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

uAI EasyTriage-Rib uses an artificial intelligence
algorithm to analyze images and highlight
studies with suspected multiple (3 or more) acute
rib fracture(s) in a standalone application for
study list prioritization or triage in parallel to
ongoing standard of care. The user is presented
with notifications of cases with suspected
findings. Notifications include compressed
preview images that are meant for informational
purposes only and not intended for diagnostic
use beyond notification. The device does not
alter the original medical image and is not
intended to be used as a diagnostic device.
The results of uAI EasyTriage-Rib, in conjunction
with other clinical information and professional
judgment, are to be used to assist with
triage/prioritization of medical images. Notified
radiologists who read the original medical
images are responsible for the diagnostic
decision.

Identify patients
with pre-specified
clinical condition

Multiple (3 or more) acute rib fractures.

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


Initial assessment; non-diagnostic purposes

DICOM Information about the patient, study and
current image.

Results Returned
in Standalone
Application


Clinical Site
Sensitivity [95% CI]
Specificity [95% CI]

Table 2: Device Performance per Clinical Site


Age Range (Years)
Sensitivity [95% CI]
Specificity [95% CI]


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


Maximum Aneurysm Diameter
Sensitivity [95% CI]

Table 5: Device Performance by Aneurysm Diameter


Saccular Aneurysm Location
Sensitivity [95% CI]

AComm (including Acomm/ACA junction)
1.0 [0.63, 1.0]

Bifurcation of the M2 segments of the MCA

PComm (including PComm/PCA junction)
0.91 [0.59, 1.0]

ICA or MCA-M1 segment (including ICA/ACA
junction)

Table 6: Device Performance by Saccular Aneurysm Location


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

Table 7: Device Performance by Slice Thickness


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

Table 8: Device Performance by Scanner Manufacturer


Table 9: Device Performance by CT Scanner (Manufacturer/Model)


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

Table 10: Device Performance by Scanner Row Detectors


Regulation Number
Regulation Name
Product Code

Ultrasonic Pulsed Doppler Imaging System

21 CFR § 892.1560
Ultrasound Pulsed Echo Imaging System
IYO

21 CFR § 892.1570
Diagnostic Ultrasonic Transducer
ITX

Regulation Number, Name and Product Codes:


Device Trade Name:
Clarius Ultrasound Scanner

Submitter Name:
Clarius Mobile Health Corp.


C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, PA HD3,
L20 HD3

Clarius Ultrasound App (Clarius App) for iOS;
Clarius Ultrasound App (Clarius App) for Android

The Clarius Ultrasound Scanner comprises the following:


Criteria
SUBJECT DEVICE
PREDICATE DEVICE

Clarius Ultrasound Scanner
Clarius Ultrasound Scanner

510(k) Holder/
Clarius Mobile Health Corp.
Clarius Mobile Health Corp.

Product Codes
IYN1, IYO2, ITX3
IYN1, IYO2, ITX3

Comparison of the Subject Device and Predicate Device for Demonstration of Substantial Equivalence


Ultrasonic Pulsed Doppler Imaging System1;
Ultrasonic Pulsed Echo Imaging System2;
Diagnostic Ultrasonic Transducer3

C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3,
PA HD3, L20 HD3

C3 HD, C7 HD, EC7 HD, L7 HD, L15 HD, PA HD,
L20 HD

Convex Array
Linear Array
Phased Array
Intracavity

Diagnostic ultrasound imaging and fluid flow
analysis of the human body

The Clarius Ultrasound Scanner is a software-
based ultrasound imaging system and
accessories, intended for diagnostic imaging.
It is indicated for diagnostic ultrasound
imaging and fluid flow analysis in the
following applications: ophthalmic, fetal,
abdominal, intra-operative (non-
neurological), pediatric, small organ, cephalic
(adult), trans-rectal, trans-vaginal, musculo-
skeletal (conventional, superficial), urology,
gynecology, cardiac (adult, pediatric),
peripheral vessel, carotid, and procedural
guidance of needles into the body.
The system is a transportable ultrasound
system intended for use in environments
where healthcare is provided by trained
healthcare professionals.
• Ophthalmic
• Fetal
• Abdominal
• Intraoperative (Ab/Vasc)
• Pediatric
• Small Organ
• Adult cephalic
• Trans-rectal
• Trans-vaginal
• Musculoskeletal (conventional)
• Musculoskeletal (superficial)
• Urology
• Gynecology
• Cardiac adult


• Cardiac pediatric
• Peripheral vessel
• Carotid
• Needle guidance

Piezoelectric material in the system’s
transducer transmits high frequency, non-
ionizing sound waves to the designated
region of the body and converts the
subsequent echoes detected to electronic
signals in order to construct an image of the
internal structures of an anatomical field. The
image is sent wirelessly from the transducer
to an external iOS or Android viewing device
on which the image can be displayed.

Internal integrated built-in (non-removable)
lithium-ion battery

Display
iOS or Android mobile device
iOS or Android mobile device

Communicates wirelessly via Wi-Fi and
Bluetooth

Portability
Portable ultrasound system
Portable ultrasound system

Transducers/scanners
Software (Clarius App)
Accessories (Charger and Fan)

B-mode
M-mode
Color Doppler
Power Doppler
Pulse-Wave Doppler (PWD)
Combined (B+M; B+CD; B+PD; B+PWD)

The Clarius Ultrasound Scanner complies with
the following safety standards:
60601-1
60601-1-2
60601-1-6
60601-1-12
60601-2-37


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

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

Medical electrical equipment - Part 1-6: General Requirements for Basic Safety
and Essential Performance - Collateral Standard: Usability

Medical electrical equipment - Part 1-12: General Requirements for Basic
Safety and Essential Performance - Collateral Standard: Requirements for
Medical Electrical Equipment and Medical Electrical Systems Intended for Use
in the Emergency Medical Services Environment

Medical electrical equipment – Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment

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

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

NEMA Standards Publication UD 3-2004 (R2009) Standard for Real-Time
Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic
Ultrasound Equipment

Medical device software – Software life cycle processes

Medical devices – Application of usability engineering to medical devices

Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied

Medical Devices – Application of Risk Management to Medical Devices

Degrees of protection provided by enclosures (IP Code)

Secondary cells and batteries containing alkaline or other non-acid electrolytes
–Safety requirements for portable sealed secondary cells, and for batteries
made from them, for use in portable applications

IEC 61157: Standard means for the reporting of the acoustic output of medical
diagnostic ultrasonic equipment

demonstrate compliance to the following standards:


Primary:
Aquilion ONE (TSX-
306A/3) V10.4 with
Spectral Imaging
System

JAK:
System, X-ray,
Tomography,
Computed


Vitrea Software
Package,
VSTP-001A
(Primary Predicate)

Medical Image
Management
and Processing
System


Aquilion ONE (TSX-
306A/3) V10.4 with
Spectral Imaging
System
(Reference Predicate)


Vitrea Software Package,
VSTP-001A (8.10)

Vitrea Software Package,
VSTP-001A (V8.8)

Acquired by spectral scan
(TSX-306A/3, V10.11 or earlier
and V10.12 and later)

Acquired by spectral scan
(TSX-306A/3, V10.3 or earlier
and V10.4 and later)

Spectral Analysis
• Basis material images and
monochromatic image
o Dual Energy scan (AiCE
Brain reconstruction*
o Segmentation Data derived
from*
 Vitrea CT Myocardial
Perfusion
 Vitrea Coronary Artery
Analysis

Spectral Analysis
• Analysis result display
• Secondary capture (RGB
image)
• Batch MPR and DICOM
volume save

Spectral Analysis
• Generation of
monochromatic images
(ranging from 35keV –
200keV)
o Smoothing filter
• Generation of Iodine map
• VNC image
• Generation of Electron
Density Image
• Generation of Effective Z
Image
• Generation of Basis material
image (bone/water)


Spectral Analysis
• Monochromatic image
o Basis material dual
energy analysis
• Iodine map
o Three material
decomposition
• Electron density
o Basis material dual
energy analysis
• Effective Z
o Basis material dual
energy analysis
• Basis material image
(bone/water)
Basis material dual energy
analysis

• MPR, Fusion image, MIP
image, MinIP image,
Displaying three MPR planes,
• New:
o 3D*
o Chamber View*
o Polar map*
o Curved Planar
Reconstruction (CPR)*
o Stretched Planar
Reconstruction (SPR)*
o Crosscut*
o Fusion to CPR/SPR* and
Crosscut*


Feature
Predicate Device
Reference Device
Subject Device
Discussion /

TOMTEC-ARENA
Philips EPIQ and Affiniti Ultrasou
nd
TOMTEC-ARENA
Comment

Regulation Number
21 CFR 892.2050;
21 CRF 892.1550
21 CFR 892.2050;
Identical to predica

and Regulation Name
System, Image processing,
Ultrasonic pulsed doppler imaging s
ystem.
System, Image processing,
device.

Picture Archiving and
Picture Archiving and

Communications System
Communications System

Classification Product
LLZ
IYN
QIH
Identical to predica

Subsequent Product
QIH
ITX, IYO, OBJ, QIH
LLZ
Identical to predica

Classification Panel
Radiology
Radiology
Radiology
Identical to predica

Device Name
TOMTEC-ARENA
EPIQ Series Diagnostic Ultrasound
System,
TOMTEC-ARENA
Identical to predica

Affiniti Series Diagnostic Ultrasound
System
device.

(Ultrasound System Software
device changed du

TOMTEC Imaging Systems GmbH
Pa
ge 4 of 10


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

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

Intended Use/
Indications for use of
predicate and subject
device are identical
(unchanged).Intended
Use/ Indications for
use of reference
device and subject
device are similar and
considered equivalent
(specifically if
compared for the
clinical use case/
workflow of the subject
feature).

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

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

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

Hospitals, clinics, and
physician´s offices.

Clinics, hospitals, and clinical point-of care
for diagnosis of patients.

Inside and outside of
Hospitals, Clinics, and
Physician´s offices.

Subject of submission;
The intended use
environment was
revised and extended.
Environmental
conditions have been
considered.


Reference Device
Philips EPIQ and Affiniti Ultrasound
Systems
with Auto Measure

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

Auto Measure is an optional software feature
on the EPIQ/Affinity Series Diagnostic
Ultrasound System that provides the end
user with semi automated adult
echocardiography 2D and Doppler
measurements through an AI-algorithm,
training via machine-learning techniques. It
is intended to be used with an Adult
Cardiology Transthoracic transducer and
acquisitions that include an ECG. These
measurements are routinely collected during
a transthoracic ECG, per The American
Society of Echo cardiography (ASE)
recommendations

Identical to predicate
device.
Similar and considered
equivalent to the
reference device
(specifically if
compared for the
clinical use
case/workflow of the
subject feature).

Version of module
IMAGE-COM changed
due to new features.


Semi-automated adult echocardiography 2D
and Doppler measurements are generated
using an artificial intelligence (AI) detection
algorithm without user interaction. After
measurement is generated, the user can edit
(manually adjust the caliper positions),
accept, or reject the measurements.The
automation of measurements is constrained
to the specific imaging mode (2D, Doppler)
as recommended by ASE guidelines.

Subject of submission;
Proposed feature
includes optional semi-
automation of existing
measurements
available to the end
user during routine
ultrasound exam
similar to reference
device. Semi-
automated
measurements
quantify image data
through an AI-based
algorithm that was
trained with a
machine-learning
model.Workflow
improvements for user
convenience.No
impact to the safety or
effectiveness of the
device.

User selects an adult echocardiography 2D
or Doppler measurement to perform then the
caliper positions are initialized based on the
output of the AI detection algorithm.
The user can edit, accept, or reject the
measurements.

Similar to predicate
and reference device.
The set of available
measurements are
unchanged to the
predicate device.
Workflow
improvements for user
convenience.
No impact to the safety
or effectiveness of the
device.


Predicate:
AIMI-Triage CXR PTX
(RADLogics, Inc.)
K193300

Subject Device:
ClearRead Xray
Pneumothorax
(Riverain Technologies, Inc.)
K213566

The AIMI-Triage CXR PTX
provides a chest X-ray
prioritization service for use
by radiologists to identify
features suggestive of
moderate to large sized
pneumothorax.

ClearRead Xray
Pneumothorax provides a
chest X-ray prioritization
service for use by radiologists
to identify features suggestive
of pneumothoraces in a
PA/AP chest x-ray scan.

Clinical Condition
Pneumothorax
Pneumothorax

Artificial intelligence
algorithm with database of
images


Data distribution with respect to device characteristics are summarized below:


Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC, Best, The Netherlands
Establishment Registration Number: 3003768277

Primary Contact
Person:
Secondary Contact
Person

Jan van de Kerkhof
Sr. Manager Regulatory Affairs
Telephone: +31 613300542
E-mail: jan.van.de.kerkhof@philips.com
Susan Quick
Regulatory Affairs Specialist
Telephone: (440) 8694612
E-mail: susan.quick@philips.com

Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR
Systems

Magnetic Resonance Diagnostic Device
(MRDD)

Achieva, Intera, Ingenia, Ingneia CX, Ingenia
Elition, And Ingenia Ambition MR Systems
R5.7

Manufacturer:
Philips Medical Systems Nederland B.V.


There are no changes to the indications for use statement, provided
below, of the proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition and
Ingenia Ambition MR Systems.
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 Achieva, Ingenia, Ingenia CX, Ingenia Elition and
Ingenia Ambition 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 Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia
Ambition MR Systems are identical to those used in the legally
marketed predicate device Achieva, Intera, Ingenia, Ingenia CX,
Ingenia Elition and Ingenia Ambition MR systems R5.7 (K193215,
04/10/2020).
The software R11 used on the proposed Achieva, Ingenia, Ingenia
CX, Ingenia Elition and Ingenia Ambition MR Systems has been
modified to include the SmartSpeed AI feature combining the
previously cleared and legally marketed feature Compressed-SENSE
(K193215, 04/10/2020) with machine learning to allow for higher
accelerations with equal or better image quality.

Summary of Non-
Clinical
Performance Data:

The proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition and
Ingenia Ambition MR Systems are 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)


Ambition 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 Achieva, Ingenia, Ingenia CX, Ingenia
Elition and Ingenia Ambition MR Systems are substantially
equivalent to the legally marketed predicate devices Achieva, Intera,
Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR
systems R5.7 (K193215, 04/10/2020), in terms of safety and
effectiveness.

The proposed Ingenia Achieva, Ingenia, Ingenia CX, Ingenia Elition
and Ingenia Ambition 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 Achieva, Ingenia, Ingenia CX, Ingenia Elition and
Ingenia Ambition MR Systems and the legally marketed predicate
device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and
Ingenia Ambition MR systems R5.7 (K193215, 04/10/2020), 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 Achieva, Ingenia, Ingenia CX, Ingenia Elition and
Ingenia Ambition MR Systems are substantially equivalent to the
legally marketed predicate device Achieva, Intera, Ingenia, Ingenia
CX, Ingenia Elition and Ingenia Ambition MR systems R5.7
(K193215, 04/10/2020), 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
requirements specified in the international and FDA-recognized
consensus standards and device-specific guidance.
The results of these tests demonstrate that the proposed Achieva,
Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR
Systems meet the acceptance criteria and are adequate for the intended
use.


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

Qiang Ding
Regulatory Affairs Program Manager
Phone: +86 13311385163
Email: Ding.Qiang@ge.com

Glen Sabin
Regulatory Affairs Director
Phone: 262-894-4968
Email: Glen.Sabin@ge.com

The SIGNATM Artist Evo system is a whole body magnetic resonance
scanner designed to support high resolution, high signal-to-noise
ratio, and short scan times. The system features a superconducting
magnet. The data acquisition system accommodates up to 128
independent receive channels in various increments and multiple
independent coil elements per channel during a single acquisition
series. The system uses a combination of time varying magnetic 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

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


oblique planes, using various pulse sequences and reconstruction
algorithms.

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

Many of the technological characteristics of the proposed SIGNATM
Artist Evo system are unchanged from the predicate device. The
SIGNATM Artist Evo system reuses GE Healthcare 1.5T LCC
magnets in the installed base, and introduces the new IRMW
gradient coil. There are no changes to the RF transmit and receive
subsystems compared to the predicate K202238. Key performance
specifications (such as magnet stability and spatial homogeneity,
maximum gradient strength, etc.) for the system are also
unchanged.
The SIGNATM Artist Evo system also uses the same version
software as the predicate device with some minor changes to
accommodate the hardware differences. There are no changes to
the pulse sequences, imaging protocols and image processing.

Determination
of
Substantial
Equivalence:

Summary of Non-Clinical Tests:
The SIGNATM Artist Evo and the predicate device were subject to
similar risk management activities and performance testing to
demonstrate substantial equivalence of safety and performance.
Testing included compliance to the following voluntary standards:
 AAMI/ANSI ES60601-1
 IEC 60601-1-2
 IEC 60601-2-33
 AAMI/ANSI 62304
 ISO 10993-1


In addition, the SIGNATM Artist Evo was tested in accordance with
applicable NEMA MS standards for MRI, and complies with the
NEMA PS3 standard for DICOM, as does the predicate device.
Both the SIGNATM Artist Evo and the predicate device are
compliant with ISO 10993.
The following quality assurance measures were applied to the
development of the subject device, as they were for the predicate
device:
 Risk Analysis
 Requirements Reviews
 Design Reviews
 Testing on unit level (Module verification)
 Integration testing (System verification)
 Performance testing (Verification)
 Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, the SIGNATM Artist Evo,
did not require clinical studies to support substantial equivalence.
Sample clinical images have been included in this submission. The
sample clinical images demonstrate acceptable diagnostic image
performance of the SIGNATM Artist Evo in accordance with the FDA
Guidance “Submission of Premarket Notifications for Magnetic
Resonance Diagnostic Devices” issued on November 18, 2016.
The image quality of the SIGNATM Artist Evo is substantially
equivalent to that of the predicate device.
Substantial Equivalence Conclusion:
The indications for use of the proposed device are comparable to
the claimed predicate device. The SIGNATM Artist Evo employs
equivalent technology to the claimed predicate device. Additionally,
the results from the above non-clinical tests demonstrate that the
device performs as intended. Therefore, the SIGNATM Artist Evo is
substantially equivalent to the predicate device to which it has been
compared.

Conclusion
Drawn from
Performance
Testing:

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


Date Summary Prepared:
November 1(cid:21), 2021


Radiological Image Processing Software for
Radiation Therapy

Medical image management and processing
system(21 CFR 892.2050)


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

Sandra Westphal
Regulatory Affairs Leader
GE Healthcare
Phone: 262-720-8872
E-mail: Sandra.westphal@ge.com

Glen Sabin
Director, Regulatory Affairs
GE Healthcare
Phone: 262-521-6848
E-mail: glen.sabin@ge.com

Magnetic Resonance Diagnostic Device per 21 CFR
892.1000

SIGNA™ Hero is a whole body magnetic resonance scanner
designed to support high resolution, high signal to-noise ratio, and
short scan times. The systems use 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 oblique planes, using various
pulse sequences, imaging techniques and reconstruction
algorithms. The system features a 3.0T superconducting magnet
with 70cm bore size. The system is designed to conform to NEMA
DICOM standards (Digital Imaging and Communications in
Medicine).

The SIGNA™ Hero 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™ Hero
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™ Hero employs the same fundamental scientific
technology as its predicate device.
SIGNA™ Hero offers two magnet configurations, building on the
3.0T 3TLC magnet, and introducing the newly designed 3.0T
ARES (Platform) magnet. SIGNA™ Hero builds on the existing
Gradient Driver design, RF transmit architecture design, RF
receive chain design and software platform. SIGNA™ Hero offers
a detachable eXpress patient table, similar to detachable tables
available on other GEHC 3T MR systems.


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

Comparison of
Technological
Characteristics

Overall, the SIGNA™ Hero employs the same fundamental
scientific technology as the predicate device.
System Design: There are one notable technological difference
between the SIGNA™ Hero and the predicate device: the 3.0T
ARES (Platform) magnet.
Operating Principles: The SIGNA™ Hero functions using the
same operating principles as the predicate device.
Materials: The SIGNA™ Hero and the predicate device both use
flame retardant materials.
Safety and Performance Testing: Both the SIGNA™ Hero and
the predicate device comply with the same safety and performance
testing (see Determination of Substantial Equivalence, below).
These technological differences do not raise any different
questions regarding safety and effectiveness. Both devices must
address questions of whether they provide an adequate level of
image quality appropriate for diagnostic use. The performance
data described in this submission include results of both bench
testing and clinical testing that show the image quality
performance of SIGNA™ Hero compared to the predicate device.

Determination of
Substantial
Equivalence:

Summary of Non-Clinical Tests:
The SIGNA™ Hero and the predicate device were subject to
similar risk management testing to demonstrate substantial
equivalence of safety and performance.
Testing to the following voluntary standards included:
• ANSI/AAMI ES60601-1
• IEC 60601-1-2


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

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


Predicate Device
FDA Clearance Number
Product
Manufacturer


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Sensitivity encoding for fast MRI. Magn Reson Med. 1999;42:952-962.

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[10] Demir et al., Optimization of Magnetization Transfer Contrast for EPI
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[11] Clifford et al., Clinical evaluation of an AI-accelerated two-minute
multi-shot EPI protocol for comprehensive high-quality brain imaging,
Proceedings of the ISMRM 2021, abstract 300

[12] Filho et al., Clinical Evaluation of An AI-Accelerated Two-Minute
Multi-Shot EPI Protocol For Comprehensive High-Quality Brain MRI In An
Emergency And Inpatient Setting, Proceedings of the RSNA 2021,
accepted, abstract 16890

[13] Pistocchi et al., AI-enhanced multi-shot multi-contrast EPI protocol:
Preliminary clinical experience, Proceedings of the ECR 2022, submitted

[14] Gassenmaier S et al., Deep learning–accelerated T2-weighted
imaging of the prostate: Reduction of acquisition time and improvement
of image quality, European Journal of Radiology, 137 (2021)

[15] Herrmann J et al., Diagnostic Confidence and Feasibility of a Deep
Learning Accelerated HASTE Sequence of the Abdomen in a Single
Breath-Hold, Investigative Radiology, Volume 56, Number 5, May 2021

[16] Shanbhogue K et al. Accelerated single-shot T2-weighted fat-
suppressed (FS) MRI of the liver with deep learning-based image
reconstruction: qualitative and quantitative comparison of image quality
with conventional T2-weighted FS sequence. Eur Radiol. 2021 May 7.

[17] Herrmann J et al., Development and Evaluation of Deep Learning-
Accelerated Single-Breath-Hold Abdominal HASTE at 3 T Using Variable
Refocusing Flip Angles. Invest Radiol. 2021 Apr 22.

[18] Gassenmaier S et al., Accelerated T2-Weighted TSE Imaging of the
Prostate Using Deep Learning Image Reconstruction: A Prospective
Comparison with Standard T2-Weighted TSE Imaging, Cancers, 13,
3593 (2021)


[19] Herrmann J et al., Feasibility and implementation of a Deep Learning
MR reconstruction for TSE sequences in musculoskeletal imaging,
Diagnostics, 11, 1484 (2021)

Publications under review:
[20] Judith Herrmann et al., Feasibility and diagnostic confidence of deep
learning reconstructed TSE imaging of the knee at 1.5 and 3 T. A
prospective study.

[21] Alsop, D. C. (1997). Phase insensitive preparation of single
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BLADE-DWI (TGSE-BLADE-DWI) for orbital tumors compared
with readout-segmented echo-planar DWI. Proc. Intl. Soc. Mag.
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3 T: preliminary experience in children. Academic radiology, 1597-1604.

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Diffusion-Weighted FSE UsingPROPELLER MRI. Magnetic Resonance
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Performance of TGSE BLADE DWI compared with RESOLVE DWI in the
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(2020). TGSE diffusion-weighted pulse sequence in the evaluation of
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[29] Zhou, K., Liu, W., & Cheng, S. (2018). Non-CPMG PROPELLER
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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)

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

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
[Including Amendment 1 (2016)]

Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices

Standards Publication
Characterization of Phased
Array Coils for Diagnostic
Magnetic Resonance Images

Digital Imaging and
Communications in Medicine
(DICOM) Set 03/16/2012
Radiology

Characterization of
Radiofrequency (RF) Coil
Heating in Magnetic Resonance
Imaging Systems

FDA recognized and international IEC, ISO and NEMA standards:


Subject Device:
AI-Rad Companion
Brain MR VA40

AI-Rad Companion
Brain MR is a post-
processing image
analysis software that
assists clinicians in
viewing, analyzing, and
evaluating MR brain
images.

icobrain is intended
for automatic
labeling,
visualization and
volumetric
quantification of
segmentable brain
structures

raise different questions of the safety and effectiveness.


Calculation of label
maps (display of brain
segmentation) and
partially combined label
maps (fused with the
processed MPRAGE
data).

Normalized and
unnormalized
volume and volume
changes of different
brain structures.

Calculation of deviation
map (representation of
brain status in relation to
reference data) and
partially combined
deviation maps (fused
with the processed
MPRAGE data) User
customizable color labels
for the overlay map.

Brain White
Matter
Hyperintensities
Segmentation

Pre-processing
functionality for
automatic segmentation
and volumetry of
MPRAGE and FLAIR
data.

Image processing for
automatic
segmentation and
volumetry of FLAIR
data.

Brain White
Matter
Hyperintensities
Quantification

Calculation of white
matter hyperintensities
count and volume as per
4 brain regions.

Unnormalized
volume and volume
changes of FLAIR
white matter
hyperintensities as
per 4 brain regions

Calculation of white
matter hyperintensities
map fused with the
processed FLAIR data
User customizable color
labels for the overlay
map.

Calculation of white
matter
hyperintensities map
overlaid with the
FLAIR data

Creation of an image
series for a morphometry


morphometry report.
Automatic transfer of
generated maps and
morphometry report to
a PACS system.

Confirmation UI with
basic visualization
functionality

Cloud solution and Edge
components deployed on
customer premise.

Cloud only solution
with no components
deployed on customer
premise.

DICOM structured
report representation of a
natural language report


PCC 95% Confidence Interval includes 0.91

ICC 95% Confidence Interval includes 0.95

Voxel-wise Segmentation Accuracy
Mean Dice score >= 0.58

WMH Lesion-wise Segmentation Accuracy
Mean F1-score >= 0.57

Lower Bound of the 95% Bootstrap CI Dice >=
0.63


Summary Performance data, Standard Deviations & CIs:


MS – 36
Cognitive Impairment – 17
Other neurological disease – 5
Cognitive Normal – 5
Unknown – 1

New York (US): 25
ADNI (US): 12
Lausanne (CH): 8
CLEMENS (CH): 10
Montpellier (FR): 9


AI-Rad Companion (Pulmonary)
AI-Rad Companion (Pulmonary)

Creation of a lung segmentation mask
by combining the segmentation masks
of 5 lung lobes.

Computation of segmentation masks
of the five lung lobes (right upper
(RUL), right middle (RML), right
lower (RLL), left upper (LUL) and
left lower (LLL) lobe) for a given CT
data set of the chest.

The parenchyma evaluation uses the
lobe mask, counts all voxels per lobe,
counts image voxels below -950 HU,
and calculates the percentages of
these voxels relative to the total
number of voxels. Additionally, it
sums the individual lobe results and
calculates the percentage for the
complete lung.

The percentages are likewise
dedicated to the 4 ranges. Name of
ranges and their ranges are
configurable by the user.

AI‐based identification of areas with
elevated Hounsfield values.
Threshold‐based identification of
highest elevated Hounsfield values


inside these elevated regions, by a
predefined threshold of ‐200 HU

Visualization
of
segmentation
and
parenchyma
results

Color overlay of MPR and VRT with
evaluation results

Segmentation of lung lesions
including the following data:
• Relative change of maximum
2D diameter [%]
• relative change of maximum
orthogonal 2D diameter [%]
• relative change of mean 2D
diameter [%],
• relative change of maximum
3D diameter [%]
• Relative change of volume
(volume doubling time [d],
negative growth [%])

Segmentation of lung lesions with the
following data (not shown to the
user):
• Relative change of maximum
2D diameter [%]
• relative change of maximum
orthogonal 2D diameter [%]
• relative change of mean 2D
diameter [%],
• relative change of maximum
3D diameter [%]
• Relative change of volume
(volume doubling time [d],
negative growth [%])

Visualization
of lesion
segmentation
results

Correlation of segmented lung lesions
with known priors using the data from
the lesion segmentation.


Medical Devices – Application
of usability engineering to
medical devices [including
Corrigendum 1 (2016)]

Medical Devices – application
of risk management to medical
devices

Medical device software –
software life cycle processes
[Including Amendment 1
(2016)]

Digital Imaging and
Communications in Medicine
(DICOM) Set

Information Technology –
Digital Compression and coding
of continuous -tone still images:
Requirements and Guidelines
[including: Technical
Corrigendum 1(2005)]

following voluntary FDA recognized Consensus Standards listed in Table 1 below.


Predicate Device
FDA Clearance
FDA Clearance
Main Product Code


Predicate Device
Aidoc BriefCase for ICH triage
(K203508)

Subject Device
Aidoc Briefcase for BA triage

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

BriefCase is a radiological computer aided
triage and notification software indicated for
use in the analysis of head CT Angio (CTA)
images. The device is intended to assist
hospital networks and appropriately trained
medical specialists in workflow triage by
flagging and communication of suspected
positive cases of Brain Aneurysm (BA)
findings above 5 mm size.
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 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


DICOM Information about the patient, study
and current image

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

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

Artificial intelligence Deep-learning
algorithm with database of images.

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

No. The device operates in parallel with the
standard of care, which remains the default
option for all cases.

- AHS module (image acquisition).
- ACS module (image processing).
- Aidoc Worklist application (worklist
and Image Viewer).


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

Yonghui Han
Regulatory Affairs Leader
GE Healthcare
(86)10 57083350/(+86) 13311387032
Yonghui.Han@ge.com

Elizabeth Mathew
Senior Regulatory Affairs Manager
GE Healthcare
Tel:(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
LLZ
Class II


Predicate Device
Device name:
Manufacturer:
510(k) number:
Regulation Number:
Product Code:
Classification:

SmartScore 4.0
GE Medical Systems SCS
K020929
21 CFR 892.1750 Computed tomography X-Ray System
JAK
Class II

Reference Devices
Device name:
Manufacturer:
510(k) number:
Regulation Number:
Product Code:
Classification:
Device name:
Manufacturer:
510(k) number:
Regulation Number:
Product Code:
Classification:

CardIQ Xpress 2.0
GE Medical Systems SCS
K073138
21 CFR 892.1750 Computed tomography X-Ray System
JAK
Class II
Syngo.CT CaScoring
Siemens Medical Solutions USA, Inc.
K201034
21 CFR 892.1750 Computed tomography X-Ray System
JAK
Class II

510(k) Premarket Notification Submission-CardIQ Suite


Predicate
Device:
SmartScore 4.0
(K020929)

Segmentation
and labeling
calcific regions
in the
coronaries

Substantial Equivalent
Deep Learning Algorithm is incorporated in CardIQ Suite to
automatically segment and label the calcific regions in the
coronary arteries in order to improve workflow efficiency
over the manual approach that exists in the predicate
device.
Automated calcium scoring evaluation already exists in the
reference device Syngo.CT CaScoring (K201034).

Manual
Segmentation
and labeling of
calcific regions

Substantial Equivalent
Coronary 2D Reviews Toolset is available in CardIQ Suite to
assist users for a seamless integrated review of coronary
artery imaging along with automated calcium scoring
feature.
This tool set contains identical features to what already
exists in the reference device CardIQ Xpress 2.0 (K073138)

predicate device and the proposed device:


Absolute difference of
the relative volumes [pp]

Hippocampus total
Hippocampus right
Hippocampus left

comparison. The results are summarized below.


Frontal lobe total
C
0.95 ± 0.01
1.21 ± 1.22

Frontal lobe right
0.94 ± 0.02
0.76 ± 0.58

Frontal lobe left
0.94 ± 0.02
0.60 ± 0.67

Occipital lobe total
Occipital lobe right
Occipital lobe left

Parietal lobe total
C
0.89 ± 0.03
1.21 ± 1.31

Parietal lobe right
0.88 ± 0.04
0.73 ± 0.76

Parietal lobe left
0.88 ± 0.03
0.64 ± 0.67

Temporal lobe total
Temporal lobe right
Temporal lobe left

Cerebellum total
C
0.99 ± 0.00
0.19 ± 0.13

Cerebellum right
0.97 ± 0.01
0.12 ± 0.07


Predicate
Device
QCT Bone
Mineral Density
Analysis
Software
K894854

Estimate bone
mineral density
within the spine.

the ABMD Software is substantially equivalent to the predicate device.


Device provides
the bone mineral
density value.

Equivalent,
software
function is
independent
from
operating
system.

Retrospective
measurements
from CT scans.

CT scan images
can be selected and
inputted to the
software.

Software
automatically
measures and
averages
Hounsfield units in
the trabecular


Inputting CT
scanner-specific
calibration factor is
required. Software
outputs calibrated
BMD score.

Simultaneous
scanning of
calibration
phantom is
required.
Software outputs
calibrated BMD
score.

Asynchronous
scanning of
calibration
phantom is
required.
Software outputs
calibrated BMD
score.

Equivalent.
Software
provides
measurements
corrected for
calibration
data.


993 quantitative CT (QCT) readings of a
cohort of asymptomatic cases who
underwent CT scans.

172 asymptomatic cases who underwent
whole-body DXA scans as well as CT
scans.

QCT BMD, T-score, and Z-score values
derived from manual measurement by
trained operators.

DXA scans derived T-score, and Z-score
values plus QCT BMD, T-score, and Z-
score values derived from manual
measurement by trained operators.

Pearson Correlation, Deming
Regressions, and Bland Altman
Agreement

Strong correlations and agreements were
found between manual QCT and ABMD
Software. Modest but significant
correlations and agreement were found
between DXA, and ABMD Software.


Submitted by
Resonance Health Analysis Servi

US Contact (US Agent)
Michael van der Woude


LiverSmart (Subject Device)
FerriSmart (Predicate)
HepaFat-AI (Predicate)

Liver Iron Concentration Imaging
Companion Diagnostic for Deferasirox
System, Nuclear Magnetic Resonance
Imaging, System, Image Processing
Radiological

Standalone software package that
automatically analyses magnetic resonance
imaging (MRI) datasets to generate an
estimate of the patient’s volumetric liver fat
fraction (VLFF), proton density fat fraction
(PDFF), steatosis grade, and liver iron
concentration (LIC). LiverSmart evaluates
images acquired using the FerriSmart and
HepaFat-AI protocols and analyses the
acquired data to produce a ‘multi-
parametric’ reporting both fat metrics and
LIC.

Standalone software package that
automatically analyses multi-slice, spin-
echo MRI data sets encompassing the
abdomen to provide objective and
reproducible determination of liver
parameters to support clinicians in the
assessment of liver iron status. The
software tool determines the signal decay
rate (R2) that is used to characterize iron
loading in the liver, which is then
transformed by a defined calibration curve
to provide a quantitative measure of liver
iron concentrations in vivo.

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

The table below summarizes the main similarities and differences between LiverSmart and the predicates.


Convolutional neural networks for the
image analysis.
Algorithmic for the image’s quality checks,
R2 conversion into LIC, and Alpha
conversion into VLFF.

Convolutional neural networks for the
image analysis.
Algorithmic for the image’s quality checks
and R2 conversion into LIC.

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

1. Supporting clinical diagnoses about the
status of LIC and the status of liver fat
content.
2. Supporting the subsequent clinical
decision-making processes.
3. Supporting the use in clinical research
trials, directed at studying changes in
LIC and liver fat as a result of
interventions.

1. Supporting clinical diagnoses about the
status of LIC.
2. Supporting the subsequent clinical
decision-making processes.
3. Supporting the use in clinical research
trials, directed at studying changes in
LIC as a result of interventions.

1. Supporting clinical diagnoses about the
status of liver fat content.
2. Supporting the subsequent clinical
decision-making processes.
3. Supporting the use in clinical research
trials, directed at studying changes in liver
fat as a result of interventions.

1. For the measurement of R2 and iron
concentration in the liver from MRI
scans.
2. For quantitative measurement of the
triglyceride fat fraction in magnetic
resonance images of the liver, also
known as volumetric liver fat fraction
(VLFF).

1. Measurement of R2 and iron
concentration in the liver from MRI
scans

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


LiverSmart is indicated to:
For Liver Iron Concentration
1. measure liver iron concentration in
individuals with confirmed or suspected
systemic iron overload;
2. monitor liver iron burden in transfusion
dependent thalassemia patients and
patients with sickle cell disease
receiving blood transfusions;
3. aid in the identification and monitoring
of non-transfusion-dependent
thalassemia patients receiving therapy
with Deferasirox.
For Liver Fat Assessment
1. assess the volumetric liver fat fraction,
proton density fat fraction and steatosis
grade in individuals with confirmed or
suspected fatty liver disease.
When interpreted by a trained physician, the
results can be used to:
2. monitor liver fat content in patients
undergoing weight loss management;
3. aid in the assessment and screening of
living donors for liver transplant.

FerriSmart is Indicated to:
1. measure liver iron concentration in
individuals with confirmed or
suspected systemic iron overload;
2. monitor liver iron burden in
transfusion dependent thalassemia
patients and patients with sickle cell
disease receiving blood transfusions;
3. aid in the identification and monitoring
of non-transfusion-dependent
thalassemia patients receiving therapy
with Deferasirox.

HepaFat-AI is indicated to:
1. assess the volumetric liver fat fraction,
proton density fat fraction and steatosis
grade in individuals with confirmed or
suspected fatty liver disease.
When interpreted by a trained physician, the
results can be used to:
2. monitor liver fat content in patients
undergoing weight loss management;
3. aid in the assessment and screening of
living donors for liver transplant.

User Radiologist Radiologist Radiologist

Hosting platform
Cloud-based or on-site hosting
Cloud-based or on-site hosting
Cloud-based or onsite platform


LiverSmart (Subject Device)
FerriSmart (Predicate)
HepaFat-AI (Predicate)

Single Spin Echo (SSE)
Gradient Recalled Echo (GRE)

LiverSmart:
(i) Data Preparation Module; and
(ii) Report Generation Module
FerriSmart:
(i) Magnetic Resonance Imaging
Protocol;
(ii) FerriSmart Analysis Software; and
(iii) Liver Iron Concentration
Measurement.
HepaFat-AI:
(i) Magnetic Resonance Imaging
Protocol;
(ii) HepaFat-AI Analysis Software;
(iii) Volumetric Liver Fat Fraction
Measurement;
(iv) Proton Density Fat Fraction
Measurement; and

(i) Magnetic Resonance Imaging
Protocol
(ii) FerriSmart Analysis Software
(iii) Liver Iron Concentration
Measurement

(i) Magnetic Resonance Imaging Protocol
(ii) HepaFat-AI Analysis Software
(iii) Volumetric Liver Fat Fraction
Measurement
(iv) Proton Density Fat Fraction
Measurement
(v) Steatosis Grade Measurement


Page 1
(i) Report No., patient ID, patient name and
date of birth for full identification of the
patient.
(ii) Scan date, and analysis date.
(iii) Referrer and MRI centre.
(iv) Results displayed: LIC (mg/g dry
tissue), LIC (mmol/kg dry tissue),
associated with confidence intervals and
normal range.
(v) Results displayed: VLFF (%), PDFF (%)
and Steatosis grade, associated with
confidence intervals and normal range.
Page 2
As per FerriSmart report
Page 3
As per HepaFat-AI report

(i) Patient ID, patient name and date of
birth for full identification of the
patient.
(ii) Scan date, and analysis date.
(iii) Referrer and MRI centre.
(iv) Results displayed: LIC (mg/g dry
tissue), LIC (mmol/kg dry tissue),
associated with confidence intervals
and normal range.
(v) Pictures of the 5 TEs of the analysed
slice.
(vi) LIC thresholds table

(i) Patient ID, patient name and date of
birth for full identification of the patient.
(ii) Scan date, and analysis date.
(iii) Referrer and MRI centre.
(iv) Results displayed: VLFF (%), PDFF (%)
and Steatosis grade, associated with
confidence intervals and normal range.
(v) NASH-CRN Steatosis Grading Guide
(vi) Pictures of the 3 TEs of the analysed
slice.
(vii) Liver colour map (for illustration
purpose only, not for diagnostic)


Trade or proprietary or model name
Preview Shoulder

The predicate device to which substantial equivalence is claimed:


Applicant
VideaHealth, Inc.
Carestream Dental LLC

Device Name
Videa Caries Assist
Logicon Caries Detector


Videa Caries Assist is a
computer-assisted detection
(CADe) device that analyzes
intraoral radiographs to
identify and localize carious
lesions. Videa Caries Assist is
indicated for use by board
licensed dentists for the
concurrent review of bitewing
(BW) radiographs acquired
from adult patients aged 22
years or older.

Logicon Caries Detector is a
software device that is an aid in the
diagnosis of caries that have
penetrated into the dentin on un-
restored proximal surfaces of
secondary dentition through the
statistical analysis of digital intra-
oral radiographic imagery. The
device provides additional
information for the clinician to use in
his/her diagnosis of a tooth surface
suspected of being carious. It is
designed to work in conjunction with
an existing CareStream Dental RVG
Digital X-Ray Radiographic System
with Dental Imaging Software (DIS)
for Windows XP or higher.

Active and Secondary Caries
at all penetration depths

Proximal, Buccal/Lingual,
Occlusal, Root, Cervical

Message indicating if a carious
lesion was detected.
An outline of the potential lesion site
is shown

Patient Population
Adults ≥ 22 years of age
Adults ≥ 22 years of age
Adults ≥ 22 years of age

Intended User
US licensed dentists
Dentists

Development Technology
Supervised Deep Learning
Computer Vision

Image Viewing
Image Viewing
Image Viewer
Image Viewer
CareStream Dental RVG Digital X-


Overall average Se - image-based (%)
70.8
(68.0, 73.7)

Overall average PPV - image-based (%)
59.5
(56.5, 62.5)

Overall average Se (%) - lesion-based (pooled)

Overall average PPV (%) - lesion-based
(pooled)

Table 2: Standalone: AFROC FOM, Image-based Se, PPV. Lesion-based estimates in italics.


Table 3: Overall Image-based AFROC FOM for Aided vs Unaided reads


Predicate Device
Aidoc Briefcase iPE triage (K203508)

Subject Device
Aidoc Briefcase iPE triage (K213886)

BriefCase is a radiological computer
aided triage and notification software
indicated for use in the analysis of
contrast-enhanced chest CTs (but not
dedicated CTPA protocol). The device is
intended to assist hospital networks and
appropriately trained medical specialists
in workflow triage by flagging and
communication of suspected positive
cases of incidental Pulmonary Embolism
(iPE) pathologies. For the iPE pathology,
the software is only intended to be used
on single-energy exams. The device is
intended to work with GE and Siemens
scanners only.
BriefCase uses an artificial intelligence
algorithm to analyze images and flag
suspect cases on a standalone desktop
application in parallel to the ongoing
standard of care image interpretation. The
user is presented with notifications for
suspect cases. Notifications
include compressed preview images that
are meant for informational purposes only
and not intended for diagnostic use
beyond notification. The device does not
alter the original medical image and is not
intended to be used as a diagnostic
device.
The results of BriefCase are intended to
be used in conjunction with other
patient information and based on their
professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of
care.

BriefCase is a radiological computer aided
triage and notification software indicated for
use in the analysis of contrast-enhanced
chest CTs (not dedicated CTPA protocol) in

adults or transitional adolescents age 18

Appropriately trained medical specialists


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

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

Contrast-enhanced chest CTs (not
dedicated CTPA protocol)

DICOM Information about the patient,
study and current image

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

Artificial intelligence algorithm with
database of images

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

No. The device operates in parallel with
the standard of care, which remains the
default option for all cases.

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

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


positive = 2.6%1, Confidence limits computed using the "exact" Clopper-Pearson method


Table 3. PLR/NLR Ratios with Two-Sided 95% Confidence Limits (Efficacy Population)


Subsystem
Revolution Ascend
Revolution Ascend

(Predicate Device, K203169)
(Proposed Device)

Revolution Ascend Gantry
- Bore size: 75cm
- Physical Tilt (± 30°)
Performix 40 Plus X-Ray Tube
- Supports 40 mm beamwidth
- Liquid Metal rotor bearing
JEDI60DC High Voltage Generator
- Peak Power: 72 kW
NGX Collimator (75cm bore)
- 40 mm max z-coverage
Merc40L Detector
- Backlit Diode technology
- Chiclet Module design
- GE low noise ASIC technology
used for signal conversion

Revolution Ascend Gantry
- Bore size: 75cm
- Physical Tilt (± 30°)
Performix 40 Plus X-Ray Tube
- Supports 40 mm beam width
- Liquid Metal rotor bearing
JEDI60DC High Voltage Generator
- Peak Power: 72 kW
NGX Collimator (75cm bore)
- 40 mm max z-coverage
Merc40H Detector
(with alternative material)
- Backlit Diode technology
- Chiclet Module design
- GE low noise ASIC technology
used for signal conversion

NIO Console:
- Host computer, keyboard,
scan control unit, two
monitors.


Deep Learning
Image
Reconstruction
(DLIR)

DLIR cleared with Revolution Ascend
(K212067).

510(k) Premarket Notification Submission for Revolution Ascend


Level 21, 60 Margaret Street
Sydney, NSW 2000
Australia


Annalise Enterprise CXR Triage Pneumothorax

Radiological computer aided triage and notification software
(21CFR892.2080)


Manufacturer Name
Behold.AI Technologies Limited


Predicate Device:
AI-Rad Companion (Musculoskeletal)

Classification Name
Computed tomography x-ray system.

The HealthOST device is substantially equivalent to the following Predicate Device:


Primary Predicate Device:
AI-Rad Companion
(Musculoskeletal) (K193267)

HealthOST is an image processing
software that provides qualitative and
quantitative analysis of the spine from
CT images to support clinicians in the
evaluation and assessment of
musculoskeletal disease of the spine.
The HealthOST software provides the
following functionality:
• Labelling of T1-L4 vertebrae
• Measurement of height loss in
each vertebra (T1-L4)
• Measurement of mean
Hounsfield Units in volume of
interest within vertebra (T11-
L4)
HealthOST is indicated for use in
patients aged 50 and over undergoing
CT scan for any clinical indication that
includes at least two vertebrae in the T1-
L4 portion of the spine (for vertebral
height loss) and/or T11-L4 (for bone
attenuation) portions of the spine.
The device is indicated for FBP-
reconstructed images only.

AI-Rad Companion (Musculoskeletal)
is an image processing software that
provides quantitative and qualitative
analysis from previously acquired
Computed Tomography DICOM
images to support radiologists and
physicians from emergency medicine,
specialty care, urgent care, and general
practice in the evaluation and
assessment of musculoskeletal disease.
It provides the following functionality:
• Segmentation of vertebras
• Labelling of vertebras
• Measurements of heights in each
vertebra and indication if they are
critically different
• Measurement of mean Hounsfield
value in volume of interest within
vertebra.
Only DICOM images of adult patients
are considered to be valid input


Primary Predicate
Device:
AI-Rad Companion
(Musculoskeletal)
(K193267)

Regulation Number
21 CFR §892.1750
21 CFR §892.1750

Deep-learning-based
segmentation of
vertebras

Yes, comparison with
neighboring
measurements
Application of Genant
criteria, indication if
critically different

Yes, comparison with
neighboring
measurements.
Application of Genant
criteria, indication if
critically different

Comparison of Technological Characteristics


HU measurements
based on segmentation
results
Indication to user if
outside reference range

Similar, the subject
device highlights HU
outside of reference
range. This does not
raise new questions of
safety and
effectiveness.

1. Vertebrae
label/name
2. 3 lines representing
the anterior, middle,
and posterior points
measures, together
with relative
measurements
3. % Height loss and
relative Genant
category (20)
4. Bone density
measured in HU

1. Vertebrae
label/name
2. 3 lines representing
the anterior, middle,
and posterior points
measures, together
with relative
measurements
3. Bone density
measured in HU

Similar, new
information does not
raise new questions of
safety and
effectiveness.


Subject Device
Primary Predicate Device
Secondary Predicate Device

Legal Manufacturer
Perspectum Ltd.
Perspectum Ltd.
Inner Vision Biometrics Pty

Proprietary/Common
LiverMultiScan, LMSv5, LMS
LiverMultiScan, LMSv4, LMS
FerriScan

System, Nuclear Magnetic
Resonance Imaging


The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence.


LMSv5 provides several tools, such as
automated liver segmentation and
region of interest (ROI) placements,
to be used for the assessment of
selected regions of an image.
Quantitative assessment of selected
regions includes the determination of
triglyceride fat fraction in the liver
(PDFF), T2*, LIC (Liver Iron
Concentration) and iron corrected T1
(cT1) measurements.
These images and the physical
parameters derived from the images,
when interpreted by a trained
clinician, yield information that may
assist in diagnosis.

LiverMultiScan (LMSv4) provides a
number of tools, such as automated
liver segmentation and region of
interest (ROI) placements, to be used
for the assessment of selected
regions of an image. Quantitative
assessments of selected regions
include the determination of
triglyceride fat fraction in the liver
(PDFF), T2* and iron-corrected T1
(cT1) measurements. T2* may be
optionally computed using the DIXON
or LMS MOST methods.
These images and the physical
parameters derived from the images,
when interpreted by a trained
clinician, yield information that may
assist in diagnosis.

The R2-MRI Analysis System
is an accessory diagnostic
device to MRI scanners and
is intended for diagnostic
use to present images that
reflect the magnetic
resonance spectra for the
determination of iron on the
liver.


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

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

An interpreting clinician or healthcare
practitioner

Installation of LiverMultiScan v5 is
controlled and is installed on general
purpose workstations that meet the
minimum technical requirements at
Perspectum’s image analysis centre
by specialist members of staff.

Installation of LMSv4 is controlled and
is installed on general purpose
workstations that meet the minimum
technical requirements at
Perspectum’s image analysis centre
by specialist members of staff.

Image analysis and LIC
reporting is performed at a
central ISO 13485 certified
Service Centre. Hosting
platform is resonance
health’s internal server.

LiverMultiScan v5 is a standalone
post-processing software device that
is intended to be installed on general
use workstations at Perspectum’s
image analysis centre.
Operators use LMSv5 to conduct
quantitative analysis of liver tissue
characteristics to produce a report.
The end-users for the output from
the device, the report, are clinicians
who receive and interpret
LiverMultiScan (LMSv5) reports.

LMSv4 is a standalone post-
processing software device that is
intended to be installed on general
use workstations at Perspectum’s
image analysis centre.
Operators use LMS to conduct
quantitative analysis of liver tissue
characteristics to produce a report.
The end-users for the output from
the device, the report, are clinicians
who receive and interpret LMSv4
reports.

FerriScan is a standalone
software tool that is
intended to be used by
Resonance Health’s trained
analyst, FerriScan is installed
and runs on the Resonance
Health’s internal server.
The report result is overseen
by the radiologist and the
final decision for clinical
management of the patient
is made by their treating
clinician.


LiverMultiScan v5 is a standalone
software application, it does not
deliver, monitor or depend on energy
delivered to or from patients.

LMS is a standalone software
application, it does not deliver,
monitor or depend on energy
delivered to or from patients.

FerriScan is a standalone
software application. It does
not deliver, monitor or
depend on energy delivered
to or from patients.

LiverMultiScan v5 is a standalone
software application that imports MR
data sets encompassing the
abdomen, including the liver.
Visualisation and display of 2D multi-
slice, spin-echo MR data can be
analysed and quantitative metrics of
tissue characteristics are then
reported.
Datasets imported into
LiverMultiScan (LMSv5) are DICOM
3.0 compliant, reported metrics are
independent of the MRI equipment
vendor.

LMS is a standalone software
application that imports MR data sets
encompassing the abdomen,
including the liver. Visualisation and
display of 2D multi-slice, spin-echo
MR data can be analysed and
quantitative metrics of tissue
characteristics are then reported.
Datasets imported into LMS are
DICOM 3.0 compliant, reported
metrics are independent of the MRI
equipment vendor.

FerriScan is intended for:
• Supporting clinical
diagnoses about the
status of liver iron
concentration.
• Supporting the
subsequent clinical
decision-making
processes.
• Supporting the use in
clinical research trials,
directed at studying
changes in liver iron
concentration as a
result of interventions.
• It contains an image
viewer for importing
DICOM images,
browsing through
patient datasets,
viewing images and
performing region of
interest analysis


Allows for the visualisation via
parametric maps and quantification
of metrics (cT1, LIC and PDFF) from
liver tissue and exportation of results
& images to a deliverable report.
Quantification is through either full
segmentation of the outer liver
contour and liver vasculature or
manual placement of ROI’s on the
parametric maps. IQR and median
metrics are reported from the
segmentation/ROI quantification.
automatically detects artefacts on the
and are delineated on the parametric
map computed images as well as
recommends slices to be used as the
quantitative output of the device.

Allows for the visualisation via
parametric maps and quantification
of metrics (cT1, T2* and PDFF) from
liver tissue and exportation of results
& images to a deliverable report.
Quantification is through either full
segmentation of the outer liver
contour and liver vasculature or
manual placement of ROI’s on the
parametric maps. IQR and median
metrics are reported from the
segmentation/ROI quantification.

Allows for the visualisation
of images that reflect the
magnetic resonance spectra
for the determination of
iron on the liver. It contains
an image viewer for
• importing DICOM
images,
• browsing through
patient datasets,
• viewing images and
performing ROI analysis.

T1, iron corrected T1 (cT1) mapping
and LIC

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

Utilizes MR images that exploit the
difference in resonance frequencies
between hydrogen nuclei in water
and triglyceride fat using the
LiverMultiScan v5 IDEAL method.

Utilizes MR images that exploit the
difference in resonance frequencies
between hydrogen nuclei in water
and triglyceride fat using the LMS
IDEAL method.

Iron corrected T1 (cT1), Proton
Density Fat Fraction (PDFF) and LIC
parametric maps can be created from
all supported scanners.

Iron corrected T1 (cT1), T2* and
Proton Density Fat Fraction (PDFF)
parametric maps can be created from
all supported scanners.

FerriScan calculates the
signal decay rate (R2) that is
used to characterise iron
loading in the liver. It
produces an output report


It is possible to use the LIC maps and
knowledge of the measurements and
the scanner field strength to correct
for signal changes related to iron
deposits, producing a cT1 map. The
cT1 map eliminates the effects of
elevated iron from the T1
measurement (3) and standardizes
for the fat signal across scanner
manufacturers.
PDFF is quantified using the LMS
IDEAL method. Parametric maps of
LIC are quantified using the LMS
MOST method.
LMSv5 uses the measured T2* value
and uses them to characterise iron
loading in the liver which is then
transformed by a defined calibration
curve to provide a quantitative
measure of liver iron concentration in
vivo. LMSv5 presents images that
reflect the magnetic resonance
spectra for iron determination on the
liver.

It is possible to use the T2* and PDFF
maps and knowledge of the T2* and
PDFF measurements and the scanner
field strength to correct for signal
changes related to iron deposits,
producing a cT1 map. The cT1 map
eliminates the effects of elevated iron
from the T1 measurement (3) and
standardizes for the fat signal across
scanner manufacturers.
PDFF is quantified using the LMS
IDEAL method. Parametric maps of
T2* may optionally be computed
using either the three-point DIXON
method or the LMS MOST method.

comprising R2 which is
transformed by a defined
calibration curve into a
quantitative measure of liver
iron concentration in vivo.
FerriScan presents images
that reflect the magnetic
resonance spectra for iron
determination on the liver.

Numerous views within the
LiverMultiScan v5 interface can be
used to assist in analysis of Iron
corrected T1 (cT1), triglyceride fat
(also known as Proton Density Fat
Fraction (PDFF)) and LIC parametric

Numerous views within the LMSv4
interface can be used to assist in
analysis, Iron-corrected T1 (cT1), T2*
and triglyceride fat (also known as
Proton Density Fat Fraction (PDFF))
parametric maps can be created from

Visualisation of multi-slice,
spin-echo MRI data sets
encompassing the
abdomen.
Software tool calculates the
signal decay rate (R2) that is


maps can be created from all
supported scanners.
Parametric maps displayed using the
LMSv5 colourmap, designed to have
maximum contrast on liver
parenchymal tissue.

all supported scanners. R2 maps can
also be utilised to assess the quality
of the map fitting.
Iron- corrected T1 (cT1) displayed
using LMSv4 colourmap, designed to
have maximum contrast on liver
parenchymal tissue.

used to characterise iron
loading in the liver, which is
then transformed by a
defined calibration curve to
provide a quantitative
measure of liver iron
concentration in vivo.
LIC is displayed on a map
and histogram within the
FerriScan LIC report.

DICOM 3.0 compliant MR data from
supported MRI scanners.

DICOM Image Format.
Functionality independent
of MRI equipment vendor.


Results over the validation set compared to the reference device are presented here:


510(k) Number
Product Code
Trade Name
Manufacturer

K192692
LLZ
Brainomix 360° e-CTA
Brainomix Limited


Characteristics
Predicate Device
Subject Device

Table 2 Technological Characteristics Comparison Table


Brainomix 360° e-CTA is a
software package that provides
for the study of changes of
tissue in digital images
captured by CT. Brainomix
360° e-CTA provides viewing
and quantification for CTA
images.

CerebralGo Plus is a software
package that provides for the
visualization digital images
capture by
CTA.

Brainomix 360° e-CTA is an
image processing software
package to be used by trained
professionals, including, but
not
limited to physicians and
medical technicians. The
software runs on standard “off-
the-shelf” hardware (physical
or virtualized) and can be used
to perform image viewing,
processing and analysis of
images. Data and images are
acquired through DICOM
compliant imaging devices.
Brainomix 360° e-CTA
provides viewing and analysis
capabilities for imaging
datasets acquired with CTA
(CT Angiography).
Brainomix 360° e-CTA is not
intended for mobile diagnostic
use.

CerebralGo Plus is an image
processing software package to be
used by trained professionals,
including, but not limited to
physicians and medical
technicians. The software runs on
standard “off-the-shelf” hardware
and can be used for image
viewing and processing. Data and
images are acquired through
DICOM compliant imaging
devices.
CerebralGo Plus provides
viewing and processing
capabilities for imaging datasets
acquired with adult’s CTA (CT
Angiography).
CerebralGo Plus is not intended
for primary diagnostic use.

Environment of Use
Clinical/Hospital Environment
Clinical/Hospital Environment

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

End User
Trained clinicians
Trained clinicians

CerebralGo Plus, Yukun (Beijing) Technology Co., Ltd.


Supported Modalities
for image processing
and visualization

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

Standard Physical and Virtual
off-the shelf Server

Acquires medical image data
from DICOM compliant
imaging devices and
modalities

CTA modality
CTA large vessel
CTA large vessel

Stand-alone software
performance testing


Subject Device
Primary Predicate
Secondary Predicate
Tertiary Predicate

Manufactured by Circle
Manufactured by Circle
Manufactured by Circle
Manufactured by Circle

Viewing, post-processing,
qualitative and quantitative
evaluation of cardiovascular MR
images in DICOM format.

Viewing, post-processing,
qualitative and quantitative
evaluation of cardiovascular CT
images in DICOM format.

qualitative and quantitative
qualitative and quantitative
qualitative and quantitative
qualitative and quantitative

evaluation of blood vessels and
evaluation of cardiovascular MR
evaluation of blood vessels and
evaluation of cardiovascular CT

cardiovascular MR and CT images
images in DICOM format.
cardiovascular MR and CT images
images in DICOM format.

cmr42 is intended to be used for
viewing, post-processing and
quantitative evaluation of
cardiovascular magnetic resonance
(MR) images in a Digital Imaging
and Communications in Medicine
(DICOM) Standard format.
It enables;
• Importing Cardiac MR Images in
DICOM format
• Supporting clinical diagnostics by
qualitative analysis of the cardiac
MR images using display
functionality such as panning,
windowing, zooming, navigation
through series/slices and phases.
• Supporting clinical diagnostics by
quantitative measurement of the
heart and adjacent vessels in
cardiac MR images, specifically
distance, area, volume and mass
• Supporting clinical diagnostics by
using area and volume
measurements for measuring LV
function and derived parameters
cardiac output and cardiac index in
long axis and short axis cardiac MR
images.
• Flow quantifications based on
velocity encodes images

for viewing, post-processing,
an image analysis software
viewing, post-processing and

qualitative and quantitative
package add-on for evaluating CT
quantitative evaluation of

evaluation of cardiovascular
and MR images of blood vessels.
cardiovascular computed

magnetic resonance (MR) and
Combining digital image processing
tomography (CT) images in a

computed tomography (CT) images
and visualization tools such as
Digital Imaging and

in a Digital Imaging and
multiplaner reconstruction (MPR),
Communications in Medicine

Communications in Medicine
thin/think maximum intensity
(DICOM) Standard format.

(DICOM) Standard format.
projection (MIP) thin and think,
It enables:

inverted MIP thin and think, volume
• Importing Cardiac CT Images in

It enables a set of tools to assist
rendering technique (VRT), curved
DICOM format

physicians in qualitative
planner reformation, processing
• Supporting clinical diagnostics by

assessment of cardiac images and
tools such as bone removal (based
qualitative analysis of the cardiac

quantitative measurements of the
on both single energy and dual
CT images using display

heart and adjacent vessels;
energy) table removal and
functionality such as panning,

perform calcium scoring; and to
evaluation tools (vessel centerline
windowing, zooming, navigation

confirm the presence or absence of
calculation, lumen calculation,
through series/slices and phases,

physician-identified lesion in blood
stenosis calculation) and reporting
3D reconstruction of images

vessels.
tools (lesion location, lesion
including multi-lanner

characteristics) and key images),
reconstructions of the images.

The target population for cvi42
the software package is designed
• Supporting clinical diagnostics by

Auto’s manual workflows is not
to support the physician in
quantitative measurement of the

restricted; however, cvi42 Auto’s
conforming the presence or
heart and adjacent vessels in

semi-automated machine learning
absence of physician identified
cardiac CT images, specifically

algorithms are intended for an adult
lesion in blood vessels and
distance, area, volume and mass

population.
evaluation, documentation and
• Supporting clinical diagnostics by

follow up of any such lesions.
using area and volume

cvi42 Auto shall be used only for
measurements for measuring LV

cardiac images acquired from an
It shall be used by qualified medical
function and derived parameters

MR or CT scanner. It shall be used
professionals, experienced in
cardiac output and cardiac index in

by qualified medical professionals,
examining and evaluating
long axis and short axis cardiac CT

experienced in examining and
cardiovascular CT or MR images,
images.

Table 1. Comparison to the predicate devices.


Subject Device
Primary Predicate
Secondary Predicate
Tertiary Predicate

Manufactured by Circle
Manufactured by Circle
Manufactured by Circle
Manufactured by Circle

evaluating cardiovascular MR or
CT images, for the purpose of
obtaining diagnostic information as
part of a comprehensive diagnostic
decision-making process.

It shall be used by qualified medical
professionals, experienced in
examining and evaluating
cardiovascular MR images, for the
purpose of obtaining diagnostic
information as part of a
comprehensive diagnostic decision-
making process. cmr42 is a software
application that can be used as a
stand-alone product or in a
networked environment.
The target population for the cmr42
is not restricted, however the image
acquisition by a cardiac magnetic
resonance scanner may limit the
use of the device for certain sectors
of the general public.
cmr42 shall not be used to view or
analyze images of any part of the
body except the cardiac magnetic
resonance images acquired from a
cardiovascular magnetic resonance
scanner.

for the purpose of obtaining
diagnostic information as part of a
comprehensive diagnostic decision-
making process. cvi42 is a software
application that can be used as a
stand-alone product or in a
networked environment.
The target population for the cvi42
is not restricted.

CT images, for the purpose of
professionals, experienced in
diagnostic information as part of a
quantitative measurements of

obtaining diagnostic information as
examining and evaluating
comprehensive diagnostic decision-
calcified plaques in the coronary

part of a comprehensive diagnostic
cardiovascular MR images, for the
making process. cvi42 is a software
arteries (calcium scoring),

decision-making process.
purpose of obtaining diagnostic
application that can be used as a
specifically Agatston and volume

information as part of a
stand-alone product or in a
and mass calcium scores

comprehensive diagnostic decision-
networked environment.

making process. cmr42 is a software
It shall be used by qualified

application that can be used as a
The target population for the cvi42
medical professionals, experienced

stand-alone product or in a
is not restricted.
in examining and evaluating

networked environment.
cardiovascular CT images, for the

The target population for the cmr42
information as part of a

is not restricted, however the image
comprehensive diagnostic

acquisition by a cardiac magnetic
decision-making process. ct42 is a

resonance scanner may limit the
software application that can be

use of the device for certain sectors
used as a stand-alone product or

of the general public.
in a networked environment.

cmr42 shall not be used to view or
The target population for the ct42 is

analyze images of any part of the
not restricted, however the image

body except the cardiac magnetic
acquisition by a cardiac CT

resonance images acquired from a
scanner may limit the use of the

cardiovascular magnetic resonance
device for certain sectors of the


Feature
Subject Device
Primary Predicate
Secondary Predicate
Tertiary Predicate

Manufactured by Circle
Manufactured by Circle
Manufactured by Circle
Manufactured by Circle

Device Classification
QIH, LLZ
LLZ
LLZ
LLZ

Picture Archiving and
Communications System

and processing system
Communications System
Communications System

Imaging Modalities
MR and CT
MR
MR and CT
CT

Import and display
Yes
Yes
Yes (MR only)
Yes (MR only)
Yes
Yes
Yes (CT only)

Post process CMR/CCT
Yes
Yes (MR only)
Yes
Yes (CT only)

Multiplanar Reformat
Yes
Yes
No
No
Yes
Yes
Yes

Navigation Tools
Navigation Tools
Panning,
Panning,

Series/slices and phases
Series/slices and phases

Quantitative assessment
of cardiac function

Manual segmentation of four
heart chambers in long and
short-axis views

Manual segmentation,
and semi-automatic
segmentation of four
heart chambers in long
and short-axis views

Manual segmentation,
and semi-automatic
segmentation of four
heart chambers in short-
axis views

semi-automatic segmentation
heart chambers in long and

Cells marked as N/A are features already supported by the primary predicate.


Centerline placement in
coronary vessels

using Machine Learning
automatic
automatic

Calcium Scoring
Yes, using ML methodology
Yes, using ML methodology
No
No
Yes, using non-ML

Workstation operating
macOS,
macOS,
macOS,
macOS,

system
Microsoft Windows
Microsoft Windows
Microsoft Windows
Microsoft Windows


Predicate Device
DLIR for Revolution CT (K183202)

DLIR uses a dedicated Deep Neural
Network (DNN) which is trained on the
CT scanner and therefore models the
propagation of noise through the system
to identify and remove the noise

Same DNN technology with
revised network
architecture with retraining
and inferencing techniques

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

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

System statistics – Noise
characteristics of the
reconstructed images

DLIR uses a trained DNN which models
the scanned object using information
obtained from extensive phantom and
clinical data to identify the noise
characteristics and remove it

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

similarities and differences between the predicate device and the proposed device:


syngo.CT Extended Functionality
(SOMARIS/8 VB60)

syngo.CT Extended Functionality
(SOMARIS/8 VB51)

The trauma reading plugin allows the user
convenient sorting of a large number of
reconstruction series and displays them
into body region specific layouts. The
features are:
• Set of pre-configured layouts for
reading trauma reconstructions.
• The reconstruction series
corresponding to different body regions
are assigned to body region specific
layouts.

Display different representations of Dual
Energy data.
Modifications:
The software has been modified to:
• accept and display additional data sets
received from CT scanners, and
• display mean values of ROIs in addition
to the measured values.

The user can perform a vascular
evaluation supporting the following main
functionalities:
• Measuring vessels
• Creating DICOM snapshots or result
series for documenting findings
• Working on images that are acquired
with CT or MR scanner systems
constituting one or more volumes of
vascular structures
Modification:
Support for display and processing of
images > 512x512.


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

Medical Device Software –Software Life Cycle
Processes; 62304:2006 (1st Edition)/A1:2016

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

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


Characteristic
Subject Device
Predicate Device
Reference Device
Reference Device

Device Name
AVIEW
AVIEW
ClariCT.AI
Broncholab

Review Panel
Review Panel
Radiology
Radiology
Radiology
Radiology

software can be used to support the physician providing quantitative analysis of CT images by

image segmentation of sub-structures in the lung, lobe, airways, fissures completeness, cardiac,

density evaluation, and reporting tools. AVIEW is also used to store, transfer, inquire and

display CT data set on-premises and as a cloud environment to allow users to connect by

various environments such as mobile devices and Chrome browsers. Converts the sharp kernel

to soft kernel for quantitative analysis of segmenting low attenuation areas of the lung.

Characterizing nodules in the lung in a single study or over the time course of several thoracic

studies. Characterizations include nodule type, location of the nodule, and measurements such

as size (major axis, minor axis), estimated effective diameter from the volume of the nodule,

the volume of the nodule, Mean HU(the average value of the CT pixel inside the nodule in

HU), Minimum HU, Max HU, mass(mass calculated from the CT pixel value), and volumetric

measures(Solid major; length of the longest diameter measure in 3D for a solid portion of the

nodule, Solid 2nd Major: The size of the longest diameter of the solid part, measured in sections

perpendicular to the Major axis of the solid portion of the nodule), VDT (Volume doubling

time), and Lung-RADS (classification proposed to aid with findings.) ). The system

automatically performs the measurement, allowing lung nodules and measurements to be

displayed and, integrate with FDA certified Mevis CAD (Computer aided detection)

(K043617). It also provides the Agatston score, volume score, and mass score by the whole and

each artery by segmenting four main arteries (right coronary artery, left main coronary, left

anterior descending, and left circumflex artery). Based on the calcium score provides CAC risk

AVIEW provides CT values for pulmonary tissue from CT thoracic and cardiac datasets. This
software could be used to support the physician quantitatively in the diagnosis, follow up

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