Items (fetal ultrasound views detected)
Sensitivity
Specificity

AI-1 High Level Anatomy:
Fetal “Abdomen” View
Detection across any of:
(“Bladder Plane ”,, “Kidneys Plane”, “Stomach
Umbilical Plane“, “Cord Insertion Plane”)

AI-1 High Level Anatomy:
Fetal “Face” View,
Detection across any of:
(“Median Facial Profile Plane”, “Coronal Plane of
Upper Lip, Nose, and Nostrils Plane”, “Orbits,
Lenses Plane”)

AI-1 High Level Anatomy:
Fetal “Head” Planes,
Detection across any of:
(“Transthalamic Plane”, “Transventricular Plane”,
“Transcerebellar Plane”)

AI-1 High Level Anatomy:
Automatic detection of the Fetal “Limbs”
characterized across, 10 potential visual elements
Detection across any of:
-tibia
-fibula
-foot
-ankle region, “relationship between the tibia,
fibula, and foot”
-humerus
-radius
-ulna
-wrist region, “relationship between the hand,
radius, and ulna”
-hand
-femur

Table 5: Results of Standalone Performance Testing for AI-1: High-Level Anatomy Classification


Items (fetal ultrasound
views,
anatomical structures
and
characteristics
automatically
detected)

Sensitivity Across
Diagnostically
Acceptable Images

Automatic detection of 5
High-Level Fetal
Anatomy Sections
(Abdomen, Face, Head,
Limbs, Thorax)

Automatic detection of 13
fetal ultrasound planes
(Per-class Top-1
classification)

Automatic detection of 12
fetal head
anatomical structures on
the views
“Transthalamic”,
“Transventricular”,
“Transcerebellar”

Automatic detection of 9
fetal abdomen
anatomical structures on
the views
“Bladder”,
“Kidneys”,
“Stomach Umbilical
Vein”,
“Cord Insertion”

Automatic detection of 9
fetal face
anatomical structures on
the views
“Coronal Plane of Upper
Lip, Nose, and Nostriles”,
“Median Facial Profile”,
“Orbits, Lenses”

Top-1 Fetal Plane Classification”, and “AI-3: Fetal Anatomical Structure Classification”


anatomical structures on
the views
“Sagittal Spine”

Automatic detection of 16
fetal thorax and heart
anatomical structures on
the views
“Four Chamber”,
“LVOT”,
“RVOT”,
“3VV”,
“3VT”


IEC 60601-2-37 (ed.2), am1 for use in conjunction with IEC60601-
1 (ed.3), am1 with Corr1 and Corr2

ISO 10993-1:2018, Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management process

applications comply with the following FDA-recognized standards.


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

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

510(k) Premarket Notification – Traditional


In accordance with 21 CFR 80
7.87(h) and 21 C

Classification Regulation
2
1 CFR 892.2070

Predicate Device: K232384
VideaHealth’s Vi


VideaHealth, Inc.
179 South Street, Floor 5
Boston, MA, 02111
+1 617-340-9940
florian@videa.ai

Adam Foresman
Director of Quality & Regulatory Affairs
VideaHealth, Inc.
+1 617-340-9940
adam@videa.ai


Classification Name:
Medical image analyzer


Caries
3 years and older
Bitewing and Periapical

Attrition
3 years and older
Bitewing and Periapical

Table 1: VDA Indications Scope by Patient Age and Image Modality Type


Broken/Chipped
3 years and older
Bitewing and Periapical

Restorative Imperfection
3 years and older
Bitewing and Periapical

12+ years of age and
older with permanent
dentition

Dens Invaginatus
3 years & older
Bitewing and Periapical

22 years of age and
older with permanent
dentition

Calculus
3 years and older
Bitewing and Periapical

Widened PDL
3 years and older
Bitewing and Periapical

All on Bitewing,
Periapical & Panoramic
except:
1.‘Screw’ VDA
historical treatment
identification is only on
Panoramic images.
2.‘Plate’ VDA historical
treatment indication is
only on Panoramic
images.

1. Impacted Tooth
2. Mental Foramen
3. Maxillary Tuberosity
On Bitewing, Periapical
& Panoramic


All other indications are
on Bitewing, Periapical
& Panoramic except:
1.‘Mandibular Condyle’
VDA normal anatomy
indication is only on
Panoramic images.


Applicant
VideaHealth, Inc.
VideaHealth, Inc.

Device Name
Videa Dental AI
Videa Dental Assist

Bitewing Images, Periapical
Images, and Panoramic
Images.
Radiograph view type scope is
Videa Dental Assist indication
specific.

Caries: Active and Secondary
Caries at all penetration depths
Additional Suspect Dental
Findings listed in the Videa
Dental Assist’s Indications For
Use statement.

Historical Treatment and
Normal Anatomy
Indications

For the caries indication only:
Proximal, Buccal/Lingual,
Occlusal, Root, Cervical.
None of the additional VDA
‘Suspect Dental Finding’
indications are specific to a
tooth surface.


Message indicating if and how
many findings were detected
for each enabled Videa Dental
AI’s indication for use.
All Videa Dental AI’s
indications use a set of
togglable bounding boxes
around suspected areas of
interest.
The user has the option to
toggle to segmentation view
(also called isocontour view)
instead of bounding boxes for
caries and calculus.
The user has the option to
toggle between operating
points (high sensitivity vs.
high specificity) for a caries
and periapical radiolucency.
The user has the option to
toggle normal tooth anatomy
segmentations including
enamel, pulp, crown dentin
and root dentin on and off.

Message indicating if and how
many findings were detected
for each enabled Videa Dental
Assist’s indication for use.
All Videa Dental Assist’s
indications use a set of
toggleable bounding boxes
around suspected areas of
interest.

Patients ≥ 3 years of age.
Patient age range is Videa
Dental Assist indication
specific.

Intended User
Dental professionals
Dental professionals

Development Technology
Supervised Deep Learning
Supervised Deep Learning


Table 6: Image breakdown by radiographic view


The volume of calcified plaque (CP) in a lesion or all the lesions
in a vessel.

• On Screen Data Panel
• Coronaries (Plaque)
Module Report

The volume of non-calcified plaque (NCP) in a lesion or all the
lesions in a vessel.

Low-Attenuation Plaque
(LAP) Volume [mm3]

The volume of low-attenuation plaque (LAP) in a lesion or all
the lesions in a vessel; LAP volume is also included in NCP
volume.

The volume of total plaque including CP and NCP (with LAP) in
a lesion or all the lesions in a vessel.

The burden of CP in a lesion or the whole vessel; obtained by
dividing the CP volume by the lesion vessel wall or entire vessel
volume, as appropriate.

The burden of NCP in a lesion or the whole vessel; obtained by
dividing the NCP volume by the lesion vessel wall or entire
vessel volume, as appropriate.

The burden of LAP in a lesion or the whole vessel; obtained by
dividing the LAP volume by the lesion vessel wall or entire
vessel volume, as appropriate.

The burden of total plaque in a lesion or the whole vessel;
obtained by dividing the total plaque volume by the lesion
vessel wall or entire vessel volume, as appropriate.

A measure of enlargement of vessel dimensions to
accommodate plaque development compared to normal vessel
sections; it is expressed as the ratio of the largest diameter
across the lesion and reference diameter (or maximum vessel
wall cross-sectional area and reference vessel wall cross-
sectional area).

Stenosis expressed as the percent amount of reduced lumen
diameter compared with reference diameter.

Stenosis expressed as the percent amount of reduced lumen
area compared with reference area.

Table 1. Measurements in the Coronary Plaque Module


Secondary Predicate
Cleerly Labs (K190868)
Manufactured by Cleerly Inc

Coronary Plaque Module
cvi42 Auto (K213998)

Manufactured by Circle
Manufactured by Circle

Cardiovascular Imaging Inc.
Cardiovascular Imaging Inc.

Device Class
II
II
II
Same as predicate device(s)

Same as primary predicate device,
secondary predicate uses AI/ML
functionality.

Medical image management and
processing system

Picture archiving and
communications system

Regulation Number
21 CFR § 892.2050
21 CFR § 892.2050
21 CFR § 892.2050
Same as predicate device(s)

Same as primary predicate device.
Core functionality of subject
device unaffected by OS. No
safety or effectiveness concerns
.

Same as the predicate device(s)
with the exception that the primary
predicate also allows MR inputs.

DICOM Compliant
Yes
Yes
Yes
Same as predicate device(s)

Import and display CT images
Yes
Yes
Yes
Same as predicate device(s)

Post process CCT images
Yes
Yes
Yes
Same as predicate device(s)

Images can be displayed by
study and series

2D Imaging
Yes
Yes
Yes
Same as predicate device(s)

2D Measurement
Yes
Yes
Yes
Same as predicate device(s)

3D Imaging
Yes
Yes
Yes
Same as predicate device(s)

Table 3. Regulatory and technological features comparison.


Multiplanar reformatting (MPR)
Yes
Yes
Yes
Same as predicate device(s)

Manual and Semi-Automatic (using
Machine Learning technique)
Segmentation of Coronary Vessels,
Including Lumen and Vessel Wall
Structures.

Manual and Semi-Automatic (using
Machine Learning technique)
Centerline Generation of the
Coronary Vessels.

Manual and Semi-Automatic (using
Machine Learning Technique)
Segmentation of Coronary Vessels,
Including Lumen and Vessel Wall
Structures.

Same as the predicate device(s),
with the exception that the primary
predicate does not offer
segmentation of the lumen and
vessel wall structures.
The successful passing of the
V&V performance testing has
demonstrated that the addition of
semi-automatic segmentation of
the lumen and vessel wall
structures does not raise new
questions of safety.

Both the subject device and
secondary predicate device
provide plaque thresholds.

Signal Density [HU]
Yes
Yes
Yes
Same as predicate device(s)

Distance Measurements
(Vessel, Lesion, Length) [mm]

- Non-Calcified Plaque (NCP)
- Low-Attenuation Plaque (LAP)
- Calcified Plaque (CP)
- Total Plaque

- Total Vessel
- Total Lumen
- Non-Calcified Plaque (NCP)
- Low-Density Non-Calcified Plaque
(LD-NCP)
- Calcified Plaque (CP)
- Total Plaque

The subject device and the
secondary predicate display the
same measurements, with the
exception of Total Vessel and
Total Lumen – which are
calculated but not reported as a
device output.

- Diameter-Based Stenosis
- Area-Based Stenosis


(PCC). All performance testing results met Circle’s pre-defined acceptance criteria.


431 Florence Street
Suite 100
Palo Alto, CA 94301

James Jochen Rogers
FDA Regulatory Affairs, Quality Assurance, and Clinical Studies
T: 724.713.2298
E: jr@vista.ai


Trade / Proprietary Name
Vista OS, Vista AI Scan, RTHawk

Magnetic resonance diagnostic device (MRDD)

System, Nuclear Magnetic Resonance Imaging


510(k) #
Device
510(k) Sponsor
Clearance Date

K212233
RTHawk, HeartVista Cardiac Package
HeartVista, Inc.
October 5, 2021


Operating Modes
IEC 60601-2-33 1st Level Operating Mode

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


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

Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance; Section 14 Programmable
Electrical Medical Systems (PEMS)

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

Determination of Image Uniformity in Diagnostic Magnetic
Resonance Images

Acoustic Noise Measurement Procedure for Diagnostic Magnetic
Resonance Imaging Devices

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

Digital Imaging And Communications In Medicine (DICOM) Set

Medical Devices - Application Of Risk Management To Medical
Devices

table below, as applicable to device features and components:


Attribute
RTHawk 3.0.0, K212233
RTHawk 3.3.0: Subject Device

Device Name
RTHawk, HeartVista Cardiac Package
Vista OS, Vista AI Scan, RTHawk

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

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

The following compares the modified device to the predicate device K212233:


spin-spin relaxation time (T2) and flow. When
interpreted by a trained physician, these
images provide information that may assist in
the determination of a diagnosis.
RTHawk is intended for use as an accessory to
the following MRI systems:
Manufacturers: GE Healthcare (GEHC),
Siemens Healthineers
Field Strengths: 1.5T and 3.0T
GE Software Versions: 12, 15, 16, 23, 24, 25,
26
Siemens Software Versions: N4/VE; NX/VA

images provide information that may assist in
the determination of a diagnosis.
Vista OS is intended for use as an accessory to
the following MRI systems:
Manufacturers:: GE Healthcare (GEHC),
Siemens Healthineers
Field Strength:: 1.5T and 3.0T
GE Software Versions:: 12, 15, 16, 23, 24, 25,
26, 30
Siemens Software Versions:: N4/VE; NX/VA

Transverse, Coronal, Sagittal, Oblique,
Double Oblique

Cardiac T2* Map Spiral
Cardiac T2* Map Spiral

Cardiac T2* Map Cartesian
Cardiac T2* Map Cartesian


Multi-Slice Cine Flow
Multi-Slice Cine Flow

Stack of Spiral Cine Flow
Stack of Spiral Cine Flow


Specification
Subject Device
Predicate Device
Comparison

Syngo Carbon Clinicals is intended to provide
advanced visualization tools to prepare and process
the medical image for evaluation, manipulation and
communication of clinical data that was acquired by
the medical imaging modalities (for example, CT,
MR, etc.)
OrthoMatic Spine provides the means to perform
musculoskeletal measurements of the whole spine, in
particular spine curve angle measurements.
The TimeLens provides the means to compare a
region of interest between multiple time points.
The software package is designed to support
technicians and physicians in qualitative and
quantitative measurements and in the analysis of
clinical data that was acquired by medical imaging
modalities.
An interface shall enable the connection between the
Syngo Carbon Clinicals software package and the
interconnected software solution for viewing,
manipulation, communication, and storage of medical
images.

Syngo Carbon Clinicals is intended to provide
advanced visualization tools to prepare and process the
medical image for evaluation, manipulation and
communication of clinical data that was acquired by
the medical imaging modalities (for example, CT,
MR, etc.)
The software package is designed to support
technicians and physicians in qualitative and
quantitative measurements and in the analysis of
clinical data that was acquired by medical imaging
modalities.
An interface shall enable the connection between the
Syngo Carbon Clinicals software package and the
interconnected software solution for viewing,
manipulation, communication, and storage of medical
images.

Indications adapted to
include the new features

Syngo Carbon Clinicals is not indicated for
mammography images for diagnosis in the U.S.
Syngo Carbon Clinicals is not to be used as a sole
basis for clinical decisions


Syngo Carbon Clinicals has architecture that is based
on a layered pattern where the various clinical
tools/functionality are decomposed into
modules/common tools which provide their
individual functionalities.

Syngo Carbon Clinicals relies on the interfacing
application for Image communication.

Measurement,
Evaluation/Interpr
etation
Tools

• Oncological evaluation:
Lesion Quantification
o
Assisted Perpendicular Tool
o
Lung Nodule Marker
o
Time Lens
o
• Orthopaedic measurements:
Manual calibration
o
OrthoMatic Spine
o

• Oncological evaluation:
Lesion Quantification
o
Assisted Perpendicular Tool
o
Lung Nodule Marker
o
• Orthopaedic measurements:
Manual calibration
o

Time Lens tool enables
comparison of a region of
interest between multiple
timepoints.
OrthoMatic Spine tool
provides automated
calculation of spine
measurements in CR and
DX images.

DICOM image object display
• CT Image
• DX Image
• CR Image


None
Syngo Carbon Clinicals relies on the interfacing
application for operating system.

None
Syngo Carbon Clinicals provides advanced
visualization tools to prepare and process the
medical images and it has no influence on the image
acquisition devices

None
No automated diagnostic interpretation capabilities
like CAD are included. All image data are to be
interpreted by trained personnel.

Clinical condition
the device is
intended to
diagnose, treat, or
manage

No limitation on the clinical condition
of the patient

No limitation concerning the patient
population (e.g., age, weight, health,
condition)

Site of the body
the device is
intended to be
used

No limitation concerning region of
body or tissue type

Syngo Carbon Clinicals offers a wide range of tools
from the major clinical fields, i.e. general radiology,
oncology environments.

Device Type
Software application
Software application
Same


Specification
Subject Device
Predicate Device
Comparison

The cybersecurity aspects for Syngo Carbon
Clinicals is handled by the interfacing/hosting
system.

Not offered by Syngo Carbon Clinicals, it relies on
the hosting applications

Printing
Not offered by Syngo Carbon Clinicals
Not offered by Syngo Carbon Clinicals
Same

Yes, with search, indexing, filtering, library function
and document collections


DHT8B: Division of Radiological Imaging Devices and


BrightHeart
7-11 boulevard Haussmann
Paris 75009, France

Christophe Gardella
Chief Technical Officer
Tel. +0033686543950
Email. christophe@brightheart.fr

Submission Correspondent:
Christophe Gardella


Device Common Name:
Medical image analyzer

Radiological computer-assisted diagnostic software for
lesions suspicious for cancer 21 CFR 892.2060


Software algorithm
Machine Learning Model
Machine Learning Model

Imaging Modality
Fetal Ultrasound
Fetal Ultrasound

Fetal ultrasound study containing
the following views: 4 chamber, left
ventricular outflow tract, right
ventricular outflow tract

Suspicious radiographic findings
categorized into 2 groups:
● “classification” features are
based on the identification of
morphological features within
the video clip.
● “measurement” features are
based on the detection and
segmentation of key anatomic
points

Identifiable suspicious radiographic
findings of the fetal heart
● overriding artery
● septal defect at the cardiac crux
● abnormal relationship of the
outflow tracts
● enlarged cardiothoracic ratio
● right ventricular to left
ventricular size discrepancy
● tricuspid valve to mitral valve
annular size discrepancy
● pulmonary valve to aortic valve
annular size discrepancy
● cardiac axis deviation

For each frame the software
evaluates whether the findings are:
present, absent, or inconclusive.
A “record summary table” displays
a summary of results for each video
clip. An “exam summary table”
displays a summary of the results for
the overall study.


● Annotated DICOMs within the
user PACS viewer
● Device web interface


analyzed finding but possibly positive to other findings.


3. Anatomy Segmentation : This study assessed the ability of Segmentron Viewer to segment 8

anatomical structures in 56 CBCT scans. Across all anatomical structures, Segmentron

demonstrated strong segmentation agreement with the reference standard. The primary

endpoint was met, as the Dice Coefficients for each anatomical region exceeded their

4. Labeling Performance: This study aimed to validate the accuracy of labels automatically

generated by the device for teeth, anatomical structures, and pulp on 40 CBCT scans from the

larger validation dataset. Across all teeth, pulp, and anatomical structures in all CBCT scans,

Segmentron Viewer achieved a labeling accuracy of 100%, demonstrating strong concordance

between the labels automatically generated by the device and those determined by an expert


Criteria
Subject Device: Segmentron Viewer
Predicate Device: Ez3D-i /E3 (K231757)
Comparison

Automated radiological image processing software

Segmentron Viewer is a software product intended
for processing and manipulating maxillofacial
radiographic images. Segmentron Viewer allows
users to perform the following functions:
1. Viewing patient images (provides tools for image
processing and viewing functions);
2.Reading and 3D visualization of CBCT images;
3. Generating editable 3D STL files (for educational
purposes only).
The device is indicated for use by medical
professionals (such as dentists and radiologists), in
patients 14 years and older with permanent teeth.
Segmentron Viewer is a web application. It can be
used in a network environment.

Ez3D-i/E3 is dental imaging software that is intended to provide
diagnostic tools for maxillofacial radiographic imaging. These
tools are available to view and interpret a series of DICOM
compliant dental radiology images and are meant to be used
by trained medical professionals such as radiologist and
dentist.
Ez3D-i/E3 is intended for use as software to load, view and
save DICOM images from CT, panorama, cephalometric and
intraoral imaging equipment and to provide 3D visualization, 2D
analysis, in various MPR (Multi-Planar Reconstruction)
functions

Same intended
use. The minor
differences in
indications for use
do not raise
different questions
of safety or
effectiveness or
alter the
fundamental
clinical purpose.

(cid:120) View and save images from CBCT scanners
(cid:120) Image measurement
(cid:120) Multi-Planar Reconstruction (MPR) functions
(cid:120) 3D image viewing and reformation
(cid:120) Rendering functions, e.g., MPR and 3D rendering
(visualization), 3D zoom
(cid:120) Image segmentation
(cid:120) Export capabilities
(cid:120) Generates reports
(cid:120) Manage and add objects
(cid:120) Image manipulation (e.g., magnify, hue,
brightness)
(cid:120) Image annotation
(cid:120) Cloud-based storage

(cid:120) View and save images from CT, panorama, cephalometric

Both are AI-
based, software-
only devices
providing tools for
viewing/evaluating
pre-existing
maxillofacial
radiographic
images. The
differences in
specific functions
do not raise
different
questions.

(cid:120) 3D image viewing and reformation (including canal

(cid:120) Rendering functions, e.g., Volume Rendering, MIP, miniIP,

(cid:120) Manage and add objects, color maps, fine tuning

(cid:120) Implant simulation tools for treatment planning

Algorithm
Supervised machine learning
Supervised machine learning
Same

Configuration
Web application
Desktop application
Similar


APEX Software for QDR X-Ray Bone Densitometers


Manufacturer
EOS imaging
Hologic
EOS imaging

System
VEA Align (K251747)
APEX Software for QDR X-
AutoDensity

Product Code
QIH
KGI
QIH
Yes, same as predicate

Device Classification
II
II
II
Yes, same as predicate

Medical Image Management and
Processing System

This cloud-based software is
intended for orthopedic
applications in both pediatric and
adult populations.
2D X-ray images acquired in
EOS imaging’s imaging systems
is the foundation and resource to
display the interactive landmarks
overlayed on the frontal and
lateral images.
These landmarks are available
for users to assess patient-
specific global alignment.
For additional assessment,
alignment parameters compared
to published normative values
may be available.
This product serves as a tool to
aid in the analysis of spinal
deformities and degenerative
diseases, and lower limb
alignment disorders and
deformities through precise angle
and length measurements. It is

The APEX for QDR X-Ray Bone
Densitometers is indicated for
the estimation of bone mineral
density (BMD), comparison of
measured variables obtained
from a given QDR scan to a
database of reference values,
the estimation of fracture risk,
vertebral deformity assessment,
body composition analysis, and
discrimination of bone from
prosthetics using the Hologic
QDR® X-Ray Bone
Densitometers.
IVA scans are intended for the
visualization or quantitative
assessment of vertebral body
deformities. IVA also allows the
visualization of abdominal aortic
calcifications and, if present,
clinical correlation may be
advised since abdominal aortic
calcification may be associated
with cardiovascular disease.

AutoDensity is a post-processing
software intended to estimate
spine Bone Mineral Density
(BMD) from EOSedge dual
energy images for orthopedic
pre-surgical assessment
applications. It is an
opportunistic tool that enables
immediate assessment of bone
density from EOSedge images
acquired for other purposes.
AutoDensity is not intended to
replace DXA screening.
Suspected low BMD should be
confirmed by a DXA exam.
Clinical judgment and experience
are required to properly use the
software.

Yes, the subject device intended
use/indications for use are
substantially equivalent to the
predicate device as both devices
intended/indicated to provide clinical
parameters from X-ray images
acquired by EOS imaging system
(EOSedge) for orthopedic pre-
surgical assessment applications
(alignment parameters for the
predicate and BMD for the subject
device).


suitable for use with adult and
pediatric patients aged 7 years
and older.
Clinical judgment and experience
are required to properly use the
software

VEA Align is contraindicated for
cases with vertebrae with severe
congenital deformities (e.g.,
hemivertebrae, spina bifida, etc.).

Pregnancy and the use of
contrast agents within the past 7
days are contraindicated.

AutoDensity is contraindicated
for cases with supernumerary/
missing vertebrae.

Yes, the updated contraindications
do not change the Intended Use.
Both devices treat the same patient
population and compute clinical
parameters from X-ray images
acquired by EOSedge system for
orthopedic applications.
While contraindications are
different, this is not critical to the
proposed device's functionality.

AutoDensity software runs in a
cloud-environment.

APEX software runs on QDR X-
Ray Bone Densitometers.

VEA Align generates spine
landmarks from 2D X-ray images
acquired with EOSedge system,
used to compute alignment
clinical parameters.

The Hologic APEX software
generates a range of reports and
images utilizing the DXA data
acquired with the Hologic QDR
systems. It can display the DXA
measurements along with a
representative color image
mapping of bone and soft tissue.

AutoDensity generates bone
mineral density information
utilizing the dual-energy images
acquired with the EOSedge
system. It computes bone
mineral density measurements
from "aluminum" and "PMMA"
images:
• Aluminum image is
bone-equivalent
density,

Yes, the subject device is
substantially equivalent to the
predicate device as they both used
EOSedge images to compute
clinical parameters.
The subject device is also
equivalent to the reference device
as they both enable bone mineral
assessments to be identified from
bone-equivalent and tissues-
equivalent images.


Manufacturer
EOS imaging
Hologic
EOS imaging

System
VEA Align (K251747)
APEX Software for QDR X-
AutoDensity

• PMMA image is soft
tissue-equivalent
density.

The software allows:
Assessment of patient spinal
global alignment.

The software allows:
• Assessment of bone
density with lumbar
spine, double hip and
wrist examinations.
• Diagnosis of vertebral
fractures using low-
dose spinal imaging.
• Instant quantification of
bone quality of a lumbar
spine examination.
Other functionalities are available
on the system that are not
described in this comparison
table.

The software allows:
Assessment of bone density with
lumbar spine.

Yes, the subject device is
substantially equivalent to the
reference device as they both
assess bone mineral density of
lumbar spine.

VEA Align workflow is divided
into the following steps:
• Data Acquisition
• Data Computation
• Report Generation

APEX software workflow is
divided into the following main
steps:
• Data Acquisition,
• Data Computation,
• Report Generation.

AutoDensity workflow is divided
into the following main steps:
• Data Ingestion,
• Data Computation,
• Report Generation.

X-ray images from EOS and
EOSedge systems

Dual-energy X-ray images from
EOSedge systems

Yes, the subject device is
substantially equivalent to the
predicate device as they both uses
EOSedge images as input.

APEX software processes data
and generates:

AutoDensity processes data and
generates:


• Preview of the spine
used to compute
landmarks and clinical
parameters
• Alignment clinical
parameters

• Previews with vertebrae
used for BMD
computation,
• BMD measurement.

• Previews with vertebrae
used for BMD
computation,
• BMD measurements.

generate clinical parameters and
preview of the images used to
compute them.
The subject device is also
equivalent to the reference device
as they both process data and
generate previews and BMD
measurements.

VEA Align computes landmarks
associated with vertebral centers
and endplates needed to
calculate coronal and sagittal
clinical parameters.

Region of interest detection is
done for at least the following
anatomical body part:
• Spine (lumbar
vertebrae):
Frontal: L1, L2,
o
L3 and L4

Region of interest detection is
done for the following anatomical
body part:
• Spine (lumbar
vertebrae)
o Frontal: L1, L2,
L3 and L4.

Yes, the subject device is
substantially equivalent to the
reference device as they both
perform region of interest detection
on similar anatomical body parts.

Bone Mineral Density values are
computed for at least the
following anatomical body part:
• Spine (lumbar
vertebrae):
o Frontal: L1, L2,
L3, L4 and
total BMD

Bone Mineral Density values are
computed for the following
anatomical body part:
• Spine (lumbar
vertebrae):
o Frontal: L1, L2,
L3, L4 and
total BMD

Yes, the subject device is
substantially equivalent to the
reference device in that Bone
Mineral Density values are also
computed using L1 to L4.

Patient information
Examination information
Landmark detection
Alignment clinical parameters

Patient information
Examination information
ROI detection
Bone Mineral Density Values


Image Acquisition*
Field of View
Full Spine

Disease Conditions
Degenerative – Spine
Normal-Mild

Lumbar Morphometry
(Levels evaluated
separately; maximum
angle compared to
view-plane)

Vertebral Sagittal Angle for
L1, L2, L3 and L4 each, and
maximum

Vertebral Axial Rotation
(VAR) for L1, L2, L3 and L4
each, and maximum


Medical Image Management And
Processing System

PeekMed web is a system designed to
help healthcare professionals carry out
pre-operative planning for several surgical
procedures, based on their imported
patients’ imaging studies. Experience in
usage and a clinical assessment is
necessary for the proper use of the system
in the revision and approval of the output
of the planning. The multi-platform system
works with a database of digital
representations related to surgical
materials supplied by their manufacturers.
This medical device consists of a decision
support tool for qualified healthcare
professionals to quickly and efficiently
perform the pre-operative planning for
several surgical procedures, using medical
imaging with the additional capability of

Table 1: Summary of Predicate and Subject Device Characteristics to Demonstrate Substantial Equivalence


capability of planning the 2D or 3D
environment. The system is designed for
the medical specialties within surgery and
no specific use environment is mandatory,
whereas the typical use environment is a
room with a computer. The patient target
group is adult patients who have an injury
or disability diagnosed previously. There
are no other considerations for the
intended patient population.

No contraindications specific to this
device.

PeekMed web allows the surgeon to
perform orthopedic pre-surgical planning
efficiently in the musculoskeletal system
(e.g., Hip procedures, Knee procedures)

PeekMed web allows the surgeon to
perform the pre-surgical planning
efficiently in the following anatomical
regions:
- Hip
- Knee
- Upper limb
- Foot

Patient Population
Adults
Adults
Yes
---

End users
Healthcare Professionals
Healthcare Professionals
Yes
---


Software is cloud-based (not installable)
and can be displayed on any personal
device or workstation that can run on a
web browser

Distributed system (cloud-based). This
distributed system is a combination of
software modules placed on servers that
are able to communicate with each other.

The workflow is as follows: Import case
images, configure images, identify the
case, pre-surgical planning, and export
the case.

Internet connection
Required
Required
Yes
---

Receives medical images from various
sources

The software processes data to provide
an overlap and dimensioning of digital
representations of the prosthetic material

Allows the overlap of models and the
intersection of the models


Support for digital
prosthetic
materials provided
by the
manufacturers

Human
intervention for
image
interpretation

Ability to add
additional modules
when available

Yes
- Hip (X-ray and CT scan)
- Knee (X-ray and CT scan)

Yes
- Hip (X-ray and CT scan)
- Knee (X-ray, CT scan, and MRI)

The subject device includes a new ML
model variant for segmentation.
Both devices allow planning for the


- Upper limb (CT scan)
- Foot (X-ray and CT scan)

knee region with X-rays and CT scans,
but the subject device also allows with
MRI.
This does not constitute an intended
purpose update, nor does it raise
questions of safety and performance,
since the development, verification,
validation, and deployment processes
are the same for both devices.

Automatic or Manual
- Hip
- Knee
- Upper limb
- Foot


Manufacturer Name:
FUJIFILM SonoSite, Inc.

Common Name:
Diagnostic System and Transd

Regulation Name:
Ultrasonic Pulsed Doppler Ima


PIV Assist
validated on
Sonosite LX and
Sonosite PX
Ultrasound
System
(This
submission)

Sonosite LX
Ultrasound
System
(K233597)
Predicate device

Sonosite PX
Ultrasound
System
(K213763)
Reference device

Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body

Abdominal
Adult Cephalic
Neonatal Cephalic
Cardiac Adult
Cardiac Pediatric
Fetal – OB/GYN
Musculo-skeletal
(Conventional) Musculo-
skeletal (Superficial)
Ophthalmic
Pediatric
Peripheral vessel
Small Organ (breast,
thyroid, testicle,
prostate)
Transrectal
Transvaginal
Trans-esophageal
(cardiac)
Needle Guidance

Linear Array
Curved Linear Array
Phased Array
Intracavitary
Trans-esophageal


Global
Maximum
Outputs/
Worst
Case
Setting

Display Feature for
Higher Outputs MI
Output Display TI Output
Display

Same
Same as predicate and
reference device

B-mode Grayscale
Imaging
Tissue Harmonic Imaging
M-mode
Simultaneous M-Mode
Anatomical M-Mode
Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW)
Doppler
Continuous Wave (CW)
Doppler
Speckle reduction
algorithm (formerly
branded as SonoHD2
Noise Reduction)
SonoMB/MBe Image
Compounding
CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging
(TDI)

DICOM 3.0
Store, Modality Worklist,
Modality Perform
Procedure Step (MPPS),
Storage Commitment,
Structured reports,
offline media


Transducers:
Silicone Rubber
Polysulfone
PolyVinylChloride (PVC)
Silicone RTV Adhesive
Silicone
Polymethyl-pentene
Epoxy Paste Adhesive
Polyurethane
FKM rubber
Thermoplastic
polyurethane
Needle Guides: Acetal
copolymer Acrylonitrile-
butadien- styrene (ABS)

PIV Assist is validated
on both Sonosite PX
and Sonosite LX
Ultrasound Systems.
No hardware changes
were made to either of
these devices to
include PIV Assist.
New features
include -
• L12-3 PIV Assist
feature added to
Peripheral
IntraVenous Exam
Type
• L19-5 PIV Assist
feature added to
Peripheral IntraVenous
and Vascular Access
Exam Types

Sonosite LX:
21.3 “Projected
Capacitive (PCAP) touch
screen interface
Storage bin capacity: 11
lbs. (5 kg)
Stand depth: 25.4 in.
(64.5 cm)
Stand width: 23.0 in.
(58.4 cm)
Height range: max with
monitor up 68 in. (172.7
cm); min with monitor
down 49 in. (124.5 cm)
Weight (system and
accessories including
safe working load):
151.68 lbs. (68.8 kg)
2 USB 2.0 Ports

Sonosite PX:
Beamformer 128/128
15.6” capacitive screen
interface
Storage bin capacity: 11
lbs
Stand depth: 25.4 in
(64.5 cm)
Stand width: 23.0 in.
(58.4)
Height: 45 in. (114.3
cm) maximum, 33 in.
(83.8 cm) minimum
Weight: 17.92 lbs (8.13
kg) with the L15-4
transducer and battery
installed
Total Stand weight with
systems and


Reference Number
Recognition Number
Title

ANSI AAMI IEC
62304:2006/A1:2016
Medical device software -
Software life cycle
processes [Including
Amendment 1 (2016)

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


Classification Description
21 CFR §
Product Code

System, imaging, pulsed doppler,
ultrasonic

System, imaging, pulsed echo,
ultrasonic

Transducer, ultrasonic, diagnostic
892.1570
ITX

Automated Radiological Image
Processing Software

Diagnostic Intravascular Catheter
870.1200
OBJ*

Common Name Diagnostic Ultrasound System and Transducers


Rapid LVO is a radiological
computer aided triage and
notification software indicated for
use in the analysis of CTA head
images. The device is intended to
assist hospital networks and trained
radiologists in workflow triage by
flagging and communication of
suspected positive ICA or MCA-M1
Large Vessel Occlusion (LVO)
findings in head CTA images.
Rapid LVO uses a software
algorithm to analyze images and
highlight cases with suspected LVO
on a server or standalone desktop
application in parallel to the ongoing

Rapid CTA 360 is a radiological
computer aided triage and
notification software indicated for
use in the analysis of CTA adult
head images. The device is intended
to assist hospital networks and
trained clinicians in workflow triage
by flagging and communication of
suspected positive Large and
Medium Vessel Occlusion findings
in head CTA images including the
ICA (C1-C5), MCA (M1-M3),
ACA, PCA, Basilar and Vertebral
vascular segments.
Rapid CTA 360 uses an AI software
algorithm to analyze images and

the Rapid CTA 360 software device that is the subject of this Traditional 510(k) submission.


standard of care image
interpretation. The user is presented
with notifications for cases with
suspected LVO findings.
Notifications include compressed
preview images. These are meant for
informational purposes only and are
not intended for diagnostic use
beyond notification. The device does
not alter the original medical image
and is not intended to be used as a
diagnostic device.
The results of Rapid LVO 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.

highlight cases with suspected
occlusion on a server or standalone
desktop application in parallel to the
ongoing standard of care image
interpretation. The user is presented
with notifications for cases with
suspected LVO and MVO findings.
Notifications include compressed
preview images. These are meant for
informational purposes only and are
not intended for diagnostic use
beyond notification. The device does
not alter the original medical image
and is not intended to be used as a
diagnostic device.
The results of Rapid CTA 360 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.

ICA (C1-C5), MCA (M1-M3),
ACA, PCA, Basilar and Vertebral

iSchemaView - Traditional 510(k) Rapid CTA 360 510(k) Summary


GE Medical Systems Israel, Functional Imaging

Regulation number
21CFR 892.1200 and 21CFR 892.1750


Specification /
Predicate Device:
Proposed Device:

Dual NaI-based detectors NM system
for Planar and SPECT imaging, with
“Real-time Time Activity Curve” option
for Planar Dynamic Scans

Dual NaI-based detectors NM system for
Planar and SPECT imaging, with “Real-
time Time Activity Curve” option for
Planar Dynamic Scans and DL Automatic
Kidney Segmentation

GEHC Commercially Available
Revolution Ascend (K213938)

Dual axis table for Planar, SPECT, CT
and SPECT / CT Imaging
SPECT Scan Range: 200cm
SPECT-CT Scan Range: 185 cm

IEC 60601-1 and applicable Collateral
and Particular Standards.

510(k) Premarket Notification Submission for Aurora


Item
Proposed Device
Predicate Device
Remark


Shanghai United Imaging Healthc
are Co., Ltd.

Live 2D Camera for patient positioning and


Auto tracking for
adjusting the table
height is maintained

Yes, X-ray tube follows table height adjustment;
source-image distance is maintained.

Auto tracking for
longitudinal tube
travel

Yes, detector follows tube movement;
centering maintained.


ANSI/AAMI ES 60601-1:2005 & A1:2012 &
A2:2021 Medical electrical equipment - Part 1:
General requirements for basic safety and
essential performance

EMC
Comply with IEC 60601-1-2:2014+A1:2020
Comply with IEC60601-1-2
Same

Patient Contact Materials were tested and
demonstrated no cytotoxicity (ISO 10993-5),
no evidence for irritation and sensitization (ISO
10993-10).

Clinical Image Evaluation for the proposed device are provided in Section 11.5 Clinical Image Evaluation.

Power Source
AC Line, Various voltages available
AC Line, Various voltages available
Same


Item
Proposed Device
Reference Device
Remark

Users can manually adjust FOV and
stitching range on the workstation.
To assist the users with setting the FOV
and stitching range, exam range is
automatically planned for chest and
stitching range is automatically planned for
WholeSpine & WholeLowerExtremity.

-Virtual Collimation
Manually adjust collimation size on
imaging system by 3D camera
-Smart Virtual Ortho:
Ortho range set by 2D camera in the
image system manually
-Auto Thorax Collimation
Exam range automatically planned for
Thorax by 3D camera with manual
adjustment
-Auto Full-Spine& Long-Leg
Collimation:
Ortho range automatically planned for
Full-Spine &Long-Leg by 2D camera
with manual adjustment

Table2: Comparison of new features to predicate device


The larger the image matrix size, the higher the resolution, and the greater the capability to capture fine
structures, which means the ability to identify smaller lesions and tissues. The difference does not introduce
safety and effectiveness issues.

Effective Radiographic Size refers to the actual area size of the detector panel that can be utilized in practical
imaging. A larger Effective Radiographic Size indicates that the detector can cover a larger range of anatomical
areas in practical use. The difference does not introduce safety and effectiveness issues.

Only the different of size specification, does not affect safety and effectiveness. The 35cm x 43cm normally
used in free exam mode which is different with 41.5cm x 42.6cm which used in the tray in table.

2D camera only introduced to capture optical information and support more clinical operational possibilities.,
does not affect safety and effectiveness.

Detector travel range refers to the movement range of the tray in Table. A larger travel range indicates a larger
coverage on table and more operational possibilities. The difference does not introduce safety and effectiveness
issues.


uAid evaluates the positioning quality of chest images with deep learning methods. It efficiently and objectively
categorizes images into three levels according to four criteria, to assist standardizing the management of image
quality/technologist skills. The difference does not introduce safety and effectiveness issues.

For manually adjust collimation size and automatically planned for chest and stitching range these two functions
are same with predicate device MULTIX Impact C, the difference is the description way, the difference does not
introduce safety and effectiveness issues.


Additional non-clinical tests are conducted for key features to ensure safe and effectiveness when integrated into the system:


Case of Non-
Compliant Cases in
System-
Automatically Set
Results

Full Spine or Full
Lower Limb
Stitching/case

Case of Non-
Compliant Cases in
System-Automatically
Set Results

for chest PA、WholeSpine and WholeLowerExtremity


Total number of 328 14 20 0
cases in a week
Equipment and Protocols
The test data was collected, and the testing protocol included chest, Whole-spine
stitching, Whole-Lower-extremity stitching.
Clinical Subgroups
No clinical subgroups and confounders have been defined for the datasets.
Testing & Training Data Independence
The testing dataset was collected independently from the training dataset, with separated
subjects and during different time periods. Therefore, the testing data is entirely independent
and does not share any overlap with the training data.
Summary
According to the results of the current equipment statistics, in 95% of patient positioning
processes, the light field and equipment position automatically set by uVision can meet the
clinical positioning and shooting requirements. In the remaining 5% of cases, based on the
light field and system position automatically set by the equipment, technicians still need to
make manual adjustments

Introduction
uAid is used for checking the quality of examination and positioning. The results can help to
assist with departmental management functions. uAid is triggered after the acquisition of
chest X-ray images in patients aged over 20 years, which automatically evaluates image
characteristics against four criteria, namely whether there is a foreign object, whether the
lung field is complete, whether the scapula is open, and whether the spine is located on the
center line, categorizing images into one of three quality levels. The outcome of the
evaluation is instantly accessible to radiologic technologists, reminding them to verify that
the image meets the image quality control. It bears emphasis that the result of image quality
control is for reference only and cannot be used as the basis for clinical diagnosis.
Acceptance Criteria
uAid is designed to provide an objective image evaluation method, offering hospitals a
unified assessment tool to manage images/technicians. The accuracy of non-standard image


 Age and gender distribution of data sets for uAid：


In addition, the SW architecture was changed to separate the image communication platform

from the BriefCase-Triage SW. The subject device consists of only the algorithm analysis module which can be

integrated with image communication platforms that meet the BriefCase-Triage input and output

Triage for BA (K213721) are identical in most aspects and differ mostly with respect to their algorithm


Subject Device
Aidoc BriefCase-Triage for BA

Predicate Device
Aidoc BriefCase-Triage for BA (K213721)

BriefCase-Triage is a radiological computer
aided triage and notification software
indicated for use in the analysis of contrast-
enhanced CT images that include the brain,
in adults or transitional adolescents aged 18
and older. The device is intended to assist
hospital networks and appropriately trained
medical specialists in workflow triage by
flagging and communication of suspected
positive cases of Brain Aneurysm (BA)
findings that are 3.0 mm or larger.
BriefCase-Triage uses an artificial intelligence
algorithm to analyze images and flag suspect
cases 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-Triage 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

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.


responsible for viewing full images per the
standard of care.

Hospital networks and appropriately trained
medical specialists

Brain Aneurysm (BA) findings that are 3.0 mm
size or larger

Brain Aneurysm (BA) findings above 5 mm size

Contrast-enhanced CT images that include
the brain

Computed tomography angiography (CTA) of
the head

Notificatio
n-only
(/notificati
on alerts),
parallel
workflow
tool

No. No cases are removed from
desktop app or deprioritized


Inclusion/
Exclusion
criteria for
clinical
performan
ce testing

Inclusion criteria
● Contrast-enhanced CT images that
include the brain
● Scans performed on
adults/transitional adults ≥ 18 years of
age.
● Slice thickness; 0.5 mm – 2.5
mm axial slices.
Exclusion Criteria
● All studies that have an inadequate
field of view.

Inclusion criteria
● computed tomography
angiography (CTA) of the head.
● Scans performed on
adults/transitional adults ≥ 18 years of
age.
● Scans performed on CT
scanners with 64 or greater number of
detectors.
● Slice thickness; 0.5 – 2.5 mm
axial slices.
Exclusion Criteria
● All scans that are technically
inadequate, including motion artifacts,
severe metal artifacts, or an inadequate
field of view.

Artificial intelligence algorithm with
database of images.

- Integrated with image routing module via
image communication platform (ICP) (image
acquisition).
- Algorithm module (image processing)
- Integrated with desktop application for
workflow integration (feed and non-
diagnostic Image Viewer).

- AHS module ( image acquisition);
- ACS module (image processing);
- Aidoc Desktop Application for workflow
integration (Feed/Worklist (alternate
names) and non-diagnostic Image
Viewer).


Time -to-notification
Mean
N
95% Lower
95% Upper
Median

Table 2. Time-to- notification comparison for BriefCase-Triage devices (Seconds)


Table 4. Frequency Distribution of Gender *


Table 6. Frequency Distribution of slice thickness


Table 7. Frequency Distribution of protocol


Subject Swoop Portable MR Imaging
Predicate Swoop Portable MR Imaging

The Swoop Portable MR Imaging System
is a portable, ultra-low field magnetic
resonance imaging device for producing
images that display the internal
structure of the head where full
diagnostic examination is not clinically
practical. When interpreted by a trained
physician, these images provide
information that can be useful in
determining a diagnosis.

Adult and pediatric patients (≥ 0 years)

At the point of care in professional
health care facilities such as emergency
rooms, intensive/critical care units,
hospitals, outpatient, or rehabilitation
centers.

Energy Used and/or delivered:
Magnetic Resonance
Same

Physical Dimensions
835 mm x 630 mm x 652 mm
Same

Field Strength
63.3 mT permanent magnet
Same

Strength
X: 24 mT/m, Y: 23 mT/m, Z: 39 mT/m
Same

Rise Time
X: 2.1 ms, Y: 2.0 ms, Z: 3.8 ms
Same

The table below compares the subject device to the predicate.


Slew Rate
X: 24 T/m/s, Y: 22 T/m/s, Z: 21 T/m/s
Same

Computer Display
Hyperfine-supplied tablet
Same

Inner Dimensions (mm)
205 mm x 240 mm
Same

Patient Weight Capacity
1.6kg-200 kg
Same

Noise correction and line noise
suppression for all sequences

T1W
• T1-Standard
• T1-Gray/White Contrast

Advanced Gridding,
Fast Iterative Shrinkage Thresholding
Algorithm (FISTA)

• Advanced Denoising
• Image orientation transform
• Geometric distortion correction
• Receive coil intensity correction
• Advanced Interpolation
• DICOM output

• Advanced Denoising
• Image orientation transform
• Geometric distortion correction
• Receive coil intensity correction
• DICOM output


Test
Test Description
Applicable Standard(s)

Software verification testing in accordance with
the design requirements to ensure that the
software requirements were met.

• IEC 62304:2016
• FDA Guidance, “Content of Premarket
Submissions for Device Software
Functions”

Testing to verify the subject device meets all
image quality criteria.

• NEMA MS 1-2008 (R2020)
• NEMA MS 3-2008 (R2020)
• NEMA MS 9-2008 (R2020)
• NEMA MS 12-2016
• American College of Radiology
standards for named sequences

Testing to verify cybersecurity controls and
management.

• FDA Guidance, “Cybersecurity in
Medical Devices: Quality System
Considerations and Content of
Premarket Submissions”

Validation to ensure the subject device meets
user needs and performs as intended.

requirements and applicable standards to support substantial equivalence.


Biocompatibility testing of patient-contacting
materials.

Cleaning and disinfection validation of patient-
contacting materials.

• FDA Guidance, “Reprocessing Medical
Devices in Health Care Settings:
Validation Methods and Labeling”
• ISO 17664:2017
• ASTM F3208-17

Electrical Safety, EMC, and Essential Performance
testing.

Characterization of the Specific Absorption Rate
for Magnetic Resonance Imaging Systems.

modifications did not introduce a new worst-case configuration or scenario for testing.


Gender
Female Male Unknown
55% 30% 15%
Age
0-2 2-18 18-35 35-60 60+ 18+* Unknown
16% 14% 11% 20% 23% 9% 7%
*partially anonymized
Ethnicity data not recorded.
Number of sites: 9
Equipment
Swoop Mk1.7 Swoop Mk1.8 Swoop Mk1.9
57% 9% 34%
Included pathology: Alzheimer’s Disease, Hemorrhage, Hydrocephalus,
Hypoglycemia, Intracereberal Hemorrhage, Multiple Sclerosis, Subdural
Hemorrhage, Seizure, Traumatic Brain Injury, Treacher Collins Syndrome,
Tumor, White Matter Hyperintensity

Gender:
Female Male Unknown
41% 47% 12%
Age:
0-2 2-18 18-35 35-60 60+ Unknown
21% 15% 18% 23% 18% 5%
Ethnicity data not recorded.
Number of sites: 6
Equipment:
Swoop Mk1.7 Swoop Mk1.9
73% 27%
Included pathology: Alzheimer’s Disease, Hemorrhage, Hydrocephalus,
Hypoglycemia, Subdural Hemorrhage, Seizure, Traumatic Brain Injury,
Thrombosis, Treacher Collins Syndrome, White Matter Hyperintensity


Gender:
Female Male Unknown
62% 17% 21%
Age:
0-2 2-18 18-35 35-60 60+ 2+* Unknown
8% 31% 7% 10% 31% 9% 4%
*partially anonymized
Ethnicity data not recorded.
Number of sites: 8
Equipment type:
Swoop Mk1.7 Swoop Mk1.8 Swoop Mk1.9
36% 18% 46%
Included pathology: stroke, white matter disease, hemorrhage, tumor, hydrocephalus,
cerebral edema, hypoxic brain injury, Alzheimer’s, Treacher-Collins syndrome, seizures,
multiple sclerosis, post-surgical tumor resection, and thrombectomy follow-up


Gender:
Female Male Unknown
31% 23% 46%
Age:
0-2 2-18 18-35 35-60 60+ 2+*
6% 11% 6% 17% 39% 21%
*partially anonymized
Ethnicity data not recorded.
Number of sites: 11
Equipment type:
Swoop Mk1.7 Swoop Mk1.8 Swoop Mk1.9
20% 10% 70%
Included pathology: Alzheimer’s Disease, Cavernous malformation, Cerebral Amyloid
Angiopathy, Cerebral Tuberculosis, Cortical dysplasia, Edema, Empyema Evacuation,
Ethmoidectomy, Hemorrhage, Hydrocephalus, Multiple Sclerosis, Subarachnoid
Hemorrhage, Subdural Hemorrhage, Seizure, Stroke, Subdural Empyema, Thrombosis,
Treacher Collins Syndrome, Tumor, White Matter Hyperintensity

each sequence-available image orientation (axial, sagittal, coronal) were used.


510(k) Sponsor
Ever Fortune.AI Co., Ltd.

Address
8F., No.360, Sec. 1, Jingmao R
d.,

Classification Name
Radiological Image Processing
Software
For
Radiation
Therapy

Proprietary Name
EFAI RTSUITE CT HCAP-Seg
mentation
Sy
stem


Radiological Image Processing Software For Radiation Therapy


EFAI RTSUITE CT HCAP-Segmentation System


Device Name
Seg Pro V3
EFAI HCAPSeg
AutoContour RADAC V4

Seg Pro V3 is a software
device intended to assist
trained radiation oncology
professionals, including, but
not limited to, radiation
oncologists, medical
physicists, and dosimetrists,
during their clinical
workflows of radiation
therapy treatment planning
by providing initial contours
of organs at risk on DICOM

EFAI HCAPSeg is a
software device intended to
assist trained radiation
oncology professionals,
including, but not limited to,
radiation oncologists,
medical physicists, and
dosimetrists, during their
clinical workflows of
radiation therapy treatment
planning by providing initial
contours of organs at risk on

AutoContour is intended to
assist radiation treatment
planners in contouring and
reviewing structures within
medical images in
preparation for radiation
therapy treatment planning.

The proposed and predicate
devices share the same
intended use: assisting
trained radiation oncology
professionals in generating
initial contours of organs at
risk (OARs) for radiation
therapy planning. While the
proposed device supports
both CT and MR images and
the predicate device supports
only CT, this difference in


images. Seg Pro V3 is
intended to be used on adult
patients only.
The contours are generated
by deep-learning algorithms
and then transferred to
radiation therapy treatment
planning systems. Seg Pro
V3 must be used in
conjunction with a
DICOM-compliant treatment
planning system to review
and edit results generated.
Seg Pro V3 is not intended to
be used for decision making
or to detect lesions.
Seg Pro V3 is an adjunct tool
and is not intended to replace
a clinician's judgment and
manual contouring of the
normal organs on DICOM
images. Clinicians must not
use the software generated
output alone without review
as the primary interpretation.

non-contrast CT images.
EFAI HCAPSeg is intended
to be used on adult patients
only.
The contours are generated
by deep-learning algorithms
and then transferred to
radiation therapy treatment
planning systems. EFAI
HCAPSeg must be used in
conjunction with a
DICOM-compliant treatment
planning system to review
and edit results generated.
EFAI HCAPSeg is not
intended to be used for
decision making or to detect
lesions.
EFAI HCAPSeg is an
adjunct tool and is not
intended to replace a
clinician's judgment and
manual contouring of the
normal organs on CT.
Clinicians must not use the
software generated output
alone without review as the
primary interpretation.

imaging modality does not
alter the intended use or raise
new questions of safety or
effectiveness. The reference
device is not included in this
comparison, as it is not used
to establish substantial
equivalence in intended use.

Windows based .NET
front-end application that
also serves as agent
Uploader supporting

The proposed and predicate
devices are Linux-based


Microsoft Windows 10
(64-bit) and Microsoft
Windows Server 2016.
Cloud-based Server based
automatic contouring
application compatible with
Linux.
Windows python-based
automatic contouring
application supporting
Microsoft Windows 10
(64-bit) and Microsoft
Windows Server 2016.

Trained medical
professionals including, but
not limited to, radiation
oncologists, medical
physicists, and dosimetrists.

All devices are intended for
use by trained radiation
therapy professionals. User
groups are functionally
equivalent.

CT or MR input for
contouring or
registration/fusion. PET/CT
input for registration/fusion
only. DICOM RTSTRUCT
for output

The proposed device
supports both CT and MR
images, while the predicate
device supports only CT. The
reference device also
supports CT and MR for
contouring and fusion. The
proposed device aligns with
the performance of
commercially available
products on the market,
specifically Reference
Devices.

CT models include 166
organs-at-risk (OARs) across

CT models include 80 OARs
across the head-and-neck,

CT or MR input for
contouring of anatomical

Both the proposed and
predicate devices cover the


criteria) for each OAR, are shown in the following tables.


D, standard deviation. CI
, confidence in
terval.


SD, standard deviation. CI, confidence interval.


Model weight updates via retraining on representative real-world
datasets intended to correct performance degradation at local or global
scales.

Predefined verification and validation using prospectively collected
real-world data and the Golden dataset, including quantitative
performance metrics (e.g., DSC), subgroup analyses, and
post-deployment clinical monitoring with predefined acceptance criteria
and rollback controls.

Re-trained models are deployed via controlled global and constrained
local strategies, guided by predefined triggers, verification and
validation criteria. This process is supported by rigorous data
management, including the regulated expansion and retirement of
real-world and Golden test datasets, ensuring continued safety,
effectiveness, and substantial equivalence.
Controlled user notification via established communication procedures,
including advance release notices, version documentation updates, and
standardized rollback notifications, in accordance with the PCCP.

controls defined in this PCCP is provided in the table below:


DeviceName AccuContour AccuContour-Lite AccuContour

It is used by radiation oncology department to
segmentCTimages,to generate needed information
for treatment planning, treatment evaluation and


imagesandsegment
(non-contrast)CTimages,
togenerateneeded
informationfortreatment
planning,treatment
evaluationandtreatment
adaptation.

Non-ContrastCT
DICOM3.0compliance
required.（OriginalCT
andSyntheticCT）

Algorithm IntensityBasedwith No IntensityBasedwithGPU


Autorigidregistration:
CT,MRI,PET,4DCT
Autodeformable
registration:CT,MRI,
CBCT,4DCT

Autorigidregistration:
CT,MRI,PET
Autodeformable
registration:CT,MRI,
CBCT


Structure Pass DSC DSC LowerBound HD95 HD95 LowerBound


Table1:Te st Resu ltsforsynt h eticCT generate dfromMR images

Structure
Pass
DSC
DSC Low
erBound
HD95
HD95
Low
erBound

Cr iteria Mean STD 95%CI Mean STD 9 5%CI


SpectraWAVE
12 Oak Park Drive
Bedford, MA 01730, USA

Pie Medical Imaging BV
Philipsweg 1, 6227 AJ
Maastricht, The Netherlands

The SpectraWAVE X1-FFR
Software is a software
product intended to be used
by or under the supervision of
a cardiologist in order to aid in
reading, co-registering, and
interpreting cardiovascular X-
ray images to support in
diagnoses and for assistance
during the intervention of
cardiovascular conditions.

CAAS Workstation is a
modular software product
intended to be used by or
under supervision of a
cardiologist or radiologist in
order to aid in reading, co-
registering and interpreting
cardiovascular X-Ray images
to support diagnoses and for
assistance during intervention
of cardiovascular conditions.

The SpectraWAVE X1-FFR
Software features
segmentation of coronary
vessels, and measurement
and reporting tools to facilitate
the following use:
• Calculate the dimensions
of coronary vessels;
• Quantify stenosis in
coronary vessels;
• Quantify pressure drop in
coronary vessels;
The SpectraWAVE X1-FFR
Software is intended to be
used by or under the
supervision of a cardiologist.

CAAS Workstation features
segmentation of
cardiovascular structures, 3D
reconstruction of vessel
segments and catheter path
based on multiple
angiographic images,
measurement and reporting
tools to facilitate the following
use:
• Calculate the dimensions
of cardiovascular
structures;
• Quantify stenosis in
coronary and peripheral
vessels;
• Quantify the motion of the
left and right ventricular
wall;
• Perform density
measurements;
• Determine C-arm position
for optimal imaging of
cardiovascular structures;
• Enhance stent
visualization and measure
stent dimensions;

The subject
device indications
are identical to a
subset of the
indications
cleared for the
predicate device.
Indications for the
subject device
focus on the
assessment of
coronary vessels.


• Quantify pressure drop in
coronary vessels;
• Co-registration of
angiographic X-Ray
images with IVUS and
OCT images.
CAAS Workstation is
intended to be used by or
under supervision of a
cardiologist or radiologist.

X-ray angiography in Display
format (vendor independent)

X-ray angiography in DICOM
format (vendor independent);
• IVUS and OCT data in
DICOM format (vendor
independent);
• IVUS data as video
stream

The subject
device data input
type is similar to a
subset of the data
inputs cleared for
the predicate
device.
The subject
device uses X-
Ray angiography
in display format
and does not
accept other
image types.

• 2D X-ray image;
• 3D reconstruction based
on 2 Xray images;
• 2D intravascular image;
• Longitudinal intravascular
reconstruction

The subject
device’s image
display outputs
are identical to a
subset of the
image display
outputs cleared
for the predicate
device.


The subject
device displays
2D X-Ray Images
and does not
display 3D
reconstruction or
intravascular
formats.

• Automatic calibration;
• Vessel dimensions
(diameters, lengths);
• Automatic and manual
stenosis assessment;
• Pressure drop calculation
in coronary vessel

• Manual and automatic
calibration;
• Basic length, diameter,
density and angle
measurements;
• Vessels and ventricle
dimensions (diameters,
areas, volumes);
• Automatic and manual
stenosis assessment;
• Left and right ventricular
wall motion;
• Left ventricular
myocardium dimensions;
• Enhanced stent
visualization;
• Stent dimensions;
• Pressure drop calculation
in coronary vessels;
• Providing common frame
of reference for IVUS and
OCT data with X-ray
angiographic data

The subject
device’s image
assessment
capabilities are
identical to a
subset of the
image
assessment
capabilities
cleared for the
predicate device.
The subject
device’s image
assessment
focuses on the
analysis of
coronary vessels.


Diagnoly
2 Place de Francfort
69003 Lyon, France
+33(0)4.78.76.85.75

Ivan Voznyuk
Chief Executive Officer
Diagnoly
Phone: +33(0)6.95.87.04.55
Email: qara@diagnoly.com

Nima Akhlaghi
Associate Director, Digital Health Regulatory Affairs
MCRA, LLC
Phone: 202.742.3889
Email: nakhlaghi@mcra.com


Accessory to Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550
Accessory to Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560
Medical image management and processing system, 21 CFR 892.2050


Heart views
Quality criteria within the views

Septum primum (Vieussens valve or Fo-ramen Ovale Flap)

Connection between crux and atrial septum (vestibular septum)

(B14) Cr
Atrioventricular valve offset in crux

Connection between interventricular septum and crux

Ultrasound in Obstetrics and Gynecology for the foetal heart screening of 2nd and 3rd trimesters of pregnancy.


Septum between pulmonary artery trunk and ascending aorta

Side space on the left of ductus / pulmonary artery

Ductal arch connected to the descending aorta

Ductal arch not connected to the descending aorta


Brain views
Quality criteria within the views

Ultrasound in Obstetrics and Gynecology for the foetal brain screening of 2nd and 3rd trimesters of pregnancy.


Transcerebellar view
(G7) CB
Cerebellar Border

(I5) rgCC
Rostrum & Genu Corpus Callosum

Sagittal/profile view
(I7) sCC
Splenium Corpus Callosum

(n = 8)
(I8) CSP
Cavum Septum Pellicidum


Reference device:
Voluson Expert
18/20/22 (FETAL HS
Feature)
K220358

Comparison between
Proposed and
Predicate device

Substantially
equivalent
Primary codes are
the same for subject
and primary
predicate devices

- Accessory to Ultrasonic
Pulsed Doppler Imaging
System, 21 CFR 892.1550
- Accessory to Ultrasonic
Pulsed Echo Imaging
System, 21 CFR 892.1560
- Medical image
management and
processing system, 21
CFR 892.2050

- Ultrasonic Pulsed
Doppler Imaging
System, 21 CFR
892.1550
- Ultrasonic Pulsed
Echo Imaging
System, 21 CFR
892.1560
- Diagnostic
Ultrasound
Transducer, 21 CFR
892.1570, 90-ITX

Substantially
equivalent
All devices are class II
devices subject to
510(k) regulatory
pathway.

FETOLY-HEART is a
software that aims at
helping sonographers,
OB/GYNs, MFMs and
Fetal surgeons (all three
designated as healthcare
professionals i.e. HCPs)
to perform their routine
fetal heart ultrasound
examinations in real-
time.

The reference device
is a software that
aims at helping
sonographers,
OB/GYNs, MFMs and
Fetal surgeons (all
three designated as
healthcare
professionals i.e.
HCP) to perform
their routine fetal
heart ultrasound
examinations in real-
time.

FETOLY is a software that
aims at helping sonographers,
OB/GYNs, MFMs and Fetal
surgeons (all three
designated as healthcare
professionals i.e. HCPs) to
perform their routine fetal
heart ultrasound
examinations in real-time.

Substantially
equivalent
The subject device
and the predicate
devices have the
same objective.


Pregnant women during
the 2nd and 3rd
trimester of pregnancy

Substantially
equivalent
Subject device has
the same intended
patient population
than the predicate
devices.

- Images labeled with
correct fetal heart view
for patient cases
- Quality criteria
identified as “Verified”
when detected and “Not
verified” when not
detected
- Images labeled with the
localization of quality
criteria

- Images labeled with correct
fetal heart/brain view for
patient cases
- Quality criteria identified as
“Verified” when detected and
“Not verified” when not
detected
- Images labeled with the
localization of quality criteria
- Images labeled with
measurements and in- and
out- of-range display

Substantially
equivalent
The clinical outcome
is the same between
predicates and
subject devices.
However,
performance testing
has shown that there
is no impact on safety
and effectiveness of
the inclusion in
FETOLY of additional


Qualified healthcare
professional specialized
in prenatal ultrasound
imaging

Substantially
equivalent
Subject device has
the same intended
users as the
predicate devices.

Substantially
equivalent
Clinical application is
the same for subject
and predicate
devices.

Yes, proposed
modifications related to
modifying model training
hyperparameters,
additional retraining with
new training and
validation datasets
collected, and
addition/removal of
heart quality criteria.

Yes, proposed modifications
related to modifying model
training hyperparameters,
additional retraining with
new training and validation
datasets collected,
addition/removal of heart
quality criteria, addition of
fetal heart and brain
biometric measurements

Substantially
equivalent
Subject and predicate
devices both have a
PCCP to update AI
model

Detection of 4ch, 3vx,
LVOT, RVOT and Abd
views (complete
implementation of
ISUOG
recommendations)

Detection of 4ch, 3vx, LVOT,
RVOT and Abd heart views
Detection of TV, TT, TC and
SAG brain views
(complete implementation of
ISUOG recommendations)

Substantially
equivalent
The subject device
includes the
detection of new
views when
compared to the
predicate device. This
quantitative
enhancement has
been tested and does
not raise any new
question of safety
and effectiveness.


Functionality 2: completeness illustration

Automatic extraction of
views from a sequence of
images.

Substantially
equivalent
This image selection
functionality is the
same than for the
predicate device
Software testing has
been performed to
validate its use and
does not introduce
new questions of
safety and
effectiveness.

Heart and brain biometric
measurements, including
angles and ratios

Substantially
equivalent
Performance testing
has shown that there
is no impact on safety
and effectiveness of
the inclusion in
FETOLY of additional
types of
measurements in
comparison with the
reference device.

Functionality 4: Measurement illustration


Accepts images and
image sequences from
ultrasound machines

Substantially
equivalent
The input data is the
same for the subject
device and the
predicate and
reference devices.

Artificial Intelligence:
Utilizes computer vision
algorithms to analyze
ultrasound images and
provides visualization of
detected landmarks and
views

Artificial Intelligence:
Utilizes computer
vision algorithms to
analyze ultrasound
images and provides
measurements

Substantially
equivalent
All devices use
artificial intelligence.

Operates as a local
software functioning
independently from the
ultrasound equipment.

Operates as a local
software embedded
in the ultrasound
equipment.

Substantially
equivalent
Subject and primary
predicate devices use
an edge-based
approach

Compatible with
ultrasound system from
GE Medical, Samsung
and Canon

Substantially
equivalent
This compatibility has
been tested and
validated as part of
device
generalizability in the
performance testing
study.

The user can interact
with the software to
override the software’s
outputs. The user has the
ability to review and
edit/override the
matching at any time
during or at the end of
the exam.

The user has the
ability to review the
software output.

Substantially
equivalent
User interactions are
the same between
primary predicate
and subject devices.


Modification
Rationale
Testing Methods
Impact Assessment

Modification of
training and/or
validation datasets

Increase or recovery (in
case of data drift) of
FETOLY’s performance.

Re-training of the FETOLY
model with new data to
optimize its performance
followed by internal testing
and a comparison of the initial
model to the modified model
using performance metrics on
the test dataset.

Increased performance metrics of the
modified model for view or quality criteria
or subview detection.
Increased performance metrics of the
modified model for realization of
quantitative biometric measurements.

Summary of changes to FETOLY per the PCCP:


Modification of
model training
hyperparameters

Improvement/
optimization,
maintenance or recovery
(in case of data drift) of
FETOLY’s performance
Maintain alignment with
quality criteria and
biometric measurements
recommended for fetal
heart and brain screening
in state-of-the-art
international guidelines.

Re-training of the FETOLY
model with new parameters
to optimize its performance
followed by internal testing
and a comparison of the initial
model to the modified model
using performance metrics on
the test dataset.

Increased performance metrics of the
modified model for view or quality criteria
or subview detection.
Increased performance metrics of the
modified model for realization of
quantitative biometric measurements.
Enhanced compliance with standard
international guidelines.
Benefits: Increased , maintained or
recovered performance; generalization for
diverse cases; keeping the device relevant
by aligning with the updated list of heart
and brain quality criteria/measurements
Risks: Performance decrease (overfitting,
unintended bias).
Risk mitigation: The modified model will
be tested for superiority on the
performance study test dataset which will
contain new unseen data.

Heart or brain quality
criteria
addition/removal

Maintain alignment with
quality criteria
recommended for fetal
heart and brain screening
in state-of-the-art
international guidelines.

New quality criteria list will be
controlled using the same
acceptance criteria as defined
by secondary endpoints.

Enhanced compliance with standard
international guidelines.
Benefits: Keeping the device relevant by
aligning with the updated list of heart and
brain quality criteria.
Risks: Performance decrease and user
confusion.
Risk mitigation: Proper performance
testing with no decrease in test
performance. This change only pertains to
quality criteria belonging to one of the 5
heart views or 4 brain views already
included in FETOLY.


Scanner manufacturer
Samsung
342 (45.6%)
2267 (40.1%)

Image digital quality
Average
1446 (26%)

The subgroups distribution is summarized in the table below:


Asian and Pacific Islander
30 (4%)
196 (3.5%)

Race and ethnicity
Hispanic
57 (7.6%)
411 (7.4%)


- Realization of fetal heart and brain biometric measurements:


model’s robustness and generalizability. The subgroups distribution is summarized in the table below:


Scanner manufacturer
Samsung
156 (35.4%)
1925 (32%)

Pregnancy type
No high-risk
279 (63.3%)
3835 (63.7%)

Image digital quality
Average
2847 (47.3%)

Asian and Pacific Islander
20 (4.5%)
251 (4.2%)

Race and ethnicity
Hispanic
33 (7.5%)
445 (7.4%)


Device Name,
Cartesion Prime
Cartesion Prime

Deviceless PET
Respiratory gating
system

Pediatric Imaging: Available
Intensity Settings:
Smooth, Standard, Sharp

Pediatric Imaging: Not Available
Intensity Settings:
ON/OFF


Super-conducting magnet, horizontal bore,
1.5 Tesla

Bore dimension
Circle shape with diameter 70cm
Circle shape with diameter 70cm

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

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

Internal Type Name: EM-7
Internal Type Name: EM-7 or EM-7A

Fixed table
Fixed table or Dockable table


☐ Manufacturing Process
☐ Labeling
☐ Technology

These devices have changed but there are no significant changes in technology, engineering and performance.


ECHELON Synergy MRI System (K241429)
ECHELON Synergy

Receiver Coils
FlexFit Neuro Coil
FlexFit Neuro Coil

FlexFit Blanket Coil A,
FlexFit Blanket Coil B

Breast Coil
Breast Support Kit 2
Breast Coil 17
Breast Support Holder

Flex M Coil, Flex S Coil
Flex M Coil, Flex S Coil


Application Software
Going from V10.0A from V11.0A
See Table 7

Following positioning applications are added.

- AutoPose Abdomen, AutoPose Pelvis for male, AutoPose Pelvis for female, AutoPose Cardiac

Following positioning applications are modified.

- AutoPose Knee, AutoPose Shoulder, AutoPose HipJoint

3D Processing Tasks
3D Processing Tasks
Following function is modified.
See Table 7
See Table 7

Network Tools
Network Tools
Following function is modified.
See Table 7
See Table 7

Following Protocol Enhancements are modified.

- Gating: cardiac, peripheral pulse (with multi-gate delay parameter and SSFP capability),

- Echo Planar, Diffusion Weighted Imaging

Following Protocol Enhancements are enhanced.

Following changes are added in Pulse Sequences.

- 2D GE, 2D RSSG, 3D RSSG, 2D GE EPI, 2D DW EPI, 2D Soft GE

Monitoring Tools
Following function is modified.


☐ Manufacturing Process
☐ Labeling
☐ Technology


Shoulder
Knee
HipJoint
Abdomen
Pelvis for
Pelvis for
Cardiac

FUJIFILM Corp.,
FUJIFILM Healthcare
Americas Corp., clinical
sites

Subject Type
Healthy volunteer and patients

The information on the data in the single evaluations is shown below.


Recognition
Standard Number and Date
Standard Name

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

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

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

demonstrates compliance with following international and FDA-recognized consensus standards:


disturbances - Requirements and tests [Including
Amendment 1 (2021)]

IEC 60601-1-6 Edition 3.2 2020-
07 CONSOLIDATED VERSION

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

Medical Electrical Equipment - Part 1-8: General
requirements for basic safety and essential
performance - Collateral Standard: General
requirements tests and guidance for alarm systems
in medical electrical equipment and medical
electrical systems [Including Amendment 2 (2021)]

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

ANSI AAMI IEC 62366-
1:2015+AMD1:2020
(Consolidated Text)

Medical devices Part 1: Application of usability
engineering to medical devices including
Amendment 1

Medical devices – Application of risk management to
medical devices.


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

Xinyu Song
Lead Specialist, Regulatory Affairs, MR
GE HealthCare
Phone: 86 186 1188 4503
E-mail: Xinyu.Song@gehealthcare.com

Glen Sabin
Director - Regulatory Affairs, MR Strategy
GE HealthCare
Phone: 262 894-4968
E-mail: Glen.Sabin@gehealthcare.com

Magnetic Resonance Diagnostic Device per 21 CFR 892.1000

(1) SIGNATM Artist (K202238)
(2) SIGNATM Champion (K233728)

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


3.0T Superconducting
Magnet with active
shielding.

1.5T Superconducting
Magnet with active
shielding.

The magnet has same technology with
different magnet field strength, and
minor modification on enclosure.
It is identical with Reference Device
SIGNATM Artist.

A gradient coil with water-cooled, active-shielded
design.

The gradient coil is modified to
reduced DC resistance and AC
impedance for less cooling
requirements.

3.0T Transmit with
embedded body coil
and local T/R coil.

1.5T Transmit with
embedded body coil
and local T/R coil.

The platform body coil is modified to
reduce thermal and enhance intra-bore
visibility.
The RF Transmit Subsystem except
body coil is identical with Reference
Device SIGNATM Artist.

3.0T Digitize-Per-Pin
(DPP) receive chain
architecture.

1.5T Digitize-Per-Pin
(DPP) receive chain
architecture.

The RF Receive Subsystem uses the
same technology with different RF
frequency.
It is identical with Reference Device
SIGNATM Artist.

predicate/reference devices, as summarized below:


Comprehensive suite
of 3.0T detachable
coils for imaging all
anatomies.

Comprehensive suite
of 1.5T detachable
coils for imaging all
anatomies.

The RF coils use same technology with
different RF frequency.
They are substantial equivalent with
Reference Device SIGNATM Artist’s RF
coils.

The 1.5T AIR Posterior Array coil has
the same fundamental scientific
principles and similar SNR and
Uniformity measurements within their
operated field strength. It is
substantially equivalent with SIGNA™
Premier’s AIR PA coil.

Comprehensive suite of software features, pulse
sequences, and image processing applications to
support MR imaging of all anatomies.

SIGNA™ Sprint uses equivalent
software with predicate and reference
devices.

Respiratory peripheral and cardiac gating with
wireless connection.

SIGNA™ Sprint uses the identical gating
accessories with predicate and
reference devices.


Subject Device
Aidoc Briefcase-Triage for AD

Predicate Device
Aidoc Briefcase-Triage for AD
(K222329)

BriefCase-Triage is a radiological
computer aided triage and notification
software indicated for use in the analysis
of CT chest, abdomen, or chest/abdomen
with contrast (CTA and CT with contrast)
in adults or transitional adolescents aged
18 and older. The device is intended to
assist hospital networks and appropriately
trained medical specialists in workflow
triage by flagging and communication of
suspected positive findings of Aortic
Dissection (AD) pathology.
BriefCase-Triage uses an artificial
intelligence algorithm to analyze images
and highlight cases with detected findings
on a standalone desktop application in
parallel to the ongoing standard of care
image interpretation. The user is
presented with notifications for cases with
suspected findings. Notifications
include compressed preview images that
are meant for informational purposes only
and not intended for diagnostic use
beyond notification. The device does not
alter the original medical image and is not
intended to be used as a diagnostic
device.
The results of BriefCase-Triage are
intended to be used in conjunction with
other patient information and based on
their professional judgment, to assist with
triage/ prioritization.

BriefCase is a radiological computer
aided triage and notification software
indicated for use in the analysis of CT
exams with contrast (CTA and CT with
contrast) that include the chest in adults
or transitional adolescents aged 18 and
older. The device is intended to
assist hospital networks and
appropriately trained medical
specialists in workflow triage by flagging
and communication of suspected
positive findings of Aortic Dissection
(AD) pathology.
BriefCase uses an artificial intelligence
algorithm to analyze images and
highlight cases with detected findings
on a standalone desktop application in
parallel to the ongoing standard of care
image interpretation. The user is
presented with notifications for cases
with suspected findings. Notifications
include compressed preview images
that are meant for informational
purposes only and not intended for
diagnostic use beyond notification. The
device does not alter the original
medical image and is not intended to be
used as a diagnostic device.
The results of BriefCase are intended to
be used in conjunction with other
patient information and based on their
professional judgment, to assist with
triage/ prioritization.


Hospital networks and appropriately
trained medical specialists

CT chest, abdomen, or chest/abdomen
exams with contrast (CTA and CT with
contrast)

CT exams with contrast (CTA and CT
with contrast) that include the chest

Notificatio
n-only
(/notificati
on alerts),
parallel
workflow
tool

No. No cases are removed from
desktop app or deprioritized


Inclusion/
Exclusion
criteria for
clinical
performa
nce
testing

Inclusion Criteria
● Scans performed on
adults/transitional adolescents ≥
18 years of age.
● CT chest, abdomen, or
chest/abdomen exams with
contrast (CTA and CT with
contrast)
● Slice thickness 0.5 mm - 5.0 mm
Exclusion Criteria
● All studies that have an
inadequate field of view

Inclusion Criteria
● Scans performed on
adults/transitional adolescents ≥
18 years of age.
● CT exams with contrast (CTA
and CT with contrast) that
include the chest
● Slice thickness 0.5 mm - 5.0
mm
Exclusion Criteria
● All studies that are technically
inadequate, such as severe
metal artifacts, or inadequate
field of view.

Artificial intelligence algorithm with
database of images.

- Integrated with image routing module via
image communication platform (ICP)
(image acquisition).
- Algorithm module (image processing)
- Integrated with desktop application for
workflow integration (feed and
non-diagnostic Image Viewer).

- AHS module ( image acquisition);
- ACS module (image processing);
- Aidoc Desktop Application for
workflow integration (Feed/Worklist
(alternate names) and
non-diagnostic Image Viewer).


adults/transitional adolescents ≥ adults/transitional adolescents ≥


Briefcase-Triage +
Image
Communication
Platform
Time-To-Notification


Table 4. Frequency Distribution of Gender


Table 5. Frequency Distribution of Manufacturer


Operating Points
Sensitivity % (95% CI)
Specificity % (95% CI)


Legal
Naitive Technologies Limited
16-Bit Inc

Lumbar spine
Thoracic spine
Chest
Pelvis
Knee
Hand/wrist

Both predicate and
subject device are
indicated for
quantification of X-ray
images of the pelvis.

OsteoSight™ is a software application
intended for use opportunistically with standard
anteroposterior (AP) radiographs of the hip or
pelvis performed in patients aged 50 years and
older.. OsteoSight™ provides a notification in

Rho is a software application intended for
use opportunistically with standard frontal
radiographs of the lumbar spine, thoracic
spine, chest, pelvis, knee, or hand/wrist
performed in patients aged 50 years and

Table 1. Comparison of Technological Characteristics & Intended Use to Predicate Device


the form of a report to aid radiologists and/or
physician interpreters in identifying patients
with possible low bone mineral density (BMD)
at the femoral neck to prompt a clinical
assessment of bone health. OsteoSight™
should not be used to rule out low BMD.
Radiologists and referring clinicians should
follow recommended practices for screening
and assessment, regardless of the absence of
an OsteoSight™ report.

older. Rho provides a notification in the form
of a report to aid radiologists and/or
physician interpreters in identifying patients
with possible low bone mineral density
(BMD) at L1-L4 or the femoral neck to
prompt a clinical assessment of bone
health. Rho should not be used to rule out
low BMD. Radiologists and referring
clinicians should follow recommended
practices for screening and assessment,
regardless of the absence of Rho report.

Adults ≥ 50 years who undergo an X-ray as
part of their standard of care

When reporting the X-ray, the radiologist or
physician interpreter can review the OsteoSight

Rho can be installed on-premise or in the
cloud, however, it must be within your


Report, and, if in agreement, can simply include
this finding in their own words. OsteoSight can
be installed in the cloud, via a host integration
platform, which may be within the existing
secured network of a clinical site. OsteoSight
consists of a number of microservices deployed
through container orchestration services like
Docker.

existing secured network. All traffic to and
from Rho can be monitored and controlled
by you. Rho consists of a DICOM node,
database and a number of microservices
deployed through container orchestration
services like Docker Compose and
Kubernetes.

To opportunistically analyze standard
anteroposterior (AP) radiographs of the hip or
pelvis performed in patients aged 50 years and
older.
The algorithm presents a binary output to
indicate whether the patient likely has low BMD
at the femoral neck. An OsteoSight Report is

To opportunistically analyze standard
anteroposterior (AP) radiographs of the
spine, chest, pelvis, knee, hand or wrist
performed in patients aged 50 years and
older.
The algorithm presents a binary output to
indicate whether or not the patient likely has
low BMD at either the femoral neck or L1-


generated for positive cases that can be sent
back to the PACS for physician interpretation.
OsteoSight provides a notification in the form of
a report to aid radiologists and/or physician
interpreters to identify patients with possible low
bone mineral density (BMD) at the femoral neck
to prompt a clinical assessment of bone health.

L4. A Rho Report is generated for positive
cases that can be sent back to the PACS for
physician interpretation or viewed through a
browser-based interface.
Rho provides a notification in the form of a
report to aid radiologists and/or physician
interpreters in identifying patients with
possible low bone mineral density (BMD) at
the femoral neck to prompt a clinical
assessment of bone health.

Machine Learning
Supervised Machine Learning (ML)
Supervised Machine Learning (ML)
Same

DICOM Source (e.g., imaging device,
intermediate DICOM node, PACS system, etc.)

Clinical output
Results Report
Results Report
Same

Clinical Finding
Patients at risk of low BMD
Patients at risk of low BMD
Same


Result output through a report with no
annotation of the original image

Results will be presented to a physician in a
medical setting, typically via a Picture
Archiving and Communication System (PACS).

OsteoSight was developed under design
controls in compliance with IEC 62366,
‘Application of usability engineering to medical
devices’, and FDA guidance ‘Applying Human
Factors and Usability Engineering to Medical
Devices Guidance for Industry and Food and
Drug Administration Staff’.

Rho was developed under design controls
and approved based on its compliance to
the FD&C Act including validation of its
interfaces and risk controls.

OsteoSight was developed in accordance with
applicable design standards;
ISO 14971, BS EN 62366 and IEC 62304.

Materials
N/A – Software device only.
N/A – Software device only.
/


Biocompatibility
N/A – Software device only.
N/A – Software device only.
/

Compatibility with
the environment
and other devices

OsteoSight processes DICOM images in a
software-only configuration and does not
require physical integration with imaging
equipment.
OsteoSight has been validated for its intended
use and operational environment.

Rho processes DICOM images in a
software-only configuration and does not
require physical integration with imaging
equipment.

Sterility
N/A – Software device only.
N/A – Software device only.
/

Electrical safety
N/A – Software device only.
N/A – Software device only.
/

Mechanical safety
N/A – Software device only.
N/A – Software device only.
/

Chemical safety
N/A – Software device only.
N/A – Software device only.
/

Thermal safety
N/A – Software device only.
N/A – Software device only.
/

Radiation safety
N/A – Software device only.
N/A – Software device only.
/


Time Between Scans (Median [IQR]
days)(min-max)

Body mass index (BMI), Dual-energy X-ray absorptiometry (DXA), bone mineral density (BMD).


Population N Specificity Sensitivity AUC

Table 3. Performance Characterization of OsteoSight in Intended Use Population.


Population N AUC Sensitivity Specificity

Subset of OsteoSight
Intended Use Population
that produced a result


Group
N
AUC (95% CI)
Sensitivity (95% CI)
Specificity (95% CI)


population in which OsteoSight generated a result.


population in which OsteoSight generated a result


Classification Description
21 CFR §
Product Code

System, imaging, pulsed doppler,
ultrasonic

System, imaging, pulsed echo,
ultrasonic

Transducer, ultrasonic, diagnostic
892.1570
ITX

Automated Radiological Image
Processing Software

Common Name Diagnostic Ultrasound System and Transducers


System, imaging, pulsed doppler,
ultrasonic

Catheter, Ultrasound, Intravascular
870.1200
OBJ*


EPIQ & Affiniti Series Diagnostic Ultrasound

Abdominal, Cardiac Adult, Cardiac other (Fetal),
Cardiac Pediatric, Cerebral Vascular, Cephalic
(Adult), Cephalic (Neonatal), Fetal/Obstetric,
Gynecological, Intraoperative (Vascular),
Intraoperative (Cardiac), intra-luminal, intra-
cardiac echo, Musculoskeletal (Conventional),
Musculoskeletal (Superficial), Ophthalmic, Other:
Urology, Pediatric, Peripheral Vessel, Small Organ
(Breast, Thyroid, Testicle), Transesophageal
(Cardiac), Transrectal,
Transvaginal, Lung

LVivo platform is
intended for non-
invasive processing of
ultrasound images to
detect, measure, and
calculate relevant
medical parameters of
structures and function
of patients with
suspected disease. In
addition, it has the ability
to provide Quality Score
feedback

Trained healthcare professionals
Intended for sonographers, physicians who
operate and maintain your product.
Before use of the system and user information,
the user must be familiar with ultrasound
techniques. Sonography training and clinical
procedures are not included in the User Manual or
with the EPIQ and Affiniti Series Diagnostic
Ultrasound System.

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

USA FDA
Class II
Class II
Class II
No change

Ultrasonic pulsed doppler imaging
system

Medical image
management and
processing system

Affiniti Series Diagnostic Ultrasound Systems. The subject devices are substantially equivalent to the predicate devices (K240850).


System Feature: SVS v2 Contrast
K240850
EF K243235

Feature
Proposed Device
Predicate Device
Comparison

Diagnostic ultrasonic transducer
Ultrasonic pulsed echo imaging system
Diagnostic intravascular catheter
Medical image management and processing
system

Reusable-
Yes
Yes
No, software-feature
No change

Duration of use
Limited (≤ 24 hours)
Limited (≤ 24 hours)
N/A, software-feature
No change

Smart View Select is an automated software
feature that assists the user in selection of images
for analysis with the existing Philips AutoStrain LV
or 2D Auto LV (K240850) application in Adult Echo
Transthoracic (TTE) examination.
Users can launch existing 2D Auto EF; 2D Auto EF
Adv (submitted K251110) or AutoStrain LV; or 2D
Auto LV (both K240850) with the set of images that
have been automatically selected without the need
to review the acquired images and manually select
the views. Users may select 2D Auto EF Adv, to
process the selected views by SVS v2 Contrast.
SVS v2 Contrast prioritizes the contrast image pair;
however, if an appropriate pair of contrast images
is not found, then Auto EF Adv may select non-
contrast images. The manual approach to select
views is still available and
the user can override automatically selected
images from SVS v2 Contrast.

Predicate integrates the LVivo seamless
algorithm (K212466) to introduce Smart View
Select (SVS) on the EPIQ Series Diagnostic
Ultrasound System. SVS is an automated
software feature that assists the user in
selection of optimal images for analysis with the
existing Pillips AutoStrain LV or 2D Auto LV
(both K240850)
The LVivo contains the functionality introduced
for
(1)automatic selection of 4CH,2CH, and 3CH
views for left ventricle (LV) analysis or (2)
(semi- automated segmental wall motion
evaluation of the left ventricle (LV).

LVivo platform is
intended for non-
invasive processing of
ultrasound images to
detect, measure, and
calculate relevant
medical parameters of
structures and function
of patients with
suspected diseases. In
addition, it has the
ability to provide Quality
Score feedback

The algorithm is
revised to include the
selection of optimal
images for analysis
when contrast is used
in routine TTE exams.


Outcomes Comparison
(n)
Difference
Lower LoA (95% CI)
Upper LoA (95% CI)

Biplane EF - Manually Selected (Ground Truth)


Outcomes Comparison
N
Pearson's correlation
p-Value

EF–SVS Selected (Automated) vs EF–Manually Tracing


BrightHeart
7-11 boulevard Haussmann
Paris 75009, France

Christophe Gardella
Chief Technical Officer
Tel. +0033686543950
Email. christophe@brightheart.fr

Submission Correspondent:
Christophe Gardella


Device Trade Name:
BrightHeart View Classifier

Device Common Name:
Fetal ultrasound view classifier

21 CFR §892.2050, Medical image management and
processing system