for informational
purposes only). The
estimated calcium
segmentation can be
viewed by the physician
in a diagnostic image
viewer. The physician’s
standard method for
viewing unaltered chest
CT scans in PACS will
remain available to them
even if the subject
device is being used.
However, the physician
will also have an option
to view the calcium
segmentation estimated
by the subject device as
a separate series within
PACS.

only). The estimated
visual output can be
viewed by the
physician in a
diagnostic image
viewer. The physician’s
standard method for
viewing unaltered chest
CT scans in PACS will
remain available to
them even if the subject
device is being used.
However, the physician
will also have an option
to view the visual
output estimated by the
subject device as a
separate series within
PACS.

Optional to copy result to
clipboard, insert in report,
DICOM Secondary
Capture

Yes, estimated calcification
volume (mm3) score and
binary output
(presence/absence)

Yes, Coronary
Calcium Detection
Category and exact
Agatston score
4 detection categories

Yes, estimated exact
Agatston-equivalent
score and binary output
(presence/absence)

Intended location
Medical facility
Medical facility
Medical facility
Same


Proprietary Name
Bunkerhill Contrast AVC

Classification Name
Computed tomography x-ray system


Proposed Device: Bunkerhill
Predicate Device: Bunkerhill

Bunkerhill Contrast AVC is a
software device intended for use
in detecting presence and
estimating quantity of aortic
valve calcification for adult
patients aged 40 years and
above. The device automatically
analyzes non-gated, contrast-
enhanced chest computed
tomography (CT) images
collected during clinical care
and outputs the region of
interest (intended for
informational purposes only)
and quantification of detected
calcium.
The output of the subject device
is made available to the
physician on-demand as part of
his or her standard workflow.
The device-generated
quantification can be viewed in
the patient report at the
discretion of the physician, and
the physician also has the option
of viewing the device- generated
calcium region of interest in a
diagnostic image viewer. The
subject device output in no way
replaces the original patient
report or the original non-gated,
contrast-enhanced CT scan; both
are still available to be viewed
and used at the discretion of the
physician.

Bunkerhill AVC is a software
device intended for use in
detecting presence and
estimating quantity of aortic
valve calcification for adult
patients aged 40 years and
above. The device
automatically analyzes non-
gated, non- contrast chest
computed tomography (CT)
images collected during
clinical care and outputs the
region of interest (intended
for informational purposes
only) and quantification of
detected calcium.
The output of the subject
device is made available to
the physician on- demand as
part of his or her standard
workflow.
The device-generated
quantification can be viewed
in the patient report at the
discretion of the physician,
and the physician also has
the option of viewing the
device- generated calcium
region of interest in a
diagnostic image viewer. The
subject device output in no
way replaces the original
patient report or the original
non- gated, non- contrast CT
scan; both are still available

Table 1: Substantial Equivalence-Intended Use Table


to be viewed and used at the
discretion of the physician.
The device is intended to
provide information to the
physician to provide
assistance during review of
the patient’s case.
Results of the subject device are
not intended to be used on a
stand- alone basis and are solely
intended to aid and provide
information to the physician. In
all cases, further action taken on
a patient should only come at
the recommendation of the
physician after further reviewing
the patient’s results.


Proposed Device:
Bunkerhill Contrast AVC

Predicate Device:
Bunkerhill AVC (K243229)

Modality
Computed tomography (CT)
Computed tomography (CT)
Same

Contrast-enhanced, Non-cardiac-
gated CT scan

Slice thickness
Up to 5 mm
Up to 5 mm
Same

Visual output in the form a
Region of Interest or ROI
(intended for informational
purposes only). The estimated
visual output can be viewed by
the physician in a diagnostic
image viewer. The physician’s
standard method for viewing
unaltered chest CT scans in
PACS will remain available to
them even if the subject device is
being used. However, the
physician will also have an option
to view the visual output
estimated by the subject device as
a separate series within PACS.

Optional to copy result to
clipboard, insert in report,
DICOM Secondary Capture

Yes, estimated calcification
volume (mm3) score and binary
output (presence/absence)

Yes, estimated exact Agatston-
equivalent score and binary output
(presence/absence)


Intended location
Medical facility
Medical facility
Same


Subject Device
Philips Medical Systems'
AV Cardiac CT

Predicate Device
Philips Medical Systems'
Spectral CT Applications
(K150665)

Reference device GE
Medical Systems’
CardIQ Suite

Device Class
Class II
Class II
Class II
Identical

Product Code
JAK, QIH (subsequent)
JAK, LLZ (subsequent)
JAK, LLZ (subsequent)
Similar

Computed tomography
x-ray system (primary).
Medical image
management and
processing system
(subsequent).

Computed tomography
x-ray system (primary)
Medical image
management and
processing system
(subsequent)


The AV Cardiac CT
applications are
intended to assist the
user in viewing,
processing, analysis of
CT datasets and in
preparation of cardiac
interventions.
The CT Coronary
Analysis application is
indicated to assist
radiologists,
cardiologists, and 3D
technologists in the
analysis of coronary
artery anatomy for
patients with suspected
or diagnosed cardiac
disease including
coronary artery disease.
The CT Functional
Analysis application is
indicated to assist
radiologists,
cardiologists, and 3D
technologists in the
analysis of heart
anatomy and function,
for patients with
suspected or diagnosed
cardiac diseases.

The Philips Spectral CT
Applications support
viewing and analysis of
images at energies
selected from the
available spectrum in
order to provide
information about the
chemical composition of
the body materials
and/or contrast agents.
The Spectral CT
Applications provide for
the quantification and
graphical display of
attenuation, material
density, and effective
atomic number. This
information may be
used by a trained
healthcare professional
as a diagnostic tool for
the visualization and
analysis of anatomical
and pathological
structures.
The Spectral enhanced
Advanced Vessel
Analysis (sAVA)
application is intended
to assist clinicians in
viewing and evaluating
CT images, for the
inspection of contrast-
enhanced vessels.
The Spectral enhanced
Comprehensive Cardiac
Analysis (sCCA)
application is intended

CardlQ Suite is a non-
invasive software
application designed
to provide an
optimized application
to analyze
cardiovascular
anatomy and
pathology based on
2D or 3D CT cardiac
non contrast and
angiography DICOM
data from
acquisitions of the
heart. It provides
capabilities for the
visualization and
measurement of
vessels and
visualization of
chamber mobility.
CardlQ Suite also aids
in diagnosis and
determination of
treatment paths for
cardiovascular
diseases to include,
coronary artery
disease, functional
parameters of the
heart, heart
structures and
follow-up for stent
placement, bypasses
and plaque imaging.
CardlQ Suite provides
calcium scoring, a
non-invasive
software application,
that can be used with


to assist clinicians in
viewing and evaluating
cardiovascular CT
images.
The Spectral enhanced
Tumor Tracking (sTT)
application is intended
to assist clinicians in
viewing and evaluating
CT images, for the
inspection of tumors.

non-contrasted
cardiac images to
evaluate calcified
plaques in the
coronary arteries,
heart valves and
great vessels such as
the aorta. Calcium
Scoring may be used
to monitor the
progression/regressio
n of calcium in
coronary arteries
overtime, which may
aid in the prognosis
of cardiac disease.

Cardiovascular anatomy
(heart and coronary vess
els)

Cardiovascular
anatomy
(heart and coronary v
essels)

Coronary
artery
segmentation
including
automated
centerline
extraction,
vessel
labelling,
lumen, and

Yes
Includes new algorithm
for centerline extraction
(CNN - deep learning
component included),
updated vessel labelling
algorithm (model based)
and new lumen
segmentation algorithm
(KNN model). In

Yes
Includes legacy
algorithms (non-AI) for
centerline extraction,
vessel labelling, lumen
and wall segmentation.


Proprietary Name
AI Platform 2.2 (AIP002)

Automated Radiological Image Processing Software


Proprietary Name
AI Platform 2.0 (AIP002)


Predicate Device:
Exo AI platform 2.0
(K240953)

AI Platform 2.2 is intended for
noninvasive processing of ultrasound
images to detect, measure, and
calculate relevant medical parameters
of structures and function of patients
with suspected disease. In addition, it
can provide Quality Score feedback to
assist healthcare professionals, trained
and qualified to conduct
echocardiography, abdominal, and
lung ultrasound scans in the current
standard of care while acquiring
ultrasound images. The device is
intended to be used on images of
adult patients.

AI Platform 2.0 is intended for
noninvasive processing of ultrasound
images to detect, measure, and
calculate relevant medical parameters
of structures and function of patients
with suspected disease. In addition, it
can provide Quality Score feedback to
assist healthcare professionals, trained
and qualified to conduct
echocardiography and lung ultrasound
scans in the current standard of care
while acquiring ultrasound images.
The device is intended to be used on
images of adult patients.

Single and Multi-frame ultrasound
images

Same as subject device. No changes
were made.

Comparison of Technological Characteristics with the Predicate Device


Ultrasound image processing software
implementing artificial intelligence,
including non-adaptive machine
learning algorithms trained with clinical
data intended for non-invasive
analysis of ultrasound data

Deep Convolutional Neural Networks
for Segmentation, Landmark Detection
and Classification

LVEF
IVC Minimum diameter on inspiration
and Maximum diameter on expiration
Myocardium wall thickness
(Interventricular Septum and Posterior
wall) from Plax view

Absence/presence of A-lines
B-lines count

Retrospectively
recording of
Diagnostic quality clip

AI modules are an
accessory to
compatible general
purpose diagnostic
ultrasound systems


- Spine support respiratory (Cushion) as a part
of BM Spine Coil Set 1.5T (including new
surface material)

New
same as predicate,
but with new Upgrade
Option

Other
Modifications
and / or Minor
Changes

Modified
same as predicate,
but with new claim
introduced

- PETRA (new claim for the existing sequence)


New
compared to predicate,
same as reference
(K252838)
(transferred without
modifications)

- BioMatrix Dockable Table
with / without eDrive
- Comfort Sound: Cushion

Modified
compared to predicate,
same as reference
(K252838)
(transferred without
modifications)

- Comfort Sound: BM Head/Neck Coil
- Relocatable Option

(K252838), to the subject devices without any modifications:


New
compared to predicate,
same as reference
(K252838)
(transferred without
modifications)

- BioMatrix Motion Sensor (SAMER)
- CS_VIBE
- SPAIR FatSat Improvements:
SPAIR “Abdomen & Pelvis” mode and SPAIR
Breast mode
- Deep Resolve Boost for FL3D_VIBE and
SPACE
- Deep Resolve Sharp for FL3D_VIBE and
SPACE
- Preview functionality for Deep Resolve Boost
- myExam Implant Suite
- GRE_PC
- Open Recon 2.0
- Deep Resolve Boost for TSE
- “MTC Mode” for SPACE

- Off-Center Planning Support
- Flip Angle Optimization (Lock TR and FA)
- ID Gain (re-naming)
- Marketing bundle “myExam Companion”


Predicate Devices
FDA Clearance Number
Product
Manufacturer

Siemens Shenzhen
Magnetic Resonance
Ltd.

are substantially equivalent to the following predicate devices:


Reference Device
FDA Clearance Number
Product
Manufacturer


Flow.Ace with
Flow.Ace with
Flow.Plus with
Flow.Neo with

Yes, same as predicate,
but with relocatable option (same
as reference)

RF System
Yes, same as predicate device
Yes
Yes

Yes, same as predicate device,
but with a new Gradient
Configuration Upgrade from B60 to
G60

Yes, new compared to predicate,
but same as reference:
- BioMatrix Dockable Table with
/ without eDrive

Computer
Yes, same as predicate device
Yes
Yes

Yes, modified compared to
predicate, but same as reference:
- Comfort Sound for BM
Head/Neck Coil


Yes, modified compared to
predicate, but same as reference:
SE:
- with ID Gain
TSE:
- with Deep Resolve Boost
improvement
- with Preview functionality for
Deep Resolve Boost
- with SPAIR "Abdomen&Pelvis"
mode and SPAIR Breast mode
- with ID Gain
TSE_DIXON:
- with ID Gain
HASTE:
- with Deep Resolve Boost (e.g.
preview functionality)
- with SPAIR “Abdomen&Pelvis”
mode and SPAIR Breast mode
SPACE:
- with "MTC Mode" improvement -
with Deep Resolve Boost (e.g.
preview functionality)
- with Deep Resolve Sharp
- with SPAIR “Abdomen&Pelvis”
mode and SPAIR Breast mode
BLADE:
- with SPAIR “Abdomen&Pelvis”
mode and SPAIR Breast mode


GRE-
based/Steady-
State Pulse
Sequence Types

Yes, modified compared to
predicate, but same as reference:
FL3D_VIBE:
- with Deep Resolve Boost (e.g.
preview functionality)
- with Deep Resolve Sharp
- with Compressed Sensing (CS-
Vibe)
- with SPAIR “Abdomen&Pelvis”
mode and SPAIR Breast mode
TurboFLASH (TFL):
- with BioMatrix Motion Sensor
(SAMER)
GRE_PC:
- in-plane generalized auto
calibrating parallel acquisition
(GRAPPA)-based SMS formulation

Yes, modified compared to
predicate, but same as reference:
EP2D_DIFF:
- with Deep Resolve Boost (e.g.
preview functionality)
- with SPAIR “Abdomen&Pelvis”
mode and SPAIR Breast mode
RESOLVE:
- with SPAIR “Abdomen&Pelvis”
mode and SPAIR Breast mode

Yes, modified compared to
predicate, but same as reference:
- with Flip Angle Optimization
(Lock TR and FA)

myExam
Yes, same as predicate device
Yes
Yes

Yes, modified compared to
predicate, but same as reference:
- myExam Implant Suite

Visualization
Yes, same as predicate device
Yes
Yes

Communication
Yes, same as predicate device
Yes
Yes


Yes, new compared to predicate,
but same as reference:
- Open Workflow Framework
Yes, modified compared to
predicate, but same as reference:
- Open Recon Framework

Yes, new compared to predicate,
but same as reference:
- Eco Power Mode Pro

Yes, same as predicate, but new
claim introduced
- PETRA
Yes, modified compared to
predicate, but same as reference:
- Off-Center Planning Support
- Marketing bundle “myExam
Companion”


[1] Polak D, Splitthoff DN, Clifford B, Lo W-C, Huang SY, Conklin J,
Wald LL, Setsompop K, Cauley S: Scout accelerated motion estimation
and reduction (SAMER); Magn Reason Med 87:163-178 (2022).
https://doi.org/10.1002/mrm.28971

[2] Lang M, Tabari A, Polak D, Ford J, Clifford B, Lo W-C, Manzoor K,
Splitthoff DN, Wald LL, Rapalino O, Schaefer P, Conklin P, Cauley S,
Huang SY: Clinical Evaluation of Scout Accelerated Motion Estimation
and Reduction Technique for 3D MR Imaging in the Inpatient and
Emergency Department Settings; Am J Neuroradiol 44:125-133 (2023).
https://doi.org/10.3174/ajnr.A7777

[3] Vreemann, S., Rodriguez-Ruiz, A., Nickel, D., Heacock, L., Appelman,
L., van Zelst, J., Karssemeijer, N., Weiland, E., Maas, M., Moy, L., Kiefer,
B., & Mann, R. M. (2017). Compressed Sensing for Breast MRI:
Resolving the Trade-Off Between Spatial and Temporal Resolution.
Investigative Radiology, 52(10), 574–582.
https://doi.org/10.1097/rli.0000000000000384

[4] Grodzki DM, Jakob PM, Heismann B. Ultrashort echo time imaging
using pointwise encoding time reduction with radial acquisition (PETRA).
Magn Reson Med. 2012 Feb;67(2):510-8. doi: 10.1002/mrm.23017. Epub
2011 Jun 30. PMID: 21721039.

[5] Li C, Magland JF, Zhao X, Seifert AC, Wehrli FW. Selective in vivo
bone imaging with long-T2 suppressed PETRA MRI. Magn Reson Med.
2017 Mar;77(3):989-997. doi: 10.1002/mrm.26178. Epub 2016 Feb 24.
PMID: 26914767.


Recogniti
on Product
Title of Standard
Reference
Standards

Medical electrical equipment -
Part 1: General requirements for
basic safety and essential
performance (IEC 60601-
1:2005, MOD)

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

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

Medical devices - Application of
risk management to medical
devices

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

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

Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices

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

Digital Imaging and
Communications in Medicine
(DICOM)

Biological evaluation of medical
devices - part 1: evaluation and
testing within a risk
management process.
(Biocompatibility)


261 Madison Avenue, 9th Floor
New York, NY 10016

Kevin Robinson
VP of Regulatory Affairs, Radformation


AutoContour, AutoContouring, AutoContour Agent,
AutoContour Cloud Server

Medical image management and processing system


Table 11: Substantial Equivalence AutoContour Model RADAC V5 vs. AutoContour Model
RADAC V4 (K242729)

Subject Device:
AutoContour Model
RADAC V5

Predicate Device:
AutoContour Model
RADAC V4 (K242729)

Reference Device
Limbus Contour (K241837)
Used for Verification

AutoContour vs. PredicateDevices: Technological Characteristics

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

Limbus Contour is a
software-only medical
device intended for use by
trained radiation
oncologists, dosimetrists,
and physicists to derive
optimal contours for input to
radiation treatment
planning.

Any patient type for whom
relevant modality scan
data is available.

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

Design: Data
Visualization/G
raphical User
Interface

Contains both an
automated processing
component and Data
Visualization / Graphical
User Interface

Contains an automated
processing component.

Design: View
manipulation
and Volume
rendering

Window and level, pan,
zoom, cross-hairs, slice
navigation, fused views.


Manual and Automatic
Rigid registration.
Automatic Deformable
Registration

AutoContour vs. Predicate and Reference: Model Comparison

CT or MR input for
contouring of anatomical
regions: Head and Neck,
Thorax, Abdomen and
Pelvis.
Machine learning based
contouring of 420
CT-based and 62
MR-based models and
manual ROI manipulation
CT Models:
● A_Aorta
● A_Aorta_Asc
● A_Aorta_Dsc
● A_Brachiocephls
● A_Carotid_L
● A_Carotid_R
● A_Celiac*
● A_Circumflex_L
● A_Coronary_2d_R
● A_Coronary_L
● A_Coronary_R
● A_LAD
● A_Mesenteric_S*
● A_Pulmonary*
● A_Subclavian_L
● A_Subclavian_R
● Atrium_L*
● Atrium_R*
● AV_Node
● Barrigel™
● BileDuct_Common
● Bladder*
● Bladder_CBCT*
● Bladder_F*
● Body*
● Body+Mask*
● Bone_Hyoid*
● Bone_Ilium*
● Bone_Ilium_L*
● Bone_Ilium_R*
● Bone_Ischium_L*
● Bone_Ischium_R*
● Bone_Mandible*
● Bone_Pelvic*
● Bone_Pterygoid_L
● Bone_Pterygoid_R

CT or MR input for
contouring of anatomical
regions: Head and Neck,
Thorax, Abdomen and
Pelvis.
Machine learning based
contouring of 260
CT-based and 35
MR-based models and
manual ROI manipulation
CT Models:
● A_Aorta
● A_Aorta_Asc
● A_Aorta_Dsc
● A_Brachiocephls
● A_Carotid_L
● A_Carotid_R
● A_Coronary
● A_LAD
● A_Pulmonary
● A_Subclavian_L
● A_Subclavian_R
● Atrium_L
● Atrium_R
● Bladder
● Bladder_F
● Bone_Hyoid
● Bone_Ilium_L
● Bone_Ilium_R
● Bone_Mandible
● Bone_Pelvic
● Bone_Skull
● Bone_Sternum
● Bone_Teeth
● Bowel
● Bowel_Bag
● Bowel_Large
● Bowel_Small
● BrachialPlex_L
● BrachialPlex_R
● Brain
● Brainstem
● Breast_L
● Breast_R
● Breast_Prone
● Bronchus
● BuccalMucosa

CT or MR input for
contouring of anatomical
regions: Head and Neck,
Thorax, Abdomen and
Pelvis.
CT Models
● A_Aorta
● A_Aorta_Base
● A_Aorta_I
● A_Aorta_l
● A_Celiac
● A_LAD
● A_Mesenteric_S
● A_Pulmonary
● Atrium_L
● Atrium_R
● Bag_Bowel
● Bag_Bowel_Extend
● Bag_Bowel_Full
● Bag_Bowel_S
● Bladder
● Bladder_CBCT
● Bladder_HDR
● Body
● Body+Mask
● Bone_Hyoid
● Bone_Hyoid
● Bone_Ilium_L
● Bone_Ilium
● Bone_Ilium_L
● Bone_Ilium_R
● Bone_Ischium_L
● Bone_Ischium_R
● Bone_Mandible
● Bone_Pelvic
● BoneMarrow_Pelvic
● Bowel
● Bowel_Bag
● Bowel_Bag_Extend
● Bowel_Bag_Full
● Bowel_Bag_Superior
● Bowel_Extend
● Bowel_Full
● Bowel_HDR
● Bowel_S
● Bowel_Superior
● BrachialPlex_L
● BrachialPlex_R
● BrachialPlexs
● Brain
● Brainstem
● Breast_Implant_L
● Breast_Implant_R
● Breast_L


● Bone_PubicSymphys* ● Carina ● Breast_R

● Bowel_Bag_F ● Chestwall_RC_L ● Cerebellum

● Bowel_Large_F ● Clavicle_R ● Chestwalls

● BrachialPlexs ● Cornea_R ● Colon_Sigmoid

● Brain ● Dental_Artifact ● Colon_Sigmoid_HDR

● Breast_Implant_L* ● Ear_Internal_L ● Duodenum

● Breast_Implant_R* ● Ear_Internal_R ● Esophagus

● Bronchus ● Femur_RTOG_L ● Glnd_Lacrimal_L

● BuccalMucosa ● Femur_RTOG_R ● Glnd_Lacrimal_R

● Canal_Anal_F* ● GallBladder ● Glnd_Thyroid

● Cardiac_Avoidance_Area ● Genitals_F ● GreatVes

● CaudaEquina ● Glnd_Lacrimal_L ● Heart+A_Pulm

● Cerebellum* ● Glnd_Submand_R ● Humerus_R

● Chestwall_Anat_R* ● HDR_Rectum ● Kidneys


● CorpusCallosum ● Larynx_SG ● LN_Neck_IA6

● Esophagus ● LN_Ax_L1_ESTRO_L ● LN_Neck_IV_L

● External ● LN_Ax_L1_ESTRO_ ● LN_Neck_IV_R

● Femur_RTOG_R* ● LN_Ax_L3_ESTRO_ ● Lungs

● GallBladder ● LN_Ax_L3_R ● Musc_PecMinor_L

● Glnd_Lacrimal_R* ● LN_IMN_R ● OpticChiasm

● Glnd_Thyroid* ● LN_Inguinofem_L ● Optics

● GreatVessels* ● LN_Inguinofem_R ● Pancreas

● HDR_Canal_Anal* ● LN_Neck_IA ● PenileBulb

● HDR_Colon_Sigmoid* ● LN_Neck_IB_L ● Pericardium

● HDR_Rec-Canal_MR ● LN_Neck_IB-V_L ● Pituitary

● HDR_Rectum ● LN_Neck_IB-V_R ● Prostate

● HDR_Urethra* ● LN_Neck_II_R ● Prostate+SeminalVes

● Heart* ● LN_Neck_II-IV_L ● PubicSymphys

● Heart_Prone ● LN_Neck_II-IV_R ● Rectum

● Colon_Sigmoid_F ● Kidney_Outer_L ● LN_IMN_R


● InternalAuditoryCanal_R*
●
LN_Neck_VIIA_R
● S

● LN_Ax_L1_ESTRO_2d_L
●
Lobe_Temporal_L
● V

● LN_Ax_L1_ESTRO_2d_R
●
Lobe_Temporal_R
● V

● LN_Ax_L2_ESTRO_2d_L*
●
Musc_Constrict
● V

● LN_Ax_L2_ESTRO_2d_R*
●
Musc_Iliopsoas_L
● V

● LN_Ax_L2_ESTRO_L
●
Musc_Iliopsoas_R
● V

● InternalAuditoryCanal_L* ● LN_Neck_VIIA_L ● SeminalVes_CBCT


● OpticTract_R
● PenileBulb*
● PenileBulb_TRUFI
● Pituitary
● Pons
● Prostate*
● Rectal_Spacer
● Rectum*
● Retina_L*
● Retina_R*
● SeminalVes*
● Sinuses
● SpinalCord_Cerv
● Tentorium
● Thalamus
● Urethra
● Ventricle_Brain

Design:
Region/volume
of interest
measurements
and size
measurements

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

No built-in reporting,
supports exporting DICOM
RTSTRUCT,
REGISTRATION and
DOSE files for output.

No built-in reporting,
supports exporting DICOM
RTSTRUCT files for output

Compatibility
with the
environment
and other
devices

Compatible with data from
any DICOM compliant
scanners for the
applicable modalities.
Agent Uploader
component compatible
with Microsoft Windows.
Cloud-based automatic
contouring service
compatible with Linux.

No Limitation on scanner
model, DICOM 3.0
compliance required.


Web application
server-based application
compatible with Linux.

Operating System Windows
10 /
Windows Server 2016 and
Above


Table 5: CT External Clinical Dataset References

Model Group
Data Source ID
Data Citation

Afua A. Yorke, Gary C. McDonald, David Solis Jr., Thomas Guerrero. (2019)
Pelvic Reference Data. The Cancer Imaging Archive. DOI:
10.7937/TCIA.2019.woskq5oo

Martin Vallières, Emily Kay-Rivest, Léo Jean Perrin, Xavier Liem, Christophe
Furstoss, Nader Khaouam, Phuc Félix Nguyen-Tan, Chang-Shu Wang, Khalil
Sultanem. (2017). Data from Head-Neck-PET-CT. The Cancer Imaging Archive.
doi: 10.7937/K9/TCIA.2017.8oje5q00

Hong, J., Reyngold, M., Crane, C., Cuaron, J., Hajj, C., Mann, J., Zinovoy, M.,
Yorke, E., LoCastro, E., Apte, A. P., & Mageras, G. (2021). Breath-hold CT and
cone-beam CT images with expert manual organ-at-risk segmentations from
radiation treatments of locally advanced pancreatic cancer [Data set]. The
Cancer Imaging Archive. https://doi.org/10.7937/TCIA.ESHQ-4D90

Aerts, H. J. W. L., Wee, L., Rios Velazquez, E., Leijenaar, R. T. H., Parmar, C.,
Grossmann, P., Carvalho, S., Bussink, J., Monshouwer, R., Haibe-Kains, B.,
Rietveld, D., Hoebers, F., Rietbergen, M. M., Leemans, C. R., Dekker, A.,
Quackenbush, J., Gillies, R. J., Lambin, P. (2019). Data From

model training were added to the image sets.


NSCLC-Radiomics [Data set]. The Cancer Imaging Archive.
https://doi.org/10.7937/K9/TCIA.2015.PF0M9REI

Yang, J., Sharp, G., Veeraraghavan, H., Van Elmpt, W., Dekker, A., Lustberg,
T., & Gooding, M. (2017). Data from Lung CT Segmentation Challenge (Version
3) [Data set]. The Cancer Imaging Archive.
https://doi.org/10.7937/K9/TCIA.2017.3R3FVZ08

Li, X., Abramson, R. G., Arlinghaus, L. R., Chakravarthy, A. B., Abramson, V.
G., Sanders, M., & Yankeelov, T. E. (2016). Data From QIN-BREAST (Version
2) [Data set]. The Cancer Imaging Archive.
https://doi.org/10.7937/K9/TCIA.2016.21JUEBH0
N/A- Testing data was shared from several institutions

N/A- Testing data was shared from 2 different institutions based in the United
States.

N/A- Testing data was shared from 1 institution based in the United States

N/A- Testing data was shared from several institutions in Australia


DSC values were calculated between ground truth contour data and AutoContour structures and

rated on the same DSC passing criteria used for the Training DSC validation. All structures

passed the minimum DSC criteria for small, medium and large structures with a mean

appropriateness of AutoContour structures generated on these scans was graded by clinical

experts. Autocontour structures were graded on a scale from 1 to 5 where 5 refers to contour

requiring no additional edits, and 1 refers to a score in which full manual re-contour of the

structure would be required. An average score >= 3 was used to determine whether a structure

model would ultimately be beneficial clinically. An average rating of 4.37 was found across all

CT structure models demonstrating that only minor edits would be required in order to make the

structure models acceptable for clinical use.


Table 8: MR Training Data Results for AutoContour Model RADAC V5

models, and 0.72+/- 0.09 for small models.


Table 9: MR External Clinical Dataset References

Model Group
Data Source ID
Data Citation

Nyholm, Tufve, Stina Svensson, Sebastian Andersson, Joakim Jonsson, Maja

Sohlin, Christian Gustafsson, Elisabeth Kjellén, et al. 2018. “MR and CT Data

with Multi Observer Delineations of Organs in the Pelvic Area - Part of the Gold

Atlas Project.” Medical Physics 12 (10): 3218–21. doi:10.1002/mp.12748

Thummerer A, van der Bijl E, Galapon Jr A, Verhoeff JJ, Langendijk JA, Both S,

van den Berg CAT, Maspero M. 2023. SynthRAD2023 Grand Challenge dataset:

Generating synthetic CT for radiotherapy. Medical Physics, 50(7), 4664-4674.

N/A- Testing data was shared by 2 institutions utilizing MR Linacs for image

N/A- Testing data was shared by 1 institution in Canada

N/A- Testing data was shared by several institutions in Australia.

on image sets acquired that were unique to the training datasets.


For the Brain models, datasets acquired via data-use agreement from a clinical partner were

acquired containing 20 MR T1 Ax post (BRAVO) image scans acquired with a GE MR750w

scanner. Images had an average slice thickness of 1.6mm, In-plane resolution between 0.94

mm, and acquisition parameters of TR=5.98ms, TE=96.8s. Data for testing of the MR Pelvis

structure models were acquired from 2 publicly available datasets, which contained images of

patients with prostate or rectal cancer, as well as 1 dataset shared from 2 institutions utilizing an

Various scanner models and acquisition settings were used. Data for testing of the

MR Pelvis HDR structure models were acquired from 1 institution using two different slice

thicknesses, 1mm and 4mm, and two different in-plane resolutions, 1mm and .72mm.

DSC values were calculated between ground truth contour data and AutoContour structures and

rated on the same DSC passing criteria as was used for the training DSC validation. All

structures, but one passed the minimum DSC criteria for small, and medium structures with a


appropriateness of AutoContour structures generated on these scans was graded by clinical

experts. Autocontour structures were graded on a scale from 1 to 5 where 5 refers to contour

requiring no additional edits, and 1 refers to a score in which full manual re-contour of the

structure would be required. An average score >= 3 was used to determine whether a structure

model would ultimately be beneficial clinically. An average rating of 4.3 was found across all MR

structure models demonstrating that only minor edits would be required in order to make the

structure models acceptable for clinical use. The single structure that did not pass the minimum

DSC criteria was also evaluated by clinical experts and scored an average of 3.90, which

demonstrates the clinical effectiveness of this model.


Table 10: MR External Reviewer Results for AutoContour Model RADAC V5

demonstrates the clinical effectiveness of this model.


GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
3200 N Grandview Blvd
Waukesha, WI 53188 USA

GE Medical Systems (China) Co., Ltd.
No. 19, Changjiang Road,
Wuxi National High-Tech Development Zone,
214028 Jiangsu P. R. China

Lee Bush
Regulatory Affairs Director
GE HealthCare
T:(262)309-9429

Qingmeng Chen
Regulatory Affairs Leader
GE HealthCare
T: +86-18180590723

LOGIQ Vita, LOGIQ Vita Pro, LOGIQ Vita Express, LOGIQ Vita Plus,
LOGIQ Vita Power, LOGIQ S20, LOGIQ S20 Pro, LOGIQ S20
Express, LOGIQ S20 Plus, LOGIQ S20 Power

Common / Usual Name:
Diagnostic Ultrasound System

IYN (primary), IYO, ITX, QIH (secondary)
Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN;
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Medical Image Management and Processing System, 21 CFR 892.2050,
90-QIH

K253366 LOGIQ Fortis Diagnostic Ultrasound System

K250087 Vscan Air
K253370 LOGIQ Totus Diagnostic Ultrasound System

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


Proposed devices
use 14-inch Touch
Panel from LOGIQ
Totus (K253370).

23.8” High Resolution
HDU monitor
23.8-inch High Resolution
LCD monitor

23.8” High contrast LED
LCD monitor (or 23.8-
inch High Resolution LED
LCD monitor as an option)

The proposed
LOGIQ Vita uses
23.8inch HDU
monitor from
predicate LOGIQ
Fortis (K253366)
and the proposed
LOGIQ S20 uses
the 23.8inch LCD
monitor from
LOGIQ Totus
(K253370).

Ultrasound-Guided
Attenuation Parameter
(UGAP), Ultrasound
Guided Fat Fraction
(UGFF), Auto Preset
Assistant, Auto
Abdominal Color
Assistant 2.0, Auto
Abdominal Measure
Assistant (Renal, Aorta,
CBD), KOIS Lite

Identical* except
proposed devices
do not support
Koios Lite.

Biopsy w/guidelines, Scan
Assistant, ECG,
Footswitch, Histogram,

Identical except
proposed devices
do not support
UPS.

Comparison table of technological characteristics with predicate device(s):


Video out, Service
Modem, Respirometer,
RFID reader, UPS

DVR, CD/RW & DVD;
IP/DICOM, USB; DICOM
Compression, Modem,
Ethernet network, Multiple
and Multiple Frame send,
memory stick, Vscan Air
CL support, Send Images
via Email, ViewPoint on
LOGIQ

B/W & Color printing,
DVR, CD/RW & DVD;
IP/DICOM, USB; DICOM
Compression, Modem,
Ethernet network, Multiple
and Multiple Frame send,
memory stick, Koios DS
Connectivity, Vscan Air
CL support, Send Images
via Email, ViewPoint on
LOGIQ, Digital Expert
Connectivity

Identical except
proposed devices
do not support
Koios DS
Connectivity,
Digital Expert
Connectivity, or
integrated printers.

510(k) Premarket Notification Submission


Indications for Use
Please type in the marketing application/submission number, if it is known. This
K260746 ?
textbox will be left blank for original applications/submissions.
Please provide the device trade name(s). ?

Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions.

Please provide your Indications for Use below.

The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of
the body, to collect, display and analyse MR images and other real-time imaging procedures.
The indications for use are the following: imaging portions of the upper limb, including the hand, wrist,
forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee,
thigh, hip, imaging the temporomandibular joint, imaging the cervical, the thoracic, the lumbar and the
sacral sections as portions of the spinal column, and imaging the head.

Please select the types of uses (select one or both, as ~ Prescription Use (21 CFR 801 Subpart D)
D
applicable). Over-The-Counter Use (21 CFR 801 Subpart C)


Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)


Device Description Summary 21 CFR 807.92(a)(4)

'The S-scan Open device is a Magnetic Resonance (MR) system that produces cross-section images of the internal structures of the body.
Images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are
dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity
and chemical shift. When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful
information.
S-scan Open represents the evolution of its predicate device, the Esaote S-scan, cleared under K161973 (initial clearance K063207).
Compared to the predicate device, the following modifications have been introduced:
-Changes to the external design and shape, and an update of the electronics.
-Integration of the new software version MRI EVOlution 25, which provides compatibility with updated electronics, improvements in
cybersecurity management, bug fixing and optimization, and includes the following features: management of new coils, 3D viewer,
prone patient positioning management, SPED sequence, updated operating system, new graphical user interface, flow compensation
feature extension, operator-selectable gradients direction, DWI (Diffusion Weighted Imaging) sequence, 2D SST1 sequence, and
HyperClarity. Note: the subject device integrates the AI-based algorithm HyperClarity (SwiftMR, K230854) without any modification. The
algorithm is classified under a different regulation in its 510(K) and this is out-of-scope from the current submission of the subject device.
-Introduction of a patient alert system.
-Addition of new receiving Coils: XL flex L-Spine coil 10, Flex Coil 11, Knee Coil 21.
S-scan Open is substantially equivalent to the predicate device with respect to intended use, technical specifications, fundamental
scientific technology and principle of operation.

Intended Use/Indications for Use 21 CFR 807.92(a)(5)

Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code


The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and
analyse MR images and other real-time imaging procedures.
The indications for use are the following: imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and
shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh, hip, imaging the temporomandibular joint,
imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column, and imaging the head.

Indications for Use Comparison 21 CFR 807.92(a)(5)

The indications for use of the S-scan Open device are identical to those of the S-scan previously cleared (K161973).

Technological Comparison 21 CFR 807.92(a)(6)

S-scan Open is substantially equivalent to the S-scan already cleared (K161973), with regard to the technological characteristics, safety
and effectiveness.
The indented use of the S-scan Open remains unchanged from the predicate device.
S-scan Open and its predicate device have the same application environment and intended users.
S-scan Open employs the same fundamental scientific technology as the predicate device.
Core technical specifications, including the magnet characteristics and the filed strength, remain unchanged from the predicate device.
There are some differences summarized below.
Integration of the new software version MRI EVOlution 25 (F130001), which provides compatibility with updated electronics,
improvements in cybersecurity management, bug fixing and optimization, and includes the following features:
- HyperClarity, an AI-based algorithm (SwiftMR, K230854) integrated without any modification; note: the algorithm is classified under a
different regulation in its 510(k) and this is out-of-scope from the current submission of the subject device.
- 3D Viewer, already cleared with G-scan Brio (K180592).
- Prone Patient Positioning option already available on the cleared Magnifico (K251901).
- SPED (Spin-Echo with Dixon reconstruction technique) sequence: included in the “Spin Echo Fat & Water Separation” option, already
available on the cleared Magnifico (K251901).
- New Operating System Windows 10, already implemented on the cleared Magnifico (K251901).
- New Graphic User Interface, already available on the cleared Magnifico (K251901).
- Flow compensation, already available on S-scan (K161973) and extended to all FSE family sequences.
- Operator-selectable direction of imaging gradients, already available on the cleared Magnifico (K251901).
- DWI LS acquisition, already available on the cleared Magnifico (K251901).
- 2D SST1 sequence (Gradient Echo “steady state” sequence).
The software modifications consist of features previously cleared on Esaote MRI systems and incremental enhancements to existing
capabilities. These changes do not modify the intended use or the fundamental scientific technology.
New items listed below:
- Patient Alert System, providing the patient with a means to alert the operator if needed.
- New coils:
> XL flex L-Spine Coil is the same Esaote XL flex L-Spine Coil already cleared with the G-scan Brio (K142421).
> Knee coil 21 is the same Esaote Knee coil already available on the cleared Magnifico device (K251901).
> Flex coil is equivalent to the Esaote Hip coil n. 6 already cleared (K080968 and K042236).
All necessary performance tests have been performed to ensure the safety of the subject device. Verification and validation activities
results demonstrate that the S-scan Open device meets its intended use, meets all applicable safety and performance standards and
does not raise new questions of safety or effectiveness, compared to the predicate device.
Reference devices:
In addition to the predicate device (K161973), three legally marketed devices were used as reference devices to support specific
technological aspects:
- G-scan Brio (K180592)
- Magnifico Open (K251901)
- SwiftMR (K230854)

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Summary of Non-Clinical Tests:
The S-scan Open device has been evaluated and found to comply with the applicable requirements of the following standards:
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-2-33