for
display and processing during liver
ablation procedures.
VisAble.IO is used to assist physicians
in planning liver ablation procedures,
including identifying ablation targets and
virtual ablation needle placement.
VisAble.IO is used to assist physicians
in confirming ablation zones.
The software is not intended for
diagnosis. The software is not intended
to predict ablation volumes or predict
ablation success.

Aline Ablation Intelligence is a
Computed Tomography (CT) and
Magnetic Resonance (MR) image
processing software package available
for use with ablation procedures.
Aline Ablation Intelligence is controlled
by the user via a user interface on a
workstation.
Aline Ablation intelligence imports
images from CT and MR scanners and
facility PACS systems for display and
processing during ablation procedures.
Aline Ablation Intelligence is used to
assist physicians in planning ablation
procedures, including identifying
ablation targets and virtual ablation
needle placement. Aline Ablation
Intelligence is used to assist physicians
in confirming ablation zones.
The software is not intended for
diagnosis. The software is not intended
to predict ablation volumes or predict
ablation success.

The intended patient population is the
patient demographic chosen by
interventional radiologists to undergo
ablation treatment (including patient with
soft tissue lesions).

The application’s use environment is the
Operating Room and the hospital
healthcare environment such as
interventional radiology control room.

None – software only application. The
software application does not deliver or
depend on energy delivered to or from
patients


Window and level, pan, zoom, cross-
hairs, slice navigation

Tools for segmenting 3D VOIs, including
target tissues, ablation zones, vessels
and anatomy of the liver.

Tools for segmenting 3D VOIs, including
target tissues and ablation zones.

Registration of multiple images into a
single view.

Registration of multiple images and
imaging modalities into a single view.

Registration of the planning scan,
containing the identified target tissue,
with the confirmation scan showing the
ablation zone. The delineated target
tissue on the planning scan is then
projected onto the confirmation scan and
overlaid onto the delineated ablation
zone segmentation. This helps the user
in analyzing if the ablation zone covers
the target tissue with the desired amount
of margin.

Key images can be acquired which may
be saved locally.

Key images can be acquired which may
be saved back to PACS or any DICOM
nodes.


Algorithm
N
Gender
Mean
N per
CT Brand
Primary
Primary Endpoint


DHT8B: Division of Radiological Imaging Devices

Office of Product Evaluation and Quality


IBLabGmbH
Zehetnergasse6/2/2
1140Wien
Austria


IBLabKOALAisaradiological
fully-automatedimageprocessing
sowaredeviceofeithercomputed
(CR)ordirectlydigital(DX)images
intendedtoaidmedical
professionalsinthemeasurementof
minimumjointspacewidth;the
assessmentofthepresenceor
absenceofsclerosis,jointspace
narrowing,andosteophytesbased
OARSIcriteriafortheseparameters;
and,thepresenceorabsenceof
radiographickneeOAbasedon
Kellgren&LawrenceGradingof
standing,fixed-flexionradiographs
oftheknee.Itshouldnotbeused
in-lieuoffullpatientevaluationor
solelyreliedupontomakeor
confirmadiagnosis.Thesystemisto
beusedbytrainedprofessionals
including,butnotlimitedto,
radiologists,orthopedics,physicians
andmedicaltechnicians.

IBLabLAMAisafully-automated
radiologicalimageprocessingsoware
deviceintendedtoaidusersinthe
measurementoflimb-lengthdiscrepancy
andquantitativekneealignment
parametersonuni-andbilateralAPfullleg
radiographsofindividualsatleast22years
ofage.Itshouldnotbeusedin-lieuoffull
patientevaluationorsolelyrelieduponto
makeorconfirmadiagnosis.Thesoware
deviceisintendedtobeusedbyhealthcare
professionalstrainedinradiology.
IBLabLAMAisnotindicatedforuseon
radiographsonwhichAnkleArthroplasties
and/orUnicompartmentalKnee
Arthroplastiesarepresent.


DICOMcompliantimagescollected
inotherdevicesineitherdigitally
computed(CR)ordirectlydigital
(DX)formats

DICOMcompliantplainradiographs
collectedinotherdevices intheCR,DX,SC
formats.

1. UserorPACSsendsimage
todevice
2. Deviceperformsanalysis
3. ImageissentbacktoPACS
4. Userreviewsand
accepts/rejectsreport

1. UserorPACSsendsimageto
device
2. Deviceperformsanalysis
3. ImageissentbacktoPACS
4. Userreviewsandaccepts/rejects
report


1. Pre-processtheinputimage
2. Classifyuniorbilateral
image
3. Computeregionsofinterest
foreachside.
4. Detectlandmarksand
segmentations
5. Computedistances
6. ComputeOAparameters
7. Generatereports

1. Pre-processtheinputimage
2. Classifyuniorbilateralimage
3. Computeregionsofinterestfor
eachside.
4. Detectlandmarksand
segmentations
5. Computelinesanddistances
6. Computeangles
7. Generatereports

1. Same.
2. Same.
3. Same.
4. Same.
5. Similar.Thesubjectalsovisualizeslinesof
whichdistancesaremeasuredandthusraises
nonewquestionsregardingsafetyand
effectiveness.Standaloneperformancetesting
isperformedtoshowthatthesubjectdevice
performsasintended.SeeSection20:
PerformanceTesting-Clinical.
6. ThepredicatemeasuresOAparameters
(grades),whilethesubjectcomputesangles.
Standaloneperformancetestingisperformed
toshowthatthesubjectdeviceperformsas
intended.SeeSection20:Performance
Testing-Clinical.
7. Same

● Convolutionalneural
networksfor
○ classification
○ landmarking
○ segmentation
○ grading

● Convolutionalneuralnetworksfor
○ classification
○ landmarking
○ segmentation
● Classicalmethodsforcomputing:
○ auxiliarypoints
○ lengths

● Similar.Thetechnologyofthesubjectdevice
iscontainedinthepredicateandthusraises
nonewquestionsregardingsafetyand
effectiveness.Standaloneperformancetesting
isperformedtoshowthatthesubjectdevice
performsasintended.SeeSection20:
PerformanceTesting-Clinical


Regulation Number
21 CFR 892.2050
21 CFR 892.2050

Jazz is intended for the labeling,
visualization and volumetric
quantification of segmentable brain
structures from a set of MR images, for
patients with a known diagnosis of
multiple sclerosis (for the multiple
sclerosis pipeline) and/or brain
metastasis (for the metastasis pipeline),
and the production of a radiological
report.

icobrain is intended for automatic
labeling, visualization and volumetric
quantification of segmentable brain
structures from a set of MR or NCCT
images. This software is intended to
automate the current manual process of
identifying, labeling and quantifying the
volume of segmentable brain structures
identified on MR or NCCT images.
icobrain consists of two distinct image
processing pipelines: icobrain cross and
icobrain long.
• icobrain cross is intended to provide
volumes from MR or NCCT images
acquired at a single time point.
• icobrain long is intended to provide
changes in volumes between two MR
images that were acquired on the same
scanner, with the same image acquisition
protocol and with same contrast at two
different timepoints.
The results of icobrain cross cannot be
compared with the results of icobrain
long.


• This summary includes only information that is also covered in the body of the 510(k).

• This summary does not contain any puffery or unsubstantiated labeling claims.

• This summary does not contain any raw data, i.e., contains only summary data.

• This summary does not contain any trade secret or confidential commercial

• This summary does not contain any patient identification information.

safe and effective as the predicate, and does not raise different questions of safety and effectiveness.


Theproposeddevice,MOZI TreatmentPlanningSystem (MOZITPS), is astandalonesoftware

which is used to plan radiotherapy treatments (RT) for patients with malignant or benign

evaluation. Other functions include user login, graphical interface, system and patient


TheMOZITreatment
PlanningSystem(MOZI
TPS)isusedtoplan
radiotherapytreatments
forpatientswith
malignantorbenign
diseases.MOZITPSis
usedtoplanexternal
beamirradiationwith
photonbeams.

TheEclipseTreatment
PlanningSystem(Eclipse
TPS)isusedtoplan
radiotherapytreatments
forpatientswith
malignantorbenign
diseases.EclipseTPSis
usedtoplanexternal
beamirradiationwith
photon,electronand
protonbeams,aswellas
forinternalIrradiation
(brachytherapy)
treatments.
Inaddition,theEclipse
ProtonEyealgorithmis
specificallyindicatedfor
planning proton treatment
ofneoplasmsoftheeye.

Itisusedbyradiation
oncology department to
registermulti-modality
images and segment
(non-contrast)CT
images,togenerate
neededinformationfor
Treatmentplanning,
treatmentevaluationand
treatmentadaptation.

MIMsoftwareisusedbytrained
medicalprofessionalsasatooltoaid
inevaluationandInformation
managementofdigitalmedical
images.Themedicalimage
modalitiesinclude,butarenotlimited
to,CT,MRI,CR,DX,MG,US,
SPECT,PETandXAassupportedby
ACR/NEMADICOM3.0.MIM
assistsinthefollowingindications:
Receive,transmit,store,

retrieve,display,print,and
processmedicalimagesand
DICOMobjects.
Create,displayandprintreports

frommedicalimages.
Registration,fusiondisplay,and

reviewofmedicalimagesfor
diagnosis,treatmentevaluation,


andtreatmentplanning.
Evaluationofcardiacleft

ventricularfunctionand
perfusion.
Localizationanddefinitionof

objectssuchastumorsand
normaltissuesinmedical
images.

OperatingSystem Windows Windows Windows WindowsandMAC

Dosecalculationalgorithms MonteCarlo(photon) AAA、AXB N/A N/A

Autorigidregistrationalgorithms Intensitybased Intensitybased Intensitybased Intensitybased

Autodeformableregistrationalgorithms Intensitybased Intensitybased Intensitybased Intensitybased

Autosegmentationalgorithms Deeplearning Atlasbased Deeplearning Atlasbased

Multiple-instanceapplication Yes Yes N/A N/A

Multiple-workspacelayout Yes Yes N/A N/A

Dose-VolumeHistogramdisplay Yes Yes N/A N/A


(the device supports RT
Image/ RT Structure/ RT
Plan/RTDose)

CT/MRmanualimageregistration Yes Yes Yes Yes

Autorigidregistration Yes(IntensityBased) Yes(IntensityBased) Yes(IntensityBased) Yes(IntensityBased)

Autodeformableregistration Yes(IntensityBased) Yes(IntensityBased) Yes(IntensityBased) Yes(IntensityBased)

AutomaticCTsegmentationtool Yes(deeplearning) Yes(Atlasbased) Yes(deeplearning) Yes(Atlasbased)

ManualCTsegmentationtool Yes Yes Yes Yes


-DoseCalculation Yes(MonteCarlo) Yes(AAA、AXB) N/A N/A

Referencepointdosesummary Yes Yes N/A N/A

-Graphicswindowscreendump Yes Yes N/A N/A

-ContouringStructuralinformation Yes Yes N/A N/A

-Patientadministrationdata Yes Yes N/A N/A

-Geometricaldisplaysofplandata Yes Yes N/A N/A


Aquilion Precision
(TSX-304A/4) V10.10
with AiCE

JAK:
System, X-ray,
Tomography,
Computed


D
evice Name,
Aquilion Precision (TSX‐
Aquilion Precision (TSX‐

Model Number
304A/4) V10.14 with AiCE
304A/4) V10.10 with AiCE

• Magnified
reconstruction -
Available
magnification
Size (D-FOV)

BODY / BODY SHARP:
Min. 100 mm
LUNG:
Min. 100 mm
CARDIAC:
Min. 70 mm
Max. 500 mm

The minimum FOV
differs depending
on the anatomical
region.

• Reconstruction
processing
system [AiCE]
(CSAL-002A)

Option
[Reconstruction Processing
Unit required]

N/A
[AiCE implemented with
Reconstruction Processing
Unit (CCRS-003B)]

• BODY and BODY SHARP
(For Abdomen and
Pelvis)
• LUNG (For Chest)
• CARDIAC (For Cardiac)


Trade Name
BraveCX
Lunit INSIGHT CXR Triage

BraveCX is a radiological
computer-assisted triage and
notification software that analyzes
adult (≥18 years old) chest X-ray
images for the presence of pre-
specified suspected critical findings
(pleural effusion and/or
pneumothorax). BraveCX uses an
artificial intelligence algorithm to
analyze images for features
suggestive of critical findings and
provides case-level output available
in the PACS/workstation for
worklist prioritization or triage. As
a passive notification for
prioritization-only software tool
within standard of care workflow,
BraveCX does not send a proactive

Lunit INSIGHT CXR Triage is
a radiological computer-
assisted triage and notification
software that analyzes adult
chest X-ray images for the
presence of pre-specified
suspected critical findings
(pleural effusion and/or
pneumothorax). Lunit
INSIGHT CXR Triage uses an
artificial intelligence algorithm
to analyze images for features
suggestive of critical findings
and provides case-level output
available in the
PACS/workstation for worklist
prioritization or triage. As a
passive notification for

Table 5B – Comparison of Characteristics


alert directly to the appropriately
trained medical specialists.
BraveCX is not intended to direct
attention to specific portions of an
image or to anomalies other than
pleural effusion and/or
pneumothorax. Its results are not
intended to be used on a stand-
alone basis for clinical decision-
making.

prioritization-only software
tool within standard of care
workflow, Lunit INSIGHT
CXR Triage does not send a
proactive alert directly to the
appropriately trained medical
specialists. Lunit INSIGHT
CXR Triage is not intended to
direct attention to specific
portions of an image or to
anomalies other than pleural
effusion and/or pneumothorax.
Its results are not intended to
be used on a stand-alone basis
for clinical decision-making.

Notification-
only, parallel
workflow tool

Appropriately trained medical
specialists who are qualified to
interpret chest radiographs

Targeted
clinical
condition,
anatomy, and
modality

Pleural effusion, pneumothorax
Chest/Lung Frontal Chest X-ray

Pleural effusion, pneumothorax
Chest/Lung Frontal Chest X-
ray

Algorithm for
pre-specified
critical findings
detection

BraveCX is a Deep Learning
Artificial Intelligence (AI) software
that was trained to detect pleural
effusion and pneumothorax in chest
X-Ray images. BraveCX uses a
vendor agnostic algorithm
compatible with DICOM chest X-
Ray images

Lunit INSIGHT CXR is deep
learning based software that
assists radiologists or clinicians
in the interpretation of chest x-
ray. AI algorithm designed to
detect pleural effusion and
pneumothorax in chest X-ray
images. Lunit INSIGHT CXR
Triage uses a vendor agnostic
algorithm compatible with
DICOM chest X-ray images


BraveCX is supplied as a licensed
Application Programming Interface
(API) that can be deployed either as
a cloud-based service, directly on
premises, or integrated with third-
party systems.

Lunit INSIGHT CXR Triage is
designed as a software module
that can be deployed on several
computing and X-ray imaging
platforms such as radiological
imaging equipment, PACS, On
Premise or On Cloud.

Device output in
case of positive
detection

BraveCX automatically runs after
image acquisition.
The user may prioritize reporting
tasks by grouping images flagged by
BraveCX together. Results are
displayed through the worklist
interface of PACS/workstation
No markup on original image.
Secondary capture of the finding.
Upon image acquisition from other
radiological imaging equipment
(e.g. X-ray systems), an on-device,
technologist notification indicating
which cases were flagged in the
Secondary Capture image by Brave
CX in PACS, is generated 15
minutes after interpretation by the
user.
The on-device notification is
contextual and does not provide any
diagnostic information. It is not
intended to inform any clinical
decision, prioritization, or action to
the technologist.

Lunit INSIGHT CXR Triage
automatically runs after image
acquisition and prioritizes and
displays the analysis result
through the worklist interface
of PACS/workstation.
No markup on original image.
Secondary capture of the
finding.
Upon image acquisition from
other radiological imaging
equipment (e.g. X-ray systems),
an on-device, technologist
notification indicating which
cases were flagged in the
Secondary Capture image by
Lunit INSIGHT CXR Triage in
PACS, is generated 15 minutes
after interpretation by the user.
The on-device notification is
contextual and does not provide
any diagnostic information. It is
not intended to inform any
clinical decision, prioritization,
or action to the technologist.


Trade Name
BraveCX
Lunit INSIGHT CXR Triage

Notification
(i.e., recipient,
timing and
means of
notification)

Passive notification.
Images with suspicion are flagged
in PACS/workstation.

Where
generated
results (i.e.,
DICOM files)
are stored

Picture Archiving and
Communications (PACS) system or
some other local storage platform

Performance
level – Timing
of notification

The average time taken for the
notification to travel from the
BraveCX API to the point at which
the result is displayed in the
destination PACS/RIS/EPR
worklist is 10.4 seconds.

The average time taken for the
notification to travel from the
Lunit INSIGHT CXR Triage to
the point at which the result is
displayed in the destination
PACS/RIS/EPR worklist is
14.66 seconds.

Performance
level –
accuracy of
classification


Predicate Device K203290
Subject Device K223757

Information
(Bonelogic)
(Bonelogic 2.2)
Comparison

Medical image management
and processing system

Service Type
Software
Software
Identical

Classification
21 CFR 892.2050
21 CFR 892.2050
Identical

Bonelogic software is intended
to be used by specialized
medical practitioners to assist
in the characterization of
human anatomy with 3D
visualization and specific
measurements. The medical
image modalities intended to
be used in the software are
computed tomography (CT)
images, cone beam computed
tomography (CBCT) images
and weight-bearing cone beam
CT (WBCT) images. The
intended patient population is
adults over 16 years of age.
Bonelogic software contains
the measurement template

Bonelogic software is to be
used by orthopaedic healthcare
professionals for diagnosis and
surgical planning in a hospital
or clinic environment.
Bonelogic software provides:
Semi-automatic segmentation
with manual or assisted input
of bony structure identification
from CT imaging input,
Three-dimensional
mathematical models of the
anatomical structures of foot
and ankle,
Measurement templates
containing radiographic
measures of foot and ankle,
and tools for manually

Removal of wrist
and hand related
functionality and
addition of an
optional
semiautomatic
segmentation
workflow with
assisted bone
identification
process in the
subject device


with a set of distance and
angular measures. The
measurements can be used for
diagnostic purposes. The
three-dimensional (3D)
models are displayed and can
be manipulated in the
software. Together, the
information from the
measurements and the 3D
visualization can be used for
treatment planning in the field
of orthopedics (foot and ankle,
and hand and wrist). The 3D
models can be outputted from
the software for traditional or
additive manufacturing. The
physical models generated
based on the 3D digital models
are not intended for diagnostic
use.

obtaining linear and angular
measurements,
Surgical planning application
for foot and ankle using three-
dimensional models of the
anatomical structures and
radiographic measures.
The three-dimensional models
of the anatomical structures
combined with the
measurements can be used for
the diagnosis of orthopaedic
healthcare conditions. The
surgical planning application
containing the three-
dimensional structural models
combined with the
measurements can be used for
the planning of treatments and
operations to correct
orthopaedic healthcare
conditions of foot and ankle.

Computed tomography
DICOM Computed
tomography

Output
3D model of patient anatomy
3D model of patient anatomy
Identical

Perform measurements for
presurgical planning

Manual and an optional
semiautomatic workflow with
assisted input process
performed by artificial neural
network

Optional
semiautomatic
bone
identification
process in
subject device


Classification Name
21 CFR §
Product Code

System, imaging, pulsed doppler,
ultrasonic

System, imaging, pulsed echo,
ultrasonic

Transducer, ultrasonic, diagnostic
892.1570
ITX

Automated Radiological Image
Processing Software

Common Name: Diagnostic ultrasound system and transducers


There is no change to the intended use and indications for use of the subject device as compared to the

The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in

B(2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler, and M-modes.

It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:

Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small

Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung.

The Lumify system is a transportable ultrasound system intended for use in environments where

healthcare is provided by healthcare professionals.

The intended use of the product is to collect ultrasound image data that may be used by clinicians for

diagnostic and procedural purposes. The product shall provide the ability for gathering clinically

acceptable images and ultrasound data for the clinical presets and anatomies listed under the

This product is intended to be installed, used, and operated only in accordance with safety procedures

and operating instructions given in the product user information, and only for the purposes for which

it was designed. However, nothing stated in the user information reduces the user’s responsibility for

sound clinical judgement and best clinical procedure.


Standard Feature
Lumify Diagnostic Ultrasound
Lumify Diagnostic Ultrasound

System K223771 (Subject Device)
System K2030406 (Predicate Device)

Scientific Technology
Ultrasound Imaging
Ultrasound Imaging

Philips Lumify Diagnostic Ultrasound
System is intended for diagnostic
ultrasound imaging in B (2D), Pulsed
Wave, Color Doppler, Combined
(B+Color), and M modes.

Lumify Diagnostic Ultrasound
System is indicated for diagnostic
ultrasound imaging and fluid flow
analysis in the following applications:
Fetal/Obstetric, Abdominal, Pediatric,
Cephalic, Urology, Gynecological,
Cardiac Fetal Echo, Small Organ,
Musculoskeletal, Peripheral Vessel,
Carotid, Cardiac, Lung.
Lumify is a transportable ultrasound
system intended for use in
environments where healthcare is
provided by healthcare professionals.

B (2D), Pulse Wave, Color Doppler,
Combined (B+Color), and M modes

Secondary Product
IYO, ITX, QIH
IYO, ITX

Principles of Operation
(subject merged B-lines
Feature)

Automatic counting of B-lines and
detection of merged B-lines, with
optional manual adjustment of results
provided by the software.

Automatic counting of B-lines, with
optional manual adjustment of results
provided by the software.

Lumify Diagnostic Ultrasound System with Expanded B-lines Software Feature


Hispanic or Latino and Not Hispanic or Latino

The demographic distribution of the performance testing includes the following:


4.0.0 CT Model: Structure: MIM Atlas Contour ProtégéAI


4.0.0 CT Model:
Structure:
M
IM Atlas
Contour P
rotégé
A


Identifyandmarkregionsof
interest(ROIs)onchest
radiographsandlabelthebox
aroundtheROIasinterstitial
thickening

Identifyandmarkregionsof
interest(ROIs)onchest
radiographsandlabelthebox
aroundtheROIasoneofthe
following:Cardiac,
Mediastinum/Hila,Lungs,Pleura,
Bones,SoftTissues,Hardware,or
Other

Deviceintendedforuseasa
concurrentreadingaidfor
physiciansinterpretingchest
radiographs


BK3000 ULTRASOUND SYSTEM W/O
BATTERY
This configuration is primarily
intended for Urology and General
imaging applications.

BK3000 ULTRASOUND SYSTEM
W/BATTERY
This configuration is primarily
intended for Urology and General
imaging applications.

Table 1: Ultrasound System 2300 available configurations


BK5000 ULTRASOUND SYSTEM W/O
BATTERY
This configuration is primarily
intended for surgical applications.

BK5000 ULTRASOUND SYSTEM
W/BATTERY
This configuration is primarily
intended for surgical applications.

BKACTIV ULTRASOUND SYSTEM W/O
BATTERY
This configuration is primarily
intended for surgical,
anesthesiology, urology and
general imaging applications.


BKACTIV ULTRASOUND SYSTEM W/
BATTERY
This configuration is primarily
intended for surgical,
anesthesiology, urology and
general imaging applications.


5C1e (9085) CURVED ARRAY TRANSDUCER
X
X
X

6C2 (9040) CURVED ARRAY TRANSDUCER
X
X
X

6C2s (9023) SMALL CURVED ARRAY TRANSDUCER

9C2 (9002) CURVED ARRAY TRANSDUCER
X
X
X

14L3 (9051) LINEAR ARRAY TRANSDUCER
X
X
X

13L4w (9011) WIDE LINEAR ARRAY TRANSDUCER

10L2w (9022) WIDE LINEAR ARRAY TRANSDUCER

18L5 (9070) SMALL GIGH-FREQUENCY LINEAR ARRAY TRANSDUCER

18L5s (9081) SMALL GIGH-FREQUENCY LINEAR ARRAY TRANSDUCER

8L2 (9032) LINEAR ARRAY TRANSDUCER
X
X
X

E13C2 (9029) ENDFIRE ENDOCAVITY TRANSDUCER

E14C4t (9018) TRIPLANE ENDOCAVITY TRANSDUCER

X14CL4b (9048) BIPLANE ENDOCAVITY TRANSDUCER

E10C4 (9019) ENDOCAVITY TRANSDUCER
X
X
X

N13C5 (9062) CURVED ARRAY TRANSDUCER
X
X
X

5P1 (9077) PHASED ARRAY TRANSDUCER
X
X
X

X18L5S (9009) HOCKEY STICK TRANSDUCER
X
X
X

I14C5I (9015) INTRAOPERATIVE I-SHAPE TRANSDUCER

I14C5T (9016) INTRAOPERATIVE T-SHAPE TRANSDUCER

I12C5B (9024) INTRAOPERATIVE BIPLANE TRANSDUCER

I12C4f (9066) LAPAROSCOPIC TRANSDUCER
X
X

X14L4 (9038) 3D ENDOCAVITY TRANSDUCER
X
X

N20P6 (9007) MINIMALLY INVASIVE TRANSDUCER

I13C3f (9076)
ADVANCED LAPAROSCOPIC TRANSDUCER

I13C3fx (9078)
ADVANCED LAPAROSCOPIC TRANSDUCER WITH TRACKING

Table 2: Transducers used with Ultrasound System 2300 configurations


Ultrasound System 2300
Ultrasound System 2300

Manufacturer
BK Medical ApS
BK Medical A(KpS2 22441)
Same

Common Name
Ultrasound System
Ultrasound System
Same

B, M, PW, CFM, P, THI, CI, SE, CW
Combination modes:
2D+M, 2D+PW, 2D+C+PW,
2D+P+PW, 2D+2D, 2D+2D
(Biplane Imaging), 2D+(2D+C),
2D+(2D+P), 2D+THI, 2D+SE,
2D+CI

Intended Use:
The system is a diagnostic ultrasound
imaging system used by qualified
and trained healthcare professionals
for ultrasound imaging, human body
fluid flow analysis and puncture and
biopsy guidance.
Indications for Use:
The clinical applications and exam
types include:
• Fetal (including obstetrics)
• Abdominal
• Pediatric
• Intra-operative

predicate device
- Due to the new software upgrade v.
currently cleared clinical applications
Cardiac Adult,
Fetal (including obstetrics),
Trans-rectal,
Trans-vaginal,
Small Organ and
Peripheral vessel
with transducers (9077, 9048, 9038,
9052, 9018, 9019, 9029, 9027 and
9032) previously activated on bk5000

Table 3: Substantial Equivalence Table of the proposed device with its predicate devices


• Intra-operative Neuro (also
known as Neurosurgery)
• Laparoscopic
• Small Organ (also known as
Small Parts)
• Adult Cephalic (Cephalic is
also known as Adult Trans-
cranial)
• Neonatal Cephalic
• Trans-rectal
• Trans-vaginal
• Musculo-skeletal (Conventional
and Superficial)
• Cardiac Adult
• Trans-esophageal (Cardiac)
• Peripheral vessel (also known
as Peripheral Vascular)
Modes of operation:
• 2 D (B-Mode) including
Tissue Harmonic Imaging
• M-Mode
• PWD Mode
• CFM Mode (C, VFI)
• Power Doppler
• Contrast Imaging
• CW Doppler
Strain Elastography
Environment:
The Ultrasound System 2300 is
intended for use in the
professional healthcare
environment (e.g., hospitals,
physician offices).

• Intra-operat(iKve2 2N2e4u4r1o) ( also
known as Neurosurgery)
• Laparoscopic
• Small Organ (also known as
Small Parts)
• Adult Cephalic (Cephalic is
also known as Adult Trans-
cranial)
• Neonatal Cephalic
• Trans-rectal
• Trans-vaginal
• Musculo-skeletal (Conventional
and Superficial)
• Cardiac Adult
• Trans-esophageal (Cardiac)
• Peripheral vessel (also known
as Peripheral Vascular)
Modes of operation:
• 2 D (B-Mode) including
Tissue Harmonic Imaging
• M-Mode
• PWD Mode
• CFM Mode (C, VFI)
• Power Doppler
• Contrast Imaging
• CW Doppler
• Strain Elastography
Environment:
The Ultrasound System 2300 is
intended for use in the
professional healthcare
environment (e.g., hospitals,
physician offices).

/ bk3000 configurations will now also
be enabled on bkActiv configuration.


Contraindications
The Ultrasound System 2300 is not
intended for ophthalmic use or any use
causing the acoustic beam to pass
through the eye.
The Cardiac Adult application is not
intended for direct use on the heart.

Contraindica(tKio2n2s2 441)
The Ultrasound System 2300 is not
intended for ophthalmic use or any use
causing the acoustic beam to pass
through the eye.
The Cardiac Adult application is not
intended for direct use on the heart.

• Abdominal
• Intraoperative
• Intraoperative –
Neuro
(Neurosurgery)
• Pediatric
• Musculo-skeletal
Superficial &
Conventional
• Neonatal Cephalic
• Adult Cephalic (Trans-cranial)
• Laparoscopic
• Small Organ (Small Parts)
• Cardiac adult
• Transesophageal (Cardiac)
• Transrectal
• Transvaginal
• Fetal /Obstetrics
• Peripheral Vessel (Vascular)


Professional healthcare facility
environment

Users
Qualified Professional users
Qualified Professional users
Same

Patient Population
Adult, Pediatric
Adult, Pediatric
Same

Surface Contact
Intra-operative
Laparoscopic
Endocavity

Transducers 9077, 9048, 9038, 9052,
9018, 9019, 9029, 9027 and 9032
currently available with
bk5000/bk3000 configurations will be
enabled on bkActiv configurations to
support clinical applications Cardiac
Adult, Fetal (including obstetrics),
Trans-rectal, Trans-vaginal, Small
Organ (also known as Small Parts),
Peripheral vessel (also known as
Peripheral Vascular).


The Ultrasound System does not come
in contact with the patient.

Clinical display monitor (CDM):
• 19” Optical bonded glass front.
• Can be tilted and moved sideways.
Cart:
• adjustable height and with 4
lockable wheels
Keyboard:
Traditional keyboard with multiple
functionalities / specialized controls
or Glass touch UI
Scan engine:
• 4 Transducer ports
• 196 TX/RX channels
• Tracking Interface board

Same
No changes to hardware since last
clearance K222441.

UA1540 Tracking Control
Unit
UA1541 Portable EM Field
Generator (includes
field
generator and a
mounting solution)
UA1542 Clip-on needle
sensor
(CIVCO)
UA1543 Needle senor clamp
Kit (CIVCO)


Ultrasound System 2300
Ultrasound System 2300

Speckle reduction, compound
imaging, tissue harmonic imaging
(thi), contrast imaging (ci), trapezoid
scanning (virtual convex) strain,
elastography (se)

-19-inch Clinical Monitor and touch
input device
for user interaction.
-Trackball for cursor control.
-Touchpad track pad for cursor control
(Glass Touch UI)
-Full configurable interaction controls
(size/position)


Part of the test images
come from the Holland
dataset, which only
contributed to the test set.

• The table summarizes number of datasets used for each different purpose.


3mensio Workstation/3mensio
Structural Heart/3mensio Vascular

The predicate device to which substantial equivalence is claimed:


Subject device
Predicate device
Comparison

3mensio
Workstation/3mensio
Structural
Heart/3mensio Vascular

Regulation Number
21 CFR 892.2050
21 CFR 892.2050
same

Picture archiving and
communications system

Similar, the subject
device implements
artificial intelligence
including nonadaptive
machine learning
algorithms

FEops HEARTguide™
ALPACA enables
visualization and
measurement of
structures of the heart
and vessels for
preprocedural planning
and sizing of structural
heart interventions.

3mensio Workstation is
a software solution that
is intended to provide
Cardiologists,
Radiologists and
Clinical Specialists
additional information
to aid them in reading
and interpreting
DICOM compliant
medical images of

Same,
both the subject and
predicate device share
the same intended use,
in that they enable
visualization of medical
images of the heart, and
analysis of structures of
the heart and vessels.


FEops HEARTguide™
ALPACA is not
intended to replace the
implant device
instructions for use for
final LAAO and TAVI
device selection and
placement.

FEops HEARTguide™
ALPACA enables
visualization and
measurement of
structures of the heart
and vessels for
preprocedural planning
and sizing of structural
heart interventions.
To facilitate the above,
FEops HEARTguide™
ALPACA provides
general functionality
such as:
• Segmentation of
cardiovascular
structures
• Visualization and
image reconstruction
techniques: 2D review,
MPR
• Measurement and
annotation tools
• Reporting tools
FEops HEARTguide™
ALPACA also allows
visualization of output
generated by other
medical device software

3mensio Workstation
enables visualization
and measurement of
structure of the heart
and vessels for:
- Preoperational
planning and
sizing for
cardiovascular
interventions
and surgery
- Postoperative
evaluation
- Support of
clinical
diagnosis by
quantifying
dimensions in
coronary
arteries
- Support of
clinical
diagnosis by
quantifying
calcifications
(calcium
scoring) in the
coronary
arteries
To facilitate the above,
the 3mensio
Workstation provides
general functionality
such as:

Similar,
Both devices are
indicated to be used for
preprocedural planning
and sizing of structural
heart interventions.
Whereas the subject
device solely focuses on
preprocedural planning,
the predicate device
additionally includes
functionality for
postoperative
evaluation of structural
heart interventions. This
does not impact the
indication for use for
preprocedural planning.
The predicate device
also supports clinical
diagnosis by
quantifying
calcifications and
quantifying dimensions
in coronary arteries.
This functionality is not
present in the subject
device.


Landmark identification
and measurements

Both manual and AI
supported functions for
landmark identification.

Same, both devices are
limited to transcatheter
interventions.

Functionality for post-
intervention evaluation

The predicate device
includes functionality
for post-intervention
evaluation. This
functionality is absent in
the subject device.

Software verification
and validation was
performed.
Documentation is
provided as
recommended by
FDA’s Guidance for
Industry and FDA Staff
“Guidance for the
Content of Premarket
Submissions for
Software Contained in
Medical Devices”.
Design verification
confirmed that the
system requirements
were implemented
correctly.
Design validation
established that the
FEops HEARTguide
ALPACA conforms to
the intended use and
defined user needs,
demonstrating the safety

Verification showed
that the system
requirements – derived
from the intended use
and indications for use –
were implemented
correctly, demonstrating
the effectiveness of the
device.
A validation plan for the
final validation of the
release build was
executed on the final
build.
A test report comparing
the numerical results of
the device compared
with the predicate
devices was generated.


and effectiveness of the
subject device.

No, 3mensio is a
traditional software
package, to be installed
on a specific computer

Different, while the
subject device is cloud-
based, the predicate
device is a traditional
software package to be
installed on a specific
computer. FEops
HEARTguideTM
ALPACA is subject to
cybersecurity measures
(see Section 16).


Semi-automatic output
Fully automatic output

Mean of differences (%)
1.4 ± 4.6
4.1 ± 7.2

Confidence interval (CI) on the mean (%)

following results for the semi-automatic and fully automatic outputs respectively:


ostium and the main part of the left atrial appendage.


. In addition, the SW architecture was changed

to separate the image communication platform from the BriefCase SW. The new device consists of

only the algorithm analysis module which can be integrated with image communication platforms that

meet the BriefCase input and output requirements.

algorithm performance, due to training the subject device on a larger data set. Additional operating


Predicate Device
Aidoc Briefcase for RibFx triage
(K202992)

Subject Device
Aidoc Briefcase for RibFx triage

BriefCase is a radiological computer
aided triage and notification software
indicated for use in the analysis of chest
CTs (with or without contrast). The
device is intended to assist hospital
networks and appropriately trained
medical specialists in workflow triage
by flagging and communication of
suspect cases of three or more acute
Rib fracture (RibFx) pathologies.
BriefCase uses an artificial intelligence
algorithm to analyze images and flag
suspect cases on a standalone desktop
application in parallel to the ongoing
standard of care image interpretation.
The user is presented with notifications
for suspect cases. Notifications include
compressed preview images that are
meant for informational purposes only
and not intended for diagnostic use
beyond notification. The device does
not alter the original medical image and
is not intended to be used as a
diagnostic device.
The results of BriefCase are intended to
be used in conjunction with other
patient information and based on their
professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of
care.

BriefCase is a radiological computer
aided triage and notification software
indicated for use in the analysis of chest
CTs (with or without contrast) images in
adults or transitional adolescents aged
18 and older. The device is intended to
assist hospital networks and
appropriately trained medical
specialists in workflow triage by
flagging and communicating suspect
cases of three or more acute Rib
fracture (RibFx) pathologies.
BriefCase uses an artificial intelligence
algorithm to analyze images and
highlight cases with detected findings in
parallel to the ongoing standard of care
image interpretation. The user is
presented with notifications for cases
with suspected RibFx findings.
Notifications include compressed
preview images that are meant for
informational purposes only and not
intended for diagnostic use beyond
notification. The device does not alter
the original medical image and is not
intended to be used as a diagnostic
device.
The results of BriefCase are intended to
be used in conjunction with other
patient information and based on their
professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of
care.

Hospital networks and appropriately
trained medical specialists