The imaging features are then
synthesized by an artificial
intelligence algorithm into a
single ASPECTS (Alberta Stroke
Program Early CT) score.
Brainomix 360 e-ASPECTS is
indicated for evaluation of
patients presenting for
diagnostic imaging workup for
evaluation of extent of
disease. Extent of disease
refers to the number of
ASPECTS regions affected
which is reflected in the total
score. Brainomix 360 e-
ASPECTS provides information
that may be useful in the
characterization of ischemic
brain tissue injury during
image interpretation (within
24 hours from time last known
well).
Brainomix 360 e-ASPECTS
provides a comparative
analysis to the ASPECTS
standard of care radiologist
assessment by providing
highlighted ASPECTS regions
and an automated editable
ASPECTS score for clinician
review. Brainomix 360 e-
ASPECTS additionally provides
a visualization of the voxels
contributing to and excluded
from the automated ASPECTS
score and a calculation of the
voxel volume contributing to
ASPECTS score.
Limitations:
1. Brainomix 360 e-ASPECTS is
not intended for primary
interpretation of CT images. It
is used to assist physician
evaluation.
2. The ASPECTS score should
be only used for ischemic
stroke patients following the
standard of care.
3. Brainomix 360 e-ASPECTS
has only been validated and is

The imaging features are then
synthesized by an artificial
intelligence algorithm into a
single ASPECTS (Alberta Stroke
Program Early CT) Score.
Brainomix 360 e-ASPECTS is
indicated for evaluation of
patients presenting for
diagnostic imaging workup
with known MCA or ICA
occlusion, for evaluation of
extent of disease. Extent of
disease refers to the number
of ASPECTS regions affected
which is reflected in the total
score. Brainomix 360 e-
ASPECTS provides information
that may be useful in the
characterization of ischemic
brain tissue injury during
image interpretation (within 6
hours from time last known
well).
Brainomix 360 e-ASPECTS
provides a comparative
analysis to the ASPECTS
standard of care radiologist
assessment by providing
highlighted ASPECTS regions
and an automated editable
ASPECTS score for clinician
review. Brainomix 360 e-
ASPECTS additionally provides
a visualization of the voxels
contributing to the automated
ASPECTS score and the voxels
excluded from the automated
ASPECTS score.
Limitations:
1. Brainomix 360 e-ASPECTS is
not intended for primary
interpretation of CT images. It
is used to assist physician
evaluation.
2. Brainomix 360 e-ASPECTS
has been validated in patients
with known MCA or ICA
occlusion prior to ASPECTS
scoring.

intelligence algorithm into a
single ASPECT (Alberta Stroke
Program Early CT) Score.
Rapid ASPECTS is indicated for
evaluation of adult patients
presenting for diagnostic
imaging workup, for
evaluation of extent of
disease. Extent of disease
refers to the number of
ASPECTS regions affected
which is reflected in the total
score. This device provides
information that may be
useful in the characterization
of early ischemic brain tissue
injury for ischemic stroke
patient (typically, < 24 hours
since last known well) during
image interpretation following
the standard of care. Rapid
ASPECTS provides a
comparative analysis to the
ASPECTS standard of care
radiologist assessment using
the ASPECTS atlas definitions
and atlas display including
highlighted ROls and
numerical scoring. Rapid
ASPECTS presents the original
and annotated images for
concurrent reads.
Limitations:
1. The ASPECTS score should
be only used for ischemic
stroke patients following the
standard of care.
2. Rapid ASPECTS is an adjunct
tool and is not intended to
replace a clinicians review of
the original imaging or their
clinical judgement.
3. Physicians should not use
the CAD generated output as
the primary interpretation
without their concurrence.
Contraindications/Exclusions/
Cautions:


Reference Device
Rapid ASPECTS (v3)
(K232156)

Parameter
Brainomix 360 e-ASPECTS
Brainomix 360 e-ASPECTS

intended to be used in patient
populations aged over 21
years.
4. Brainomix 360 e-ASPECTS is
not intended for mobile
diagnostic use. Images viewed
on a mobile platform are
compressed preview images
and not for diagnostic
interpretation.
5. Brainomix 360 e-ASPECTS
has been validated and is
intended to be used on
Siemens Somatom Definition
scanners.
Contraindications/
Exclusions/Cautions:
• Patient motion: Excessive
patient motion leading to
artifacts that make the scan
technically inadequate
• Hemorrhagic
Transformation, Hematoma

3. Brainomix 360 e-ASPECTS is
not suitable for use on brain
scans displaying neurological
pathologies other than acute
stroke, such as tumors or
abscesses, hemorrhagic
transformation and
hematoma.
4. Use of Brainomix 360 e-
ASPECTS Module in clinical
settings other than brain
ischemia within 6 hours from
time last known well, caused
by known ICA or MCA
occlusions has not been
tested.
5. Brainomix 360 e-ASPECTS
has been validated and is
intended to be used on
Siemens Somatom Definition
scanners.
6. Brainomix 360 e-ASPECTS
has only been validated and is
intended to be used in patient
populations aged over 21
years.
7. Brainomix 360 e-ASPECTS is
not intended for mobile
diagnostic use. Images viewed
on a mobile platform are
compressed preview images
and not for diagnostic
interpretation.
Contraindications/
Exclusions/Cautions:
• Patient motion: Excessive
patient motion leading to
artifacts that make the scan
technically inadequate
• Hemorrhagic
Transformation, Hematoma

• Patient Motion: excessive
motion leading to artifacts
that make the scan
technically inadequate.
• Hemorrhagic
Transformation,
Hematoma
• Very thin or no Ventricles

Environment of use
Clinical/Hospital environment
Clinical/Hospital environment
Clinical/Hospital environment

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


Primary Users
Neuroradiologist/Clinician
Neuroradiologist/Clinician
Neuroradiologist/Clinician

Standard of Care
ASPECTS Scoring
ASPECTS Scoring
ASPECTS Scoring

Design: Modalities
for image processing
and visualization

ASPECTS regions, highlighted
by algorithms. Voxel-wise
analysis visualized as a heat
map.

ASPECTS Atlas ROIs,
highlighted by algorithms

Users must confirm ICA or
MCA occlusion prior to
accessing Brainomix 360 e-
ASPECTS results.

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

Standard off-the-shelf server
or virtual server

Acquires medical image data
from DICOM compliant
imaging devices and
modalities

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

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

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

Electrical Safety
N/A – Software only device
N/A – Software only device
N/A – Software only device

Mechanical Safety
N/A – Software only device
N/A – Software only device
N/A – Software only device

Chemical Safety
N/A – Software only device
N/A – Software only device
N/A – Software only device

Thermal Safety
N/A – Software only device
N/A – Software only device
N/A – Software only device

Radiation Safety
N/A – Software only device
N/A – Software only device
N/A – Software only device


provided for 139 exams (84%) in which the system correctly identified 4, 2


Classification Name:
Magnetic Resonance Diagnostic Device

Regulation Number:
90-LNH (Per 21 CFR § 892.1000)

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction
Processing Unit for MR


Vantage Galan 3T, MRT-3020, V10.0 with AiCE
Reconstruction Processing Unit for MR

Marketed By
Canon Medical Systems USA, Inc.


Vantage Galan 3T, MRT-3020, V9.0 with AiCE
Reconstruction Processing Unit for MR


Item
Subject Device:
Predicate Device:
Notes

Vantage Galan 3T, MRT-3020,
Vantage Galan 3T, MRT-3020,

with AiCE Reconstruction
with AiCE Reconstruction

Processing Unit for MR
Processing Unit for MR (K241496)


Operational Modes
Normal and 1st Operating Mode
Normal and 1st Operating Mode
Same

Allows screen access to 1st level
operating mode

4W/kg for whole body (1st
operating mode specified in IEC
60601-2-33:
2010+A1:2013+A2:2015)

Potential emergency
condition and means
provided for shutdown

Shutdown by Emergency Ramp
Down Unit for collision hazard for
ferromagnetic objects


Subject Device
Hologic, Inc.
Genius AI Detection 2.0

Predicate Device
Hologic, Inc.
Genius AI Detection
2.0 (K221449)

21 CFR 892.2090/
Radiological Computer Assisted
Detection and Diagnosis Software

A radiological computer assisted
detection and diagnostic software for
suspected lesions is an image
processing device intended to aid in
the detection, localization, and
characterization of lesions suspicious
for cancer on acquired medical images
(e.g., mammography, MR, CT,
ultrasound, radiography). The device
detects, identifies and characterizes
lesions suspicious for cancer based on
features or information extracted
from the images, and may provide
information about the presence,
location, and characteristics of the
lesion to the user. Primary diagnostic
and patient management decisions
are made by the clinical user.

Genius AI Detection 2.0 is a computer-
aided detection and diagnosis
(CADe/CADx) software device
intended to be used with compatible
digital breast tomosynthesis (DBT)
systems to identify and mark regions
of interest including soft tissue
densities (masses, architectural
distortions and asymmetries) and
calcifications in DBT exams from
compatible DBT systems and provide
confidence scores that offer
assessment for Certainty of Findings
and a Case Score. The device intends
to aid in the interpretation of digital
breast tomosynthesis exams in a
concurrent fashion, where the
interpreting physician confirms or


dismisses the findings during the
reading of the exam.

Envision Mammography Platform
Supports the following modes:
• High resolution 1-mm slices
(Clarity HD)
• High resolution 6-mm smart
slices (3DQuorum)

Hologic Selenia Dimensions
Hologic 3Dimensions
Supports both models in the
following modes:
• Standard
resolution 1-mm slices
• High resolution
1-mm slices (Clarity
HD)
• High resolution
6-mm smart slices
(3DQuorum)

The Envision
Mammography
Platform
supports High
resolution slices;
standard
resolution is not
available.

Radiological computer assisted
detection and diagnostic software

Image processing device utilizing
machine learning to aid in the
detection, localization, and
characterization of soft tissue
densities (masses, architectural
distortions and asymmetries) and
calcifications in the 1-mm 3D DBT
slices. Findings are co-registered to 6-
mm SmartSlices.

To inform the primary diagnostic and
patient management decisions that
are made by the clinical user.

Symptomatic and asymptomatic
women undergoing mammography.

MQSA- Qualified Interpreting
Physicians and Radiologists

Places mark within suspicious lesion
by default (Emphasize ™; RightOn™)


and reports confidence of finding next
to each identified lesion in the image.
CAD display may be toggled on/off.
Option to automatically zoom into or
contour the suspicious region of
interest (PeerView™).


Product Name
Rapid Neuro3D (Subject Device)
Rapid (including Rapid CTA) (K233582)

21 CFR 892.2050; Medical image
management and processing system

Intended
Use/
Indica'ons for
Use
Statement

Rapid is an image processing soOware
package to be used by trained professionals,
including but not limited to physicians
(medical analysis and decision making) and
medical technicians (administra've case
processing). The soOware runs on a standard
off-the-shelf computer or a virtual pla`orm,
such as VMware, and can be used to perform
image viewing, processing, and analysis of
images. Data and images are acquired
through DICOM compliant imaging devices.
Rapid is indicated for Adults only.
Rapid provides both viewing and analysis
capabili'es for func'onal and dynamic
imaging datasets acquired with CT, CT
Perfusion (CTP), CT Angiography (CTA), C-arm
CT Perfusion and MRI including a Diffusion

Angiography (CTA) from the aor'c arch to

the isolated leO and right internal caro'd

the physician in confirming the presence


or absence of physician-iden'fied lesions

Weighted MRI (DWI) Module and a Dynamic
Analysis Module (dynamic contrast-enhanced
imaging data for MRI, CT, and C-arm CT).
Rapid C-arm CT Perfusion can be used to
qualita'vely assess cerebral hemodynamics in
the angiography suite.
The CT analysis includes NCCT maps showing
areas of hypodense and hyperdense 'ssue.
The DWI Module is used to visualize local
water
diffusion proper'es from the analysis of
diffusion -weighted MRI data.
The Dynamic Analysis Module is used for
visualiza'on and analysis of dynamic imaging
data, showing proper'es of changes in
contrast over 'me. This func'onality includes
calcula'on of parameters related to 'ssue
flow (perfusion) and 'ssue blood volume.
Rapid CT Perfusion and Rapid MR Perfusion
can be used by physicians to aid in the
selec'on of acute stroke pa'ents (with
known occlusion of the intracranial internal
caro'd artery or proximal middle cerebral
artery).
Instruc'ons for the use of contrast agents for
this indica'on can be found in Appendix A of
the User’s Manual. Addi'onal informa'on for
safe and effec've drug use is available in the
product-specific iodinated CT and gadolinium-
based MR contrast drug labeling.
In addi'on to the Rapid imaging criteria,
pa'ents must meet the clinical requirements
for thrombectomy, as assessed by the
physician, and have none of the following
contraindica'ons or exclusions:
• Bolus Quality: absent or inadequate bolus.
• Pa'ent Mo'on: excessive mo'on leading to
ar'facts that make the scan technically
inadequate.

Its results are not intended to be used on

a stand-alone basis for clinical decision-

that meet the following module exclusion


• Presence of hemorrhage.
• C-Arm CTP is not used in the Rapid
Thrombectomy
indica'on for pa'ent selec'on criteria, other
modali'es should be consulted.
Cau'on
CBV and CBT are not absolute and CBT, CBV,
MTT and Tmax are supported for qualita've
interpreta'on of the perfusion maps only.

Medical imaging professionals who analyze
'ssue using CT or MRI images

interven'onal specialists, ED physicians,

SoOware package (SaMD) which interfaces to
a PACS/Viewer or allows viewing within the
applica'on.

Standard off-the-shelf Hardware: On-
Premises or Cloud Hybrid

Imaging Type
Neurological (aor'c arch to the vertex
Neurological

• 2D/3D vessel visualiza'on (Thins, MIPS,
VR, CPR)
• Automated segmenta'on and removal
of obstruc've bones and/or vessels

• Digital image processing, visualiza'on, and
analysis tools (various detailed in IFU above,
including 'ssue flow (perfusion), 'ssue blood
volume, etc.)
Specifically for Rapid CTA:
• 2D/3D vessel visualiza'on (MIPS, colored
overlay indica'ng reduc'on of vessel density)
• Automated segmenta'on and removal of
obstruc've bones and/or vessels


Manufacturer
Predicate Trade Name
Application No.
Product Code


Supported Imaging
Non-contrast CT (NCCT)
Non-contrast CT (NCCT)

Results of Image
Internal, no image marking
Internal, no image marking

Initial assessment, non-
diagnostic purposes

device, the previously cleared Viz ICH. Thus, JLK-ICH is substantially equivalent.


DICOM Information about the
patient, study and current
image.

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

Compatibility with the
DICOM Compatible
DICOM Compatible

Artificial intelligence algorithm
with database of images

No. Cases are not removed
from worklist or deprioritized.

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

Time to Notification
0.49±0.15 minutes
0.19 ±0.04 minutes


Performance Metrics Overview for Patients Categorized by Age


Performance Metrics Overview for Patients Categorized by Gender

Gender
N
Sensitivity [95% CI]
Specificity [95% CI]


Performance Metrics Overview for Patients Categorized by Race-Ethnicity

Race-Ethnicity
N
Sensitivity [95% CI]
Specificity [95% CI]


Performance Metrics Overview for Patients Categorized by Scanner Manufacturer

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


Performance Metrics Overview for Patients Categorized by Slice Thickness

Slice Thickness
N
Sensitivity
Specificity


Performance Metrics Overview for Patients Categorized by ICH Subtype

Intraparenchymal Hemorrhage (IPH)
36
1.0 [1.00, 1.00]

Intraventricular Hemorrhage (IVH)
12
0.92 [0.75, 1.00]

Subarachnoid Hemorrhage (SAH)
32
0.97 [0.91, 1.00]

Subdural Hemorrhage (SDH)
22
0.95 [0.86, 1.00]

Epidural Hemorrhage (EDH)
3
0.67 [0.00, 1.00]


Performance Metrics Overview for Patients Categorized by ICH Volume


NCCT-to-notification
Mean Estimate
95% Lower CI
95% Upper CI
Median


ITEM
Proposed Device: uAngio AVIVA CX
Predicate Device: Azurion R2.1(K200917)
Remark

Image-intensified fluoroscopic x-ray
system

Classification Regulation
21 CFR, Part 892.1650
21 CFR, Part 892.1650
Same

Classification Panel
Radiology
Radiology
Same

The system is used to perform image
guidance in diagnostic, intervention and
surgical procedures.
Procedures that can be performed with the
system include cardiac angiography,
neuro-angiography, vascular and non-
vascular angiography, rotational
angiography and whole body
radiographic/fluoroscopic procedures.

The Azurion series (within the limits of the
used operating room table) is intended for use
to perform:
• Image guidance in diagnostic, interventional,
and minimally invasive surgery procedures for
the following clinical application areas:
vascular, non-vascular, cardiovascular, and
neuro procedures.
•Cardiac imaging applications including
diagnostics, interventional and minimally
invasive surgery procedures.
Additionally:
•The Azurion series can be used in a hybrid
operating room.
•The Azurion series contains a number of
features to support a flexible and patient-centric


procedural workflow.
Patient Population:
All human patients of all ages. Patient weight is
limited to the specification of the patient table.

Max. current
1000 mA at 100 kV
1000 mA at 100 kV
Same

Focal spot
0.4mm, 0.6mm, 1.0mm
0.4mm, 0.7mm
Note2

Max. field of view
48 cm diagonal
48 cm diagonal
Same

longitudinal movement
Max. 6350 mm
Max. 6350 mm
Same


lateral movement range
Max. 2360 mm
Max. 2360 mm
Same

280 kg + 600 N for CPR
CPR can be done in any position of the
table top

250 kg + 500 N for CPR.
CPR can be done in any position of the table
top

Patient table - config.2 Multi-tilt table

max. patient weight
280 kg + 600 N for CPR
250 kg + 500 N for CPR.
Note8

Bolus Chase and Bolus
Chase Reconstruction


IEC 60601-1, 2nd Ed.
+ Amendment No. 1
+ Amendment No. 2 + Corrigendum


ITEM
Proposed Device: uAngio AVIVA CX
Reference Device: SmartCT R1.0(K201583)
Remark


In general, both products are used to perform image guidance in diagnostic, interventional, and surgery procedures, and

are suitable for all human patients of all ages. The description differences between the two products do not affect safety


uAngio AVIVA CX has one more focal spot than the predicate device. Even if one focal filament fails, the others remain

operational, and the drive circuits for all three focal filaments are independent. The difference does not introduce safety

The smaller the pixel pitch, 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.

The patient table (config.1 Floating table) of the proposed device has a higher weight capacity, meeting the needs of more

The patient table (config.1 Floating table) of the proposed device has a higher patient weight capacity, enabling it to serve

The patient table (config.1 Floating table) of the proposed device has a larger rotation range, meeting the needs of more

The patient table (config.2 Multi-tilt table) of the proposed device has a higher weight capacity, meeting the needs of

more clinical scenarios. The difference does not introduce safety and effectiveness issues.

The patient table (config.2 Multi-tilt table) of the proposed device has a higher patient weight capacity, enabling it to

serve a broader patient population. The difference does not introduce safety and effectiveness issues.

The patient table (config.2 Multi-tilt table) of the proposed device has a larger rotation range, meeting the needs of more

The patient table (config.2 Multi-tilt table) of the proposed device has a broader total tilt range than that of the predicate

device. The difference does not introduce safety and effectiveness issues.

uSpace uses multi-view cameras with machine learning methods and includes the following features:

1. uSpace Auto Positioning: it allows users to send a specific body part of the patient to the system and automatically

position it by long-pressing a button. 2. uSpace VeraCT: it allows users to skip the process of conventional AP and lateral

positioning and Test Run during the VeraCT acquisition, and get to the acquisition start point only by long-pressing one

button.3. uSpace Auto SID: adjust the SID within a certain range to make it closer to the patient's surface. 4. uSpace Auto

Parameter: reduce the process of parameters setting based on the patient's actual body thickness. 5. uSpace Iso Tracking:

adjust the table height to align the patient’s isocenter with the C-arm isocenter.

System motion is initiated only by the user's continuous triggering and the system is equipped with hardware-based

collision prevention features to ensure safety. The difference does not introduce safety and effectiveness issues.


uLingo is based on a machine learning method and it allows the system to be controlled via user's voice command, such

as protocol selection, image browsing, motion control, and tool utilization, to enhance the system's usability. uLingo will

not directly trigger radiation or motion. The system provides voice confirmation/feedback for the functions related to

radiation and motion, for example motion lock/unlock, radiation lock/unlock, protocol selection, motion control, etc. The

difference does not affect safety and effectiveness.


The bench tests evaluate the performance of CBCT.
The objectives of the tests are to demonstrate:
i. C-arm positioning accuracy;
ii. Imaging performance of CBCT (including in-plane uniformity,
spatial resolution, reconstruction section thickness, noise, contrast
to noise ratio, artifact analyses) can meet the requirements.
iii. Radiation dose can meet the requirements.
The geometric phantom, Catphan700 phantom, chest phantom,
head phantom, CTDI dosimetry phantom, body phantom and head
phantom are used in the tests above.
The test results show:


- The position error of the C-arm is acceptable and the position is
repeatable.
- The imaging performance of CBCT fulfills the requirements.
- CTDI of CBCT protocols fulfills the requirement.
Note: CBCT images are not for quantitative use.

The tests evaluate the performance of the Image Registration
Algorithm.
The objectives of the tests are to demonstrate:
- The accuracy of the Image Registration Algorithm can meet the
requirement of mean target registration error (mTRE) less than
the pixel diagonal distance.
The test results show:
- Using DSA mask to regist with DSA mask, CBCT, CT, CTA,
and MR for testing image registration. Each group has three sets
of test data.
- All the mTREs of the test cases are smaller than the voxel
diagonal distance, which can achieve sub-pixel accuracy
registration. Image Registration Algorithm is able to meet the
verification criteria, the verification result is passed.

The tests evaluate the performance of the DSA Algorithm.
The objectives of the tests are to demonstrate:
Dynamic range meets the submillimeter vessel simulation
component is visible across all copper step wedges of the
subtracted image.
Contrast sensitivity meets the low millimeter vascular simulation
component should be visible in a copper step wedge of sufficient
thickness in the subtraction image.
The test results show:
Using digital subtraction angiography phantom with
compensation test step wedge to test subtracted image of
DSA，four typical groups（Body，Head，Vascular，
Pediatric） are tested ,each group applying two sets of test data.
From the testing results, submillimeter sized blood vessels can be
seen in all copper step wedges, and the thickness of blood vessels
visible in sufficiently thick copper step wedges meets the
requirements.

The tests evaluate the performance of Neuro Registration
Algorithm.
The objectives of the tests are to demonstrate:
- The accuracy of neuro registration can meet a precision of at
least 1 mm.
The test results show:
- Using 3D DSA mask to register with an FL image for testing
neuro registration. It has eight sets of test data in the group.


- The registration results of neuro registration algorithm is that the
mTRE is less than 1mm. The neuro registration was able to meet
a precision of at least 1 mm, the verification was passed.

The tests evaluate the performance of the Stitching Algorithm.
The objectives of the tests are to demonstrate:
- The accuracy of the Image Registration Algorithm in Stitching
can meet the requirement of mean target registration error
(mTRE) less than the pixel diagonal distance.
- The stitching results meet the clinical needs, with an average
score from clinical specialists higher than 2.
The test results show:
- All the mTREs of the test cases are smaller than the pixel
diagonal distance, and the average score of stitching results is
2.95, which is higher than 2.The Stitching Algorithm was able to
meet the verification criteria and the verification of the algorithm
was passed.

The tests evaluate the performance of uSpace futures.
The objectives of the tests are to demonstrate:
- Test the performance of the human key point detection accuracy.
- Test the performance of the collision detection rate.
- The performance of the auto SID meets the distance
maintenance accuracy. And the adjustment of SID meets the
requirements of radiation safety and image quality.
The test results show:
- Human key point detection achieves the required accuracy for
not deviating from the range of the acquisition field of view.
- Collision detection achieves the specified detection rate.
- Auto SID adjustment achieves the required accuracy for
maintaining a distance from detector to the patient during C-arm
rotation or patient table lifting.
Primary protective barrier, Field limitation and Air kerma rates
were tested within the allowable adjustment range of the system.
The radiation safety test results of the uAngio AVIVA CX under
different SID.
The image quality evaluation was tested through the clinical
evaluation and objective physical characteristics. According to the
acceptable criteria in the regulations, the image quality test results
of the uAngio AVIVA CX under different SID meet the
requirements.

The tests evaluate the performance of the uLingo algorithm.
The objectives of the tests are to demonstrate:
- Test the performance of wake-up algorithm.
- Test the performance of voice commands recognition
algorithm.


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

The Rapid MLS software device is
designed to measure the midline
shift of the brain from a NCCT
acquisition and report the
measurements. Rapid MLS analyzes
cases using machine learning
algorithms to identify locations and
measurements of the expected brain
midline and any shift which may
have occurred. The Rapid MLS
device provides the user with
annotated images showing
measurements. Its results are not
intended to be used on a stand-alone
basis for clinical decision-making or
otherwise preclude clinical
assessment of NCCT cases.

Non-gated, CT Pulmonary
Angiography images

DICOM Compliance
Yes, using CTPA
Yes, using NCCT

Measurements
Heart RV, LV diameter
Brain midline measures

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


Type of Magnet
Superconducting
Superconducting
Same

1.40ppm @ 50cm DSV
0.90ppm @ 45cm DSV
0.45ppm @ 40cm DSV
0.190ppm @ 30cm DSV
0.120ppm @ 20cm DSV
0.040ppm @ 10cm DSV

Resonant frequencies
63.87 MHz
63.87 MHz
Same


Patient Table:
width 640 mm, height
880 mm, length 2620
mm

Detachable Table:
width 826 mm, height
880 mm, length 2578
mm

Detachable Table:
width 810 mm, height
880 mm, length 2505
mm

Wireless UIH Gating
Unit REF
453564324621
ECG module Ref
989803163121
SpO2 module Ref
989803163111(alternati
ve)


mmw100 (optional)
mmw100 (optional)
Same


Table 2 Comparison to Reference device#1


Table 3 Comparison to Reference device#2


Table 4 Comparison to Reference device#3


The intended use of Breast Coil - 12 is essentially identical to previously cleared
Breast Coil - 10. There are two differences between Breast Coil – 12 and Breast Coil –
10. One is that Breast Coil - 12 can be used with Biopsy Configuration to provide
breast biopsy function. The other one is the number of channels of the receiver coil.
The difference did not raise new safety and effectiveness concerns.

The intended use of Head Coil - 16 is equivalent to Head Coil – 12 previously cleared
via K200024. The only difference between them is the number of channels of the
receiver coil.
The difference did not raise new safety and effectiveness concerns.

The dimensions of detachable table were changed from width 826mm, height 880mm,
length 2578mm to width 810mm, height 880mm, length 2505mm.
The difference did not raise new safety and effectiveness concerns.

One alterative wireless VSM was removed from the proposed device.
The difference did not raise new safety and effectiveness concerns.

Inline ECV aims to calculate the pixel-wise ECV (extracellular volume fraction) images
from the native and post T1 mapping.
The difference did not raise new safety and effectiveness concerns.

Inline MOCO is a function that perform motion correction on MR images, which can
reduce the motion caused by physiological factors such as breathing and heart beat in
the images.
The difference did not raise new safety and effectiveness concerns.

MTP is substantially equivalent to GRE and acquires two flip angles and multi-echo
images with one scan, and then uses specific image processing to attain multi-
parametric images.
The difference did not raise new safety and effectiveness concerns.

TI Scout automatically selects the TI frame which has the darkest ventricular
myocardium of the TI Scout image, allowing users to achieve the best inversion time
(TI) and simplifying the workflow which needed the TI.
The difference did not raise new safety and effectiveness concerns.

Breast Biopsy is a workflow that can provide biopsy instruction for technicians based
on the hardware and lesion parameters, the instruction include the biopsy grid
coordinate, needle block cell and needle depth.
The difference did not raise new safety and effectiveness concerns.

Auto Bolus tracker is a feature that automatically recognizes the time when the contrast
agent reaches the target position and triggers the scan.
The difference did not raise new safety and effectiveness concerns.

EasyScan of the proposed device supports more body parts than that of the predicate
device. In this submission, breast and pelvis and hip and ankle and thorax are
included.
The difference did not raise new safety and effectiveness concerns.

SparkCo is an algorithm that can detect and correct spark artifacts (a specific occurring
MRI artifact that is caused by electromagnetic interference (EMI)) in MRI images.
The difference did not raise new safety and effectiveness concerns.


During this submission, inline ED/ES Phases Recognition was included in Inline
Cardiac function, which allows automatically rearrange the cardiac images into an
aligned cardiac cycle.
The difference did not raise new safety and effectiveness concerns.

Inline MRS of the proposed device are the same as the predicate device. The
difference is that the algorithms of Inline MRS are shifted from the post-processing
workstation to inline console.
The difference did not raise new safety and effectiveness concerns.

EasyCrop of the proposed device supports more body parts than that of the predicate
device. In this submission, head and carotid and renal are included.
The difference did not raise new safety and effectiveness concerns.

uVision of the reference device just supports Hand Gesture Recognition. During this
submission, Body Part Recognition function was included in uVision, which allows
assist patient positioning by performing image recognition on human natural images
through a 3D camera during the positioning stage.
The difference did not raise new safety and effectiveness concerns.


Table 5 Distribution of volunteer dataset


Evaluation Item
Evaluation Method
Criteria
Results

The performance of AI was
evaluated by comparing
the input error and output
error with respect of
NRMSE. If the NRMSE of
the AI output is less than
the NRMSE of input, the

The ratio of error:
NRMSE(output)/
NRMSE(input) is
always less than
1.

Table 6 The performance evaluation report criteria of ACS


performance of AI is
considered to be validated.

Calculating SNR for both
ACS and CS images under
the same acceleration
factors and protocol
parameters

Calculating the resolution
value in elliptic ROI using
the (standard deviation
(SD) / mean value(S)) for
both ACS and CS images
under the same
acceleration factors and
protocol parameters

ACS has higher
(standard
deviation (SD) /
mean value(S))
values than CS.

Comparing the ROI signal
intensities between images
acquired with fully
sampled and ACS images
under the same
acceleration factors with
different TI values

Bland-Altman
analysis of image
intensities
acquired using
fully sampled and
ACS was shown
with less than 1%
bias and all
sample points
falls in the 95%
confidence
interval.

Images of the phantom
were acquired with fully
sampled and ACS protocol
respectively. Method used
here for data analysis is
according to NEMA MS 6-
2008(R2004)

ACS achieved
significantly
same image
uniformities as
fully sampled
image

Dimensions of selected
small structures were
identified and measured on
ACS images as well as on
fully sampled images.

Measurements
differences on
ACS and fully
sampled images
of same structures
under 5% is
acceptable.


Table 7 The demographic distribution of real-world spark testing dataset


Test parts
Test Methods
Accept criteria
Test Results

Based on the real-world
testing dataset, calculating
the detection accuracy by
comparing the spark
detection results with the
ground-truth.

The average detection
accuracy need be larger
than 90%

Test on the
spark
correction
performance

Based on the simulated spark
testing dataset, calculating
the PSNR (Peak signal-to-
noise ratio) of the spark-
corrected images and original
spark images

The average PSNR of
spark-corrected images
need to be higher than
the spark images.
Spark artifacts need to
be reduced or corrected

The average PSNR of
spark-corrected images
is 1.6 higher than the
spark images.
The images with spark
artifacts were

Table 9 The test methods and test results of SparkCo


The error between the phase indices calculated
by the algorithm for the ED and ES of test data
and the gold standard phase indices.

The average error does not exceed 1 frame.

Table 10 Validation type and acceptance criteria


Table 11 Distribution of volunteer dataset


To verify the effectiveness of the algorithm, the subjective evaluation
method was used. The segmentation result of each case was obtained with
the algorithm, and the segmentation mask was evaluated with the following
criteria. The test pass criteria was: no failure cases, satisfaction rate
S/(S+A+F) exceeding 95%.
The criteria is as follows:
Satisfied (S): the segmentation myocardial boundary adheres to the

myocardial boundary and blood pool ROI is within the blood pool
excluding the papillary muscles.
Acceptable (A): These are small missing or redundant areas in the

myocardial segmentation but not obviously and the blood pool ROI is
within the blood pool excluding the papillary muscles.
Fail (F): The myocardial mask does not adhere to the myocardial

boundary or the blood pool ROI is not within the blood pool, or the
blood pool ROI contains papillary muscles.

Table 23 Validation type and acceptance criteria


Table 14 Distribution of Patient dataset


Table 15 Segmentation algorithm subgroup analysis


The average Dice coefficient of the left ventricular myocardium after
motion correction is greater than 0.87.

Table 16 Validation type and acceptance criteria


Table 17 Sample size information of testing data


Subgroup
Details of each subgroup
Number of cases

Table 18 Cardiac perfusion images subgroup information


Table 19 Sample size information of testing data


Subgroup
Details of each subgroup
Samples Number

Table 20 Cardiac dark blood images subgroup information


Age
Average Dice after motion correction

Gender
Average Dice after motion correction

Ethnicity
Average Dice after motion correction

BMI (kg/m(2))
Average Dice after motion correction

Magnetic field strength (T)
Average Dice after motion correction

Disease conditions
Average Dice after motion correction

Table 21 Cardiac perfusion images subgroup performance test


Table 22 Cardiac dark blood images subgroup performance test


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

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

Michelle Huettner
Regulatory Affairs Director
Tel: +1 901 558 8035
Email: michelle.huettner@gehealthcare.com

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

3DXR
3DXR, with CleaRecon DL option
21CFR 892.1650, Image-intensified fluoroscopic x-ray system
OWB
QIH
Class II

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

3DXR
GE Medical Systems SCS
K181403
21CFR 892.1650, Image-intensified fluoroscopic x-ray system
OWB
Class II

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


Specification
Predicate Device:
Proposed Device:

No limitations on the patient
population

Same, except for CleaRecon DL
option which is validated for adult
population only

No, streak artifacts reduction by
Iodine Streaks Reduction only

Yes, streak artifacts removal
powered by DL-based algorithm

No, 3D reconstruction of moving
object with the compensation of
the respiratory motion

Yes, 3D reconstruction of coronary
stent with the compensation of the
respiratory and cardiac motion

No, read multiple acquisition
system DICOM tags to identify
the clinical protocol

Yes, read acquisition system 3D
preset in Imaging Purposes DICOM
tag

Metal Artifact Reduction
Identical
Identical

Active Tracker Detection
Identical
Identical

Iodine Streaks Reduction
Identical
Identical

3D Volume Size selection
Identical
Identical

between the predicate device and the proposed device:


The feature is newly supported for Siemens CT scanners and the subject device

This feature is a modified form of a feature cleared within the primary and/or
secondary predicate devices

This feature is currently supported by other cleared Siemens CT systems or
cleared Siemens stand-alone software applications. This feature will be
supported for the subject device with software version SOMARIS/10 syngo CT
VB20 and is substantially equivalent compared to the cleared version of the
primary/secondary predicate device.

The feature is not supported by the subject device or by the primary and/or
secondary predicate device.


Respiratory Motion
Management -
Interfaces for
respiratory gating:
- Varian RGSC
- Anzai
- Open Interface
- Open Online
Interface

Respiratory Motion
Management –
Direct i4D

Respiratory Motion
Management -
DirectBreathhold

CT VB20 compared to the predicate devices.


FAST 3D Camera/
FAST Integrated
Workflow

myExam
Companion –
myExam
Compass/
myExam Cockpit


NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20

NAEOTOM Alpha S
SOMARIS/10 syngo S
CT VB10 C
(K233657) (

QuantaMax
direct conversion
with “Quantum
Technology”

QuantaMax S
direct conversion U
with “Quantum C
Technology”


70, 90, 100, 120,
140, 150
(150 kV only
available on the
smaller tube-
detector system (B
system) and only in
combination with
the additional Sn
filter, 0.7 mm)

70, 90, 100, 120, 7
140, 150 1
(150 kV only
available on the
smaller tube-
detector system (B
system) and only in
combination with
the additional Sn
filter, 0.7 mm)


Maximum
temporal
resolution in
ECG gated or
triggered
examination
(ms)

Vario 2.D
Vitus
Installation option
with extended
distance (Vitus)

V
Vario 2.D
V
Vitus
V
Installation option
with extended
distance (Vitus)


Tin Filter for both
tubes: 0.4 mm
additional Tin Filter
for the smaller
tube-detector
system (B-system)
only: 0.7 mm

Tin Filter for both C
tubes: 0.4 mm S
additional Tin Filter T
for the smaller tube-
detector system (B-
system) only: 0.7
mm

ombined Tin Filter /
plit Filter, and extra
in Filter

option for patient
positioning with
FAST 3D Camera
installation options:
• ceiling mounted

option for patient o
positioning with p
FAST 3D Camera 3
installation options: i
• ceiling mounted

ption for patient
ositioning with FAST
D Camera
nstallation options:
• ceiling mounted

Option to trigger O
hands-free scanning h

Option for
mounting of the
tablet on the
patient table.

Option for mounting O
of the tablet on the o
patient table. p

ption for mounting
f the tablet on the
atient table.

Option to move the
table during
myNeedle Guide
procedures in the
examination room.
electrical
connection for the
tablet dock which
allows charging the
tablet when
mounted.

Option to move the O
table during t
myNeedle Guide m
procedures in the p
examination room. e
electrical connection e
for the tablet dock f
which allows w
charging the tablet c
when mounted. w

ption to move the
able during
yNeedle Guide
rocedures in the
xamination room.
lectrical connection
or the tablet dock
hich allows
harging the tablet
hen mounted.


NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20

NAEOTOM Alpha S
SOMARIS/10 syngo S
CT VB10 C
(K233657) (K

respiratory gating
systems
• Open Online
Interface


NAEOTOM Alpha
SOMARIS/10 syngo CT
VB10
(K233657)

QuantaMax
Direct Conversion with
“Quantum Technology”

70, 90, 100, 120, 140,
150
(150 kV only available
on the smaller tube-
detector system (B
system) and only in
combination with the


1200 (for 105 kW
Generator)
1300 (for 120 kW
Generator)


Maximum
temporal
resolution in ECG
gated or triggered
examination (ms)

Maximum scan
345 mm/s at pitch 1.5
737 mm/s at pitch 3.2
261 mm/s at pitch 1.7

Vario 2.D
Vitus
Installation option with
extended distance
(Vitus)

Vario RT: 1680
Vario 2.D: 2080
Vitus: 2080

Vario RT: 1600
Vario 2.D: 2000
Vitus: 2000

Vario RT: 227
Vario 2.D: 307
Vitus: 307 or 340

Tin Filter for both tubes:
0.4 mm
additional Tin Filter for
the smaller tube-detector
system (B-system) only:
0.7 mm

Combined Tin Filter / Split
Filter, and extra
Tin Filter


NAEOTOM Alpha
NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20

NAEOTOM
Alpha.Prime
SOMARIS/10 syngo
CT VB20

NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) (

SOMARIS/10 syngo
SOMARIS/10 syngo
CT VB10

Support of:
• Protocol
supporting
contrast bolus-
triggered data
acquisition
• Contrast media
protocols
(including
coronary CTA)
• Pediatric
Protocols
• Flex Dose Profile
• Turbo Flash
Spiral
• Dual Energy
acquisition
• Protocols
supporting CT
Intervention,
Cardiac
Scanning,
Spectral imaging
for child
examination,
Spectral imaging
with high
resolution
• Protocols for
Quantum
Imaging modes:
- Quantum
- Quantump
lus
- Quantum
HD
- Quantum
HD Cardiac
- Quantump
eak
• Dynamic
imaging (Flex 4D

Support of:
• Protocol
supporting
contrast bolus-
triggered data
acquisition
• Contrast media
protocols
(including
coronary CTA)
• Pediatric
Protocols
• Flex Dose Profile
• Turbo Flash
Spiral
• Dual Energy
acquisition
• Protocols
supporting CT
Intervention,
Cardiac
Scanning,
Spectral imaging
for child
examination,
Spectral imaging
with high
resolution
• Protocols for
Quantum
Imaging modes:
- Quantum
- Quantump
lus
- Quantum
HD
- Quantum
HD Cardiac
• Dynamic
imaging (Flex 4D

Support of:
• Protocol
supporting
contrast bolus-
triggered data
acquisition
• Contrast media
protocols
(including
coronary CTA)
• Pediatric
Protocols
• Flex Dose Profile
• Turbo Flash
Spiral
• Dual Energy
acquisition
(TwinBeam DE
and TwinSpiral
DE)
• Protocols
supporting CT
Intervention,
Cardiac
Scanning


Spiral with
separation
factor driven
scan range)
• Protocols for
Radiation
Therapy
Planning
support patient
marking
• Protocols for
DirectBreathhol
d
• Protocols for
FAST 4D
• Protocols that
allow scanning
with support of
an external
respiratory
gating system
(Anzai, Varian
RGSC, Open
interface, Open
Online
Interface)

• Dynamic
imaging (Flex 4D
Spiral Flex 4D
Spiral with cycle
time driven scan
range)
• Protocols for
Radiation
Therapy
Planning
support patient
marking
• Protocols for
DirectBreathhol
d
• Protocols for
FAST 4D
• Protocols that
allow scanning
with support of
an external
respiratory
gating system
(ANZAI, Varian
RGSC, Open
interface)

Recon&GO:
- Spectral Recon
- Inline Results – DE
SPP
- Inline Results –
Anatomical ranges
(Parallel/Radial)
incl. Virtual
Unenhanced,
Monoenergetic plus
- Inline Results –
Spine and Rib
Ranges

Recon&GO:
- Spectral Recon -
- Inline Results – DE -
SPP
- Inline Results – -
Anatomical ranges
(Parallel/Radial) (
incl. Virtual i
Unenhanced,
Monoenergetic plus
- Inline Results – -
Spine and Rib
Ranges

Recon&GO:
Spectral Recon
Inline Results – DE
SPP
Inline Results –
Anatomical ranges
Parallel/Radial)
ncl. Virtual
Unenhanced,
Monoenergetic plus
Inline Results –
Spine and Rib
Ranges


NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657)

- Inline Results –
table and bone
removal

CT View&GO:
- basic post-
processing viewer
(CT View&GO)
- 2D and 3D (MPR,
VRT, MIP and
minIP)
- Evaluation tools,
Filming, Printing
- Interactive
Spectral Imaging
(ISI)
- Basic visualization
tools: Endo View
- Basic
manipulation tools:
DE ROI, ROI HU
Threshold, Average
- Automated table
and bone removal

• Recon&GO
Inline Results:
Software interface
to post-processing
algorithms which
are unmodified
when loaded onto
the CT scanners and
510(k) cleared as
medical devices,
Inline Results – RT-
Planning introduced

• Recon&GO
Inline Results:
Software interface
to post-processing
algorithms which
are unmodified
when loaded onto
the CT scanners and
510(k) cleared as
medical devices
i
i

• Recon&GO
Inline Results:
Software interface
to post-processing
algorithms which
are unmodified
when loaded onto
the CT scanners and
510(k) cleared as
medical devices,
ncluding the
nterface Inline
Results – RT-
Planning


NAEOTOM Alpha
NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20

NAEOTOM
Alpha.Prime
SOMARIS/10 syngo
CT VB20

NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) (

SOMARIS/10 syngo
SOMARIS/10 syngo
CT VB10

• CT View&GO
plug-in
interface:
designed for
standalone plug-ins
which are
represented by the
cleared medical
device by its own
called syngo.CT
Extended
Functionality,
plug-in CT
View&GO –
Sim&GO introduced
• CT View&GO
software
interface for
Advanced
Visualization
Apps:
Software interfaces
for post-processing
functionalities to
provide advanced
visualization tools
to prepare and
process medical
images for
diagnostic purpose.
Note: The clearance
of standalone
Advanced
Visualization
Application
software is
mandatory
precondition.

• CT View&GO
plug-in
interface:
designed for
standalone plug-ins
which are
represented by the r
cleared medical
device by its own
called syngo.CT
Extended
Functionality
i
i
• CT View&GO
software
interface for
Advanced
Visualization
Apps:
Software interfaces
for post-processing f
functionalities to f
provide advanced
visualization tools
to prepare and t
process medical
images for i
diagnostic purpose.
Note: The clearance
of standalone
Advanced
Visualization
Application
software is
mandatory
precondition.
These advanced
visualization tools

• CT View&GO
plug-in
interface:
designed for
standalone plug-ins
which are
epresented by the
cleared medical
device by its own
called syngo.CT
Extended
Functionality,
ncluding the plug-
n CT View&GO –
Sim&GO
• CT View&GO
software
interface for
Advanced
Visualization
Apps:
Software interfaces
or post-processing
unctionalities to
provide advanced
visualization tools
o prepare and
process medical
mages for
diagnostic purpose.
Note: The clearance
of standalone
Advanced
Visualization
Application
software is
mandatory
precondition.
These advanced
visualization tools


Bench Testing performed for new and modified features

The target of the bench test is to perform a respiratory sequence scan
using a dynamic phantom where at every planned position of the scan
range at least one complete breathing cycle is acquired.
Objective of the test is to compare a conventional respiratory 4DCT scan
(spiral scan) with the breathing pattern of a thorax phantom and the
result of Direct i4D with the same breathing pattern.
The test results show that with Direct i4D it is possible to acquire data for
a full breathing cycle at every position of the patient even if the
respiratory rate changes during the data acquisition. Compared to the
conventional 4DCT scan mode interpolation artifacts (which occur
because not for every position a complete breathing cycle could be
acquired) can successfully be avoided with Direct i4D.

The test results show that using the Direct Breathhold functionality, a
spiral scan can automatically be triggered from an external respiratory
gating device. The actual scan remains unchanged, and the object is
correctly depicted in the resulting image.

The bench test underpins the possibility that with the introduction of the
RTP scan protocols in the subject devices NAEOTOM CT scanner systems
with syngo CT VB20, time and imaging dose can be saved, since each RTP
scan range allows for spectral post-processing to provide task-specific
images for an end-to-end radiotherapy workflow and thus no additional
scan range with Single Energy is needed.

Table 6: Non-clinical performance testing (bench testing).


FAST 3D Camera/
FAST Integrated
Workflow

The FAST 3D camera sub-features FAST Isocentering, FAST Range, and
FAST Direction have been optimized using additional data from adults
and adolescence patients. The bench test evaluates and compares the
accuracy of the three sub-features in software version syngo CT VB20 to
the accuracy of the predicate devices with syngo CT VB10.
The objectives of the bench tests are to demonstrate that the FAST 3D
camera achieves comparable or better results for both, adults and
adolescents, as the predicate device for adults.
Overall, the subject devices with syngo CT VB20 delivers comparable or
improved accuracy to the predicate devices with syngo CT VB10
predicate device for adults and extends the support to adolescents.

The performed bench test report describes the technical background of
Flex 4D Spiral and its functionalities with NAEOTOM CT scanners,
demonstrate the proper function of those, and assess the image quality
of Flex 4D Spiral.

The purpose of the test is to provide a clear reporting on the applied
algorithm, its product development, validation, and verification on
patient data, which enable the claims.
Objective of the test is to assess the fraction (percentage) of ranges
calculated by the FAST Planning algorithm that are correct and can be
applied without change. Additionally, calculation time was measured to
check whether it meets interactive requirements.
The test results show that the editing actions for the scanner technician
can be reduced to a minimum and that the calculation time is fast
enough for interactive speed during scanning. For more than 90% of the
ranges no editing action was necessary to cover standard ranges. For
more than 95%, the speed of the algorithm was sufficient.

Low-Dose Lung Cancer
Screening –
NAEOTOM Alpha.Pro

The bench test provides a comparison of technical parameters specific to
Low-Dose Lung Cancer Screening of the predicate and subject devices,
following the established concept of our previous 510(k) submissions.
It can be concluded that the subject and predicate devices are
substantially equivalent for the task of Low-Dose Lung Cancer Screening
since the bench test results showed comparable technical parameters.

Low-Dose Lung Cancer
Screening –
NAEOTOM
Alpha.Prime


Digital Imaging and
Communications in
Medicine (DICOM) Set

Supplemental
Requirements for User
Information and
System Function
Related to Dose in CT

Evaluation and routine
testing in medical
imaging departments -
Part 3-5: Acceptance
tests and constancy
tests - Imaging
performance of
computed tomography
X-ray equipment
[Including: Technical
Corrigendum 1 (2006)]

Evaluation and routine
testing in medical
imaging departments -
Part 2-6: Constancy
tests - Imaging
performance of
computed tomography
X-ray equipment

Medical electrical
equipment - Part 1-3:
General requirements
for basic safety and
essential performance
– Collateral Standard:
Radiation protection in
diagnostic X-ray
equipment

Table 7: Recognized Consensus Standards.


Medical electrical
equipment - Part 2-44:
Particular
requirements for the
basic safety and
essential performance
of x-ray equipment for
computed tomography

Medical devices -
Applications of risk
management to
medical devices

Medical devices -
Application of risk
management to
medical devices

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

62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION

Medical electrical
equipment - Part 1:
General requirements
for basic safety and
essential performance
(IEC 60601-1:2005,
MOD) [Including
Amendment 2 (2021)]

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


60601-1-2 Edition 4.1
2020-09
CONSOLIDATED
VERSION

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

62366-1 Edition 1.1
2020-06
CONSOLIDATED
VERSION

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

Safety of laser
products - Part 1:
Equipment
classification, and
requirements

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 2-28:
Particular
requirements for the
basic safety and
essential performance
of X-ray tube
assemblies for medical
diagnosis

Medical electrical
equipment - Medical
image display systems


Medical electrical
equipment - part 1:
general requirements
for basic safety and
essential performance

Conformity Assessment
– Supplier’s declaration
of conformity – Part 1:
General requirements

Declaration of
conformance to FDA
recognized consensus
standards.

Conformity assessment
– Supplier’s declaration
of conformity – Part 2:
Supporting
documentation.

General consensus
standards not currently
recognized by FDA.

Table 8: General Use Consensus Standards.


User Fees and Refunds for Premarket Notification Submissions (510(k)s

Electronic Submission Template for Medical Device 510(k) Submissions

Deciding When to Submit a 510(k) for a Change to an Existing Device

The 510(k) Program: Evaluating Substantial Equivalence in Premarket
Notifications [510(k)]

Content of Premarket Submissions for Device Software Functions

Off-The-Shelf Software Use in Medical Devices

Applying Human Factors and Usability Engineering to Medical Devices

Pediatric Information for X-ray Imaging Device Premarket Notifications

Table 9: FDA Guidance Document and Effective Date


Cybersecurity in Medical Devices: Quality System Considerations and Content 0
of Premarket Submissions

Electromagnetic Compatibility (EMC) of Medical Devices 0

Design Considerations and Pre-market Submission Recommendations for 0
Interoperable Medical Devices

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 0
for Medical Devices


The uMR Ultra system is indicated
for use as a magnetic resonance
diagnostic device (MRDD) that
produces sagittal, transverse,
coronal, and oblique cross sectional
images, and spectroscopic images,
and that display internal anatomical
structure and/or function of the
head, body and extremities.
These images and the physical
parameters derived from the images
when interpreted by a trained
physician yield information that
may assist the diagnosis. Contrast
agents may be used depending on
the region of interest of the scan.

The uMR Omega system is indicated
for use as a magnetic resonance
diagnostic device (MRDD) that
produces sagittal, transverse, coronal,
and oblique cross sectional images,
and spectroscopic images, and that
display internal anatomical structure
and/or function of the head, body and
extremities.
These images and the physical
parameters derived from the images
when interpreted by a trained
physician yield information that may
assist the diagnosis. Contrast agents
may be used depending on the region
of interest of the scan.

Table 1 Comparison of Indication for Use to Predicate device


Type of Magnet
Superconducting
Superconducting
Same

≤ 2.30 ppm @ 50cm DSV
≤ 0.80 ppm @ 45cm DSV
≤ 0.38 ppm @ 40cm DSV
≤ 0.08 ppm @ 30cm DSV
≤ 0.02 ppm @ 20cm DSV
≤ 0.002 ppm @ 10cm DSV


Max gradient amplitude
100 mT/m
45 mT/m
Note 2

Resonant frequencies
128.23 MHz
128.23 MHz
Same


Shanghai United Imaging Health
care Co., Ltd.

ECG, Respiration and pulse
ECG, Respiration and pulse

Shanghai United Imaging Healthcare Co., Ltd.


Electrical Safety
Comply with ES 60601-1
Comply with ES 60601-1
Same

EMC
Comply with IEC 60601-1-2
Comply with IEC 60601-1-2
Same

Comply with ISO 10993-5
and ISO 10993-10

Surface Heating
NEMA MS 14
NEMA MS 14
Same


N
ote 1 The patient-acc
essible bore dimension of the p
roposed device is smaller than t
hat of the


The max gradient amplitude of the proposed device is larger than that of the predicate
device. Peripheral nerve stimulation and cardiac stimulation was controlled according to
IEC 60601-2-33.
The difference did not raise new safety and effectiveness concerns.

The amplifier peak power per channel of the proposed device is the same as one
configuration of the predicate device.
The difference did not raise new safety and effectiveness concerns.

The number of receive channels of the proposed device is more than that of the predicate
device.
The difference did not raise new safety and effectiveness concerns.

The intended use of UHD SuperFlex Large - 24 is equivalent to previously cleared
SuperFlex SuperFlex Large - 12. The only difference between them is the number of
channels of the receiver coil.
The difference did not raise new safety and effectiveness concerns.

The intended use of UHD SuperFlex Small - 24 is equivalent to previously cleared
SuperFlex SuperFlex Small - 12. The only difference between them is the number of
channels of the receiver coil.
The difference did not raise new safety and effectiveness concerns.

The intended use of SuperFlex Whole Body - 48 is equivalent to previously cleared
SuperFlex Body - 24. The only difference between them is the number of channels of the
receiver coil.
The difference did not raise new safety and effectiveness concerns.

The intended use of UHD SuperFlex Free - 24 is identical to previously cleared Head &
Neck Coil - 48 (except imaging of head). The difference between them is the number of
channels of the receiver coil.
The difference did not raise new safety and effectiveness concerns.

The intended use of Wrist Coil - 24 is equivalent to previously cleared Wrist Coil - 12. The
only difference between them is the number of channels of the receiver coil.
The difference did not raise new safety and effectiveness concerns.

The intended use of Shoulder Coil - 24 is equivalent to previously cleared Shoulder Coil -
12. The only difference between them is the number of channels of the receiver coil.
The difference did not raise new safety and effectiveness concerns.

Compared to the predicate device, the proposed device added Tilt Support, which is used
to support Head & Neck Coil scanning.
The new component did not raise new safety and effectiveness concerns.

Compared to the predicate device, the proposed device added Positioning Couch-top.
Positioning Couch-top has load-bearing and deformation requirements. It is determined
according to clinical needs and product characteristics.
The new component did not raise new safety and effectiveness concerns.

Compared to the predicate device, the proposed device added Coil Support. Coil Support
can achieve the purpose of being as close as possible but not in contact with the human
body through the adjustment mechanism. The internal space and adjustment range can
adapt to different body types of people.
The new component did not raise new safety and effectiveness concerns.

Compared to the predicate device, the proposed device added Patient Bore Projector, which
projects the video into the bore for patients to watch during scanning to improve patient
comfort.
The new function did not raise new safety and effectiveness concerns.


Compared to the predicate device, the proposed device added Body Part Recognization
function in uVision, which allows assist patient positioning by performing image
recognition on human natural images through a 3D camera during the positioning stage.
The new function did not raise new safety and effectiveness concerns.

MQD is substantially equivalent to GRE without RF Spoiling and use varyling flip angle
and/or repetition time to acquire T1 mapping and T2 mapping images.
The new function did not raise new safety and effectiveness concerns.

EasyBolus is a workflow feature that combines the EasyScan function and the
AutoBolusTracer function, capable of automatically locating the Bolus protocol and its
ROI (Region of Interest), and observing changes in signal values within the ROI to
automatically trigger the next protocol. The positioning can also be adjusted manually by
user. If the user is not satisfied with the timing of the trigger, manual triggering is also
possible. The user panel also supports user configuration for manual triggering.
The new function did not raise new safety and effectiveness concerns.

Auto Bolus Tracker is a feature that automatically recognizes the time when the contrast
agent reaches the target position and triggers the scan.
The new function did not raise new safety and effectiveness concerns.

Inline CEST aims to calculate the images of Z-spectrum curve and MTRasym curve from
the data in ROI from S0, Ssat and B0Map.
The new function did not raise new safety and effectiveness concerns.

t-ACS (temporal AI-assisted Compressed Sensing) is a dynamic magnetic resonance
imaging technique which combines traditional Compressed Sensing algorithm with deep
learning priors. It outputs multi-phase images.
The new function did not raise new safety and effectiveness concerns.

AiCo (AI-based Motion Correction) is a k-space based technique to suppress motion
artifacts. After enabling the AiCo function, the original images will still be saved.
The new function did not raise new safety and effectiveness concerns.

EasyRegister is a function that automatic estimates patient’s height and weight and patient
position by performing regression on human natural images through a 3D camera during
the positioning stage. Based on the captured feature and estimated pose of the patient on
the table.
The new function did not raise new safety and effectiveness concerns.


Table 2 Comparison to reference device#1


In this submission, inline ED/ES phase recognition was included in the inline cardiac
function module.
Cardiac MR cine imaging captures multi-slice data with varying end-systolic (ES) and
end-diastolic (ED) phases in the absence of triggering signals (e.g., ECG). The inline
ED/ES recognition algorithm automatically identifies these phases per slice, enabling
cross-slice cardiac cycle alignment for functional analysis.
The difference did not raise new safety and effectiveness concerns.


Table 3 Comparison to reference device#2


Evaluation Item
Evaluation Method
Criteria
Results

The performance of AI was
evaluated by comparing the
input error and output error
with respect of NRMSE. If
the NRMSE of the AI
output is less than the
NRMSE of input, the

The ratio of error:
NRMSE(output)/
NRMSE(input) is
always less than
1.

corresponding testing results can be found in the table below.


performance of AI is
considered to be validated.

Calculating SNR for both
ACS and CS images under
the same acceleration
factors and protocol
parameters

Calculating the resolution
value in elliptic ROI within
a line-pair test object using
the (standard deviation
(SD) / mean value(S)) for
both ACS and CS images
under the same
acceleration factors and
protocol parameters

ACS has higher
(standard
deviation (SD) /
mean value(S))
values than CS.

Comparing the ROI signal
intensities between images
acquired with fully
sampled and ACS images
under the same
acceleration factors with
different TI values

Bland-Altman
analysis of image
intensities
acquired using
fully sampled and
ACS was shown
with less than 1%
bias and all
sample points
falls in the 95%
confidence
interval.

Images of the phantom
were acquired with fully
sampled and ACS protocol
respectively. Method used
here for data analysis is
according to NEMA MS 6-
2008(R2004)

ACS achieved
significantly same
image
uniformities as
fully sampled
image

Dimensions of selected
small structures were
identified and measured on
ACS images as well as on
fully sampled images.

Measurements
differences on
ACS and fully
sampled images
of same structures
under 5% is
acceptable.


DeepRecon images achieve higher SNR
compared to NADR images

Uniformity difference between
DeepRecon images and NADR images
under 5%

Intensity difference between DeepRecon
images and NADR images under 5%

Measurements on NADR and DeepRecon
images of same structures, measurement
difference under 5%

testing and the corresponding testing results can be found in the table below.


various genders, age groups, ethnicities and BMI groups as shown in the tables below.


Body part /Phantom
Dynamic MRI scan applications
Number of cases

Type I: Non-periodic physiological movement

CARDIAC
Type II: Cardiac periodic movement
25


Type I: Non-periodic physiological movement

ABDOMEN
Type III: Contrast enhancement
186

PELVIS
Type III: Contrast enhancement
52


with and without fat saturation. The demographic distribution was listed in table below.


Test parts
Test Methods
Accept criteria
Test Results

Based on the real-world
testing dataset, calculating
the detection accuracy by
comparing the spark
detection results with the
ground-truth.

The average detection
accuracy need be larger
than 90%

and spark correction effectiveness, as the following Table 6 shows.


Satisfied and Acceptable ratio (S+A)/(S+A+F) exceeds 95%.
Satisfied (S): Five ROIs are placed within the liver parenchyma, avoiding the
liver borders and vascular structures.
Acceptable (A): Fewer than five ROIs are placed within the liver
parenchyma, avoiding the liver borders and vascular structures.
Failure (F): ROIs are positioned on liver borders or vascular structures, or no
ROIs are placed.

The validation type and acceptance criteria is shown in the table below.


total of 25 cases from 25 volunteers were used.


Gender
Satisfied (S)
Acceptable (A)
Failure (F)
Satisfied and Acceptable Ratio


Error between TI frame output
by algorithm and gold
standard

The average frame difference between the frame of auto-calculated
TI and the gold standard frame is less than or equal to 1 frame, and
the maximum frame difference is less than or equal to 2 frames.


Scout algorithm performs as expected in different subgroups.


The average Dice coefficient of the left ventricular myocardium after
motion correction is greater than 0.87.


Subgroup
Details of each subgroup
Number of cases


Age
Average Dice after motion correction

Gender
Average Dice after motion correction

Ethnicity
Average Dice after motion correction

BMI (kg/m(2))
Average Dice after motion correction

Magnetic field strength (T)
Average Dice after motion correction

Disease conditions
Average Dice after motion correction


The error between the phase indices calculated
by the algorithm for the ED and ES of test data
and the gold standard phase indices.

The average error does not exceed 1 frame.


table below. A total of 95 cases from 56 volunteers were used.


good generalization in different subgroups.


To verify the effectiveness of the algorithm, the subjective evaluation
method was used. The segmentation result of each case was obtained with
the algorithm, and the segmentation mask was evaluated with the following
criteria. The test pass criteria was: no failure cases, satisfaction rate
S/(S+A+F) exceeding 95%.
The criteria are as follows:
Satisfied (S): the segmentation myocardial boundary adheres to the

myocardial boundary and blood pool ROI is within the blood pool
excluding the papillary muscles.
Acceptable (A): These are small missing or redundant areas in the

myocardial segmentation but not obviously and the blood pool ROI is
within the blood pool excluding the papillary muscles.
Fail (F): The myocardial mask does not adhere to the myocardial

boundary or the blood pool ROI is not within the blood pool, or the
blood pool ROI contains papillary muscles.


segmentation algorithm performs as expected in different subgroups.


The performance of the height estimation algorithm is shown in the table below.


The EasyBolus has undergone performance testing on 20 subjects


Exclusion ● CT images with or without ● Chest CT with or without contrast


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

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


Table 6. Frequency Distribution of slice thickness


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


Manufacturer
Predicate Trade Name
Application No.
Product Code


Intended User
Radiologist
Neurovascular Specialist

Indicated Imaging
Non-contrast CT (NCCT)
Non-contrast CT (NCCT)

Diagnostic Application
Notification-only
Notification-only

Artificial Intelligence / Machine
Learning.

Results of Image
Internal, no image marking
Internal, no image marking

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

Relationship to standard
In Parallel / Concurrently
In Parallel / Concurrently

Compatibility with the
DICOM Compatible
DICOM Compatible

Artificial intelligence algorithm
with database of images

Initial assessment; non-
diagnostic purposes
Presentation of preview of the
study for initial informational
purposes

No. Cases are not removed
from worklist or deprioritized.

Acquires medical image data
from DICOM compliant imaging
devices and modalities

Time to Notification
0.19 ±0.05 minutes
1.15±0.57 minutes


Performance Metrics Overview for Patients Categorized by States (i.e. Clinical Site)

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


Performance Metrics Overview for Patients Categorized by Age

Region 002: Northeast – New York / Midwest – Missouri, Iowa, Wisconsin, Illinois, Ohio


Performance Metrics Overview for Patients Categorized by Gender

Gender
N
Sensitivity [95% CI]
Specificity [95% CI]


Performance Metrics Overview for Patients Categorized by Race-Ethnicity

Race-Ethnicity
N
Sensitivity [95% CI]
Specificity [95% CI]


Performance Metrics Overview for Patients Categorized by Scanner Manufacturer

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


Performance Metrics Overview for Patients Categorized by SDH Type


Performance Metrics Overview for Patients Categorized by SDH with Other Hemorrhage

SDH and other Hemorrhage
N
Sensitivity [95% CI]

Subdural Hemorrhage Only
95
0.99 [0.97, 1.00]

Subdural Hemorrhage and Other
Hemorrhage Present


Performance Metrics Overview for Patients Categorized by SDH Location


Performance Metrics Overview for Patients Categorized by Slice Thickness

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


Performance Metrics Overview for Patients Categorized by SDH Thickness


Performance Metrics Overview for Patients Categorized by SDH Volume


Performance Metrics Overview for Patients Categorized by Metal Artifacts

Metallic artifact
N
Sensitivity [95% CI]
Specificity [95% CI]


Sonio
147 Rue d’Aboukir,
75002, Paris France

Florian Akpakpa
Director Regulatory Affairs and Quality Assurance
Sonio
Phone: +33 6 19 38 71 45
Email: florian.akpakpa@sonio.ai


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


Absence or unusual size of at least one of the 3
vessels

Malposition of the great vessels
LVOT/RVOT
T2/T3

Disequilibrium OR absence of at least one of the
two ventricles

Non-visibility of a single stomach bubble OR
abnormally big stomach

Cephalic
Absence of the cavum septum pellucidum
Transthalamic view
T2/T3


Yes
It is an image reconstruction method
for cardiac scanning based on deep
learning technology.

Yes
It is an image reconstruction method
that combines a modal-based iterative
reconstruction and deep learning
technology.

Yes
It can recommend the optimal phase
for cardiac reconstruction, which is
based on deep learning technology.

Yes
It is an intelligent function based
on deep learning to reduce the
artifacts caused by head motion.

Yes
It can extend reconstruction FOV to
bore size using deep learning
technique.

Yes
It is a motion correction function for
cardiac scanning to reduce coronary
motion artifact, which is based on
deep learning technology.
Only uCT ATLAS Optimize this
function

Yes
Both uCT
ATLAS and
uCT ATLAS
Astound have
this function


Compared to the reference device (K230162), CardioBoost in subject devices is an
image reconstruction method for cardiac. The difference in the subject devices is datasets
augmentation and deep learning network optimization in order to improve the overall
performance for cardiac images reconstruction
From the user perspective, the workflow remains the same between the subject device
and reference device.


For uCT ATLAS:
Compared to the predicate device (K231482), the differences in the subject device are
datasets augmentation and deep learning network optimization to enable reconstruction
for head.
For uCT ATLAS Astound:
Compared to the predicate device (K231482), the difference in the subject device is deep
learning network optimization to improve the overall performance.
From the user perspective, the workflow remains the same between the subject devices
and predicate devices.

Compared to the predicate devices (K231482), the difference in the subject device is the
introduction of a new deep learning based coronaries detection algorithm to improve the
performance of CardioXphase. The functionality to select the best phase flowchart
already exists in the predicate devices CardioXphase (K231482).
From the user perspective, the workflow remains the same between the subject devices
and reference devices

The function of Motion Freeze is an image reconstruction algorithm which intend to
correct the patient head motion, this will not raise new safety and effectiveness concerns.

Compared to the predicate devices (K231482), the difference in the subject devices is
that Ultra EFOV introduces a deep learning network to improve HU accuracy in the area
of extended FOV.
From the user perspective, the workflow remains the same between the subject devices
and reference devices.

CardioCapture in this submission is only optimized for uCT ATLAS.
Compared to the predicate device(K231482), the difference in the subject device is the
introduction of the deep learning module.
From the user perspective, the workflow remains the same between the subject device
and predicate device. .


The bench test for CardioBoost was performed to evaluate the

·General IQ Performance testing of metrics identified in IEC

61223-3-5 to study overall performance in a standardized and

referenceable manner. General IQ tests include CT HU number

·A low contrast detectability (LCD) test was performed under

the guidance of CTIQ White Paper to evaluate the LCD

enhancement, dose reduction and noise reduction.

·A high contrast spatial resolution test was performed under

·CardioBoost passed the basic general IQ test which satisfied

·CardioBoost showed better LCD comparing with FBP at

same scanning dose and can reduce scanning dose comparing

·CardioBoost showed better noise comparing with FBP.

·CardioBoost showed better spatial resolution comparing with

The bench test for AIIR was performed to evaluate the subject

·AIIR passed the basic general IQ test which satisfied the

·AIIR showed better LCD comparing with FBP at same

scanning dose and can reduce scanning dose comparing with


·AIIR showed better noise comparing with FBP.

·AIIR showed better spatial resolution comparing with FBP at

The bench test for CardioXphase was performed to evaluate the

extraction accuracy of new AI module in heart and coronary

artery structure. Other modules are same as the function cleared

The quantitative assessment metrics for the heart mask and

coronary artery mask extracted by the new AI module and the

annotated results are calculated: Dice Similarity Coefficient

The test results show that all indicators have met the

verification criteria and have passed the verification.

The bench test for Motion Freeze was performed to evaluate the

effectiveness on reducing head motion artifacts, by comparing

the artifacts on images with- and without- Motion Freeze,

The test results show that Motion Freeze can reduce head

The bench test for Ultra EFOV was performed to evaluate the

effectiveness on improving CT value accuracy, by comparing

the CT value of images with EFOV and the CT value of

The test results show that Ultra EFOV can improve the CT

number, in cases where the scanned object exceeds the CT field


The clinical images reconstructed with CardioBoost and KARL
3D respectively were shown to the readers to perform a five-
point scale evaluation of both image sets on the several image
quality aspects, including noise level, structure fidelity, image
quality and clinical features.
The results confirmed that CardioBoost images are sufficient
for diagnosis and the image quality of CardioBoost is equal or
better than the image quality of KARL 3D over all of the
evaluation aspects.

The clinical images reconstructed with AIIR and FBP
respectively were shown to the readers to perform a five-point
scale evaluation of both image sets on the several image quality
aspects, including noise level, streaking artifact reduction and
image structure fidelity.
The results confirmed that AIIR images are sufficient for
diagnose and the image quality of AIIR is equal or better than
the image quality of FBP over all of the evaluation aspects.


The clinical images reconstructed with Motion Freeze were
shown to the readers to perform a 5-point scale evaluation of
both image sets on the image quality aspects, including artifact
correction effect and clinical diagnostic benefit of the images.
The results confirmed that Motion Freeze is helpful for both
artifact suppression and clinical diagnosis.

The clinical images with Ultra EFOV and EFOV respectively
were shown to the readers to perform a 5-point scale evaluation
of both image sets on the image quality aspects, including
image artifacts and homogeneity of same tissue.
The results confirm that the images with Ultra EFOV can
improve the accuracy of image CT numbers, in cases where the
scanned object exceeds the CT field of view.

AI motion correction is a new module integrated as a part of
CardioCapture in uCT ATLAS. Other modules are same as the
function cleared in K231482.
The reader evaluation is based on the CardioCapture function
with AIMC enabled. The evaluation aspects include:
·Contours are clear and continuous
·Motion artifacts of coronary arteries are tolerable
·Number of diagnostic coronaries reaches at least 50% of the
total number of coronary artery segments
The results conclude the effectiveness of CardioCapture
function for reducing cardiac motion artifacts as expected.


Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany

Brainlab Elements (7.0);
Brainlab Elements Image Fusion (5.0);
Brainlab Elements Image Fusion Angio (1.0);
Brainlab Elements Contouring (5.0);
Brainlab Elements Fibertracking (3.0);
Brainlab Elements BOLD MRI Mapping (1.0)

Automated Radiological Image Processing Software

Predicate Device
K223106; Brainlab Elements 6.0

Reference Device
K212397; StealthStation S8 Cranial v2.0

Sadwini Suresh
QM Consultant
Phone: +49 89 99 15 68 0
Email: regulatory.affairs@brainlab.com

Chiara Cunico
Senior Manager Regulatory Affairs
Phone: +49 89 99 15 68 0
Email: chiara.cunico@brainlab.com


Brainlab Elements, Brainlab Elements Contouring (5.0), Brainlab Elements Fibertracking (3.0), Brainlab
Elements Image Fusion (5.0), Brainlab Elements Image Fusion Angio (1.0), Brainlab Elements BOLD
MRI Mapping (1.0)

Brainlab Elements, Brainlab Elements Contouring (4.5), Brainlab Elements Fibertracking (2.0), Brainlab
Elements Image Fusion (4.5), Brainlab Elements Image Fusion Angio (1.0), Brainlab Elements BOLD
MRI Mapping (1.0)


Topic/
Primary Predicate Device (Brainlab
Subject Device (Brainlab Elements Image

Feature
Elements Image Fusion 4.5 (K223106))
Fusion 5.0)

Brainlab Elements Image Fusion is an application
for the co-registration of image data within
medical procedures by using rigid and deformable
registration methods. It is intended to align


intended to align anatomical structures
between data sets.
The device itself does not have clinical
indications.

anatomical structures between data sets. It is not
intended for diagnostic purposes.
Brainlab Elements Image Fusion is indicated for
planning of cranial and extracranial surgical
treatments and preplanning of cranial and
extracranial radiotherapy treatments.

The intended users are medical professionals.
Typical users are:
- Image Guided Surgery (IGS):
Neurosurgeons, Ear-Nose-Throat (ENT)
surgeons and Cranio-Maxillofacial (CMF)
surgeons including their assistants
Radiotherapy (RT): medical professionals who
perform radiation treatment planning (medical
physicists, radiation oncologists, dosimetrists,
physicians, etc.)

The intended users are medical professionals.
Typical users are:
- Image Guided Surgery (IGS): Surgeons
trained in the areas of neurosurgery, spine
and trauma surgery, ear-nose-throat (ENT)
surgery and craniomaxillofacial (CMF) surgery
including their assistants.
Radiotherapy (RT): medical professionals who
perform radiation treatment planning (medical
physicists, radiation oncologists, dosimetrists,
physicians, etc.).

In general, there are no demographic, regional
or cultural limitations for patients. It is up to the
user to decide if the system shall be used to
assist a certain procedure.

There are no demographic, regional or cultural
limitations for patients.

The system shall be used in a hospital office
environment or rooms appropriate for surgical
interventions or radiotherapy planning.

Brainlab Elements can be used on hardware
that fulfills the defined minimum requirements:
- Operating System: Windows 8.1 64bit
- Minimum 4 logical cores
- Minimum RAM: 6 GB
- Graphics: Direct X compatible
- Display Resolution: 1920 x 1080 (Full HD)

All platforms which fulfill the minimum
requirements:
IGS Workstation:
- Operating system: Windows 10
- minimum 4 physical cores
- RAM: 8 GB
- Graphics: DirectX 12 compatible
- Display resolution: 1920 x 1080 (Full HD)
IGS Server / Virtual Machine
- Operating System: Windows Server 2016
- RAM 16GB
RT Workstation:
- Operating System: Windows 10
- minimum 6 physical cores
- RAM: 48GB
- Graphics card: DirectX 12
- Display resolution: 1920 x 1080 (Full HD)
RT Server / Virtual Machine
- Operating System: Windows Server 2016
- minimum 12 physical cores


- Windows Server 2012 R2 / 2016 / 2019
- Windows 8.1
Windows 10

- Windows Server 2016
- Windows Server 2019
- Windows Server 2022
- Windows 10

Touch and mouse/keyboard control Touch and
mouse/keyboard control

DICOM 3D imaging Modalities, e.g. CT/XT,
MRI, NM/PET, OT, are supported for automatic
fusion.
Other modalities are supported for manual
fusion (alignment)

Rigid co-
registration,
rigid image
fusion

Automatic rigid co-registration (rigid fusion) of
3D DICOM image data: CT (incl. low-dose CT),
MR, OT (e.g. Perfusion), MR-DTI, MR-BOLD,
NM/PET, US (ultrasound).
Manual rigid co-registration (rigid fusion) of
other (unknown) 3D DICOM image data.

Automatic rigid co-registration (rigid fusion) of 3D
DICOM image data: CT (incl. low-dose CT), MR,
OT (e.g. Perfusion), MR-DWI, MR-BOLD, NM/PET,
US (ultrasound).
Manual rigid co-registration (rigid fusion) of other
(unknown) 3D DICOM image data.

GUI Technology: HTML
Single view layout:
- Axial view is displayed by default
- The user is able to switch to coronal and
sagittal views
- A toolbar is available on the right side to
access the data selection, fusion tools and
verification tools
- In the header, the user is able to approve or
reject the fusion result

The co-registration can be restricted to a
specific region of interest of the datasets by
means of a box.

The co-registration can be restricted to a specific
region of interest of the datasets by means of a
box and an ellipsoid.

Deformable
Registration /
Elastic Image
Fusion:
Distortion

Distortion Correction for cranial image data:
CT-MR, MR-MR (incl. DTI)

Distortion Correction for cranial image data: CT-
MR, MR-MR (incl. DTI)


Topic/
Primary Predicate Device (Brainlab
Subject Device (Brainlab Elements Image

Feature
Elements Image Fusion 4.5 (K223106))
Fusion 5.0)

Deformable
Registration /
Elastic Image
Fusion:
Curvature
Correction Spine

Curvature Correction for spinal image data:
CT-CT, CT-MR (incl. low-dose CT scanner)

Curvature Correction for spinal image data: CT-
CT, CT-MR (incl. low-dose CT scanner)

Deformable
Registration /
Elastic Image
Fusion: Virtual
iMRI Cranial

Calculation of a brain shift (“virtual iMRI”)
simulation, based on intra-operative CT or MR
image data, offering a simulation of pre-
operative planning data within an intra-
operative situation.
The intra-operative resection cavity is grayed
out in the simulation result.
With the acceptance of a Virtual iMRI
simulation, the original variant of an image set
and existing co-registrations are removed from
the current data selection

Calculation of a brain shift (“virtual iMRI”)
simulation, based on intra-operative CT, MR, or
US image data, offering a simulation of pre-
operative planning data within an intra-operative
situation.
The intra-operative resection cavity is blacked out
in the simulation result.
Automatic scrolling is activated as soon as a
simulation result is available.
With the acceptance of a Virtual iMRI simulation,
the original variant of an image set and existing
co-registrations are kept in the current data
selection

A spy glass superimposes the first image set in
a frame over the second image set.

Blending allows to view structures in two
image sets at the same time by using
complimentary colors to distinguish both image
sets.

Verification
Tools: Spy
Glass for
Deformable Co-
Registrations

For deformable registrations the spy glass
feature is combined with a heatmap and a
deformation grid, highlighting areas where the
deformed image set has been (locally)
modified and giving a global impression about
the deformation

Verification
Tools: Blending
for deformable
co-registrations

For deformable registrations the blending feature
is combined with a deformation grid, which gives a
global impression about the deformation while its
colored grid lines highlight areas where the
deformed image set has been (locally) modified.
For Virtual iMRI with Ultrasound, the weather
radar, a specific type of blending with distinct
colors, has been implemented.


Topic/
Primary Predicate Device (Brainlab
Subject Device (Brainlab Elements Image

Feature
Elements Image Fusion 4.5 (K223106))
Fusion 5.0)

Calculation of treatment response assessment
maps for the analysis of contrast agent
clearance.


Feature
Elements Image Angio 1.0.2 (K223106))
Fusion Angio 1.0.2)

Brainlab Elements Image Fusion Angio is a
software application that is intended to be used
for the co-registration of cerebrovascular
image data.
The device itself does not have clinical
indications.

Brainlab Elements Image Fusion Angio is a
software application that is intended to be used for
the co-registration of cerebrovascular image data.
It is not intended for diagnostic purposes. Brainlab
Elements Image Fusion Angio is indicated for
planning of cranial surgical treatments and
preplanning of cranial radiotherapy treatments.

The intended users are medical professionals.
Typical users are:
- Image Guided Surgery (IGS):
Neurosurgeons, Ear-Nose-Throat (ENT)
surgeons and Cranio-Maxillofacial (CMF)
surgeons including their assistants
Radiotherapy (RT): medical professionals who
perform radiation treatment planning (medical
physicists, radiation oncologists, dosimetrists,
physicians, etc.)

The intended users are medical professionals.
Typical users are:
- Image Guided Surgery (IGS): Surgeons
trained in the areas of neurosurgery including
their assistants.
Radiotherapy (RT): medical professionals who
perform radiation treatment planning (medical
physicists, radiation oncologists, dosimetrists,
physicians, etc.).

Brainlab Elements can be used on hardware
that fulfills the defined minimum requirements:
- Operating System: Windows 8.1 64bit
- Minimum 4 logical cores
- Minimum RAM: 6 GB
- Graphics: Direct X compatible
Display Resolution: 1920 x 1080 (Full HD)

All platforms which fulfill the minimum
requirements:
IGS Workstation:
- Operating system: Windows 10
- minimum 4 physical cores
- RAM: 8 GB
- Graphics: DirectX 12 compatible
- Display resolution: 1920 x 1080 (Full HD)
IGS Server / Virtual Machine
- Operating System: Windows Server 2016
- RAM 16GB
RT Workstation:
- Operating System: Windows 10
- minimum 6 physical cores


- RAM: 48GB
- Graphics card: DirectX 12
- Display resolution: 1920 x 1080 (Full HD)
RT Server / Virtual Machine
- Operating System: Windows Server 2016
- minimum 12 physical cores
- RAM: 64GB (+16GB per additional user)


Primary Predicate Device (Brainlab
Elements Contouring 4.5 (K223106))

Brainlab Elements Contouring provides
an interface with tools and views to
outline, refine, combine and manipulate
structures in patient image data. The
generated 3D structures are not intended
to create physical replicas used for
diagnostic purposes.
The device itself does not have clinical
indications

Brainlab Elements Contouring provides an
interface with tools and views to outline, refine,
combine and manipulate structures in patient
image data. It is not intended for diagnostic
purposes.Brainlab Elements Contouring is
indicated for planning of cranial and
extracranial surgical treatments and
preplanning of cranial and extracranial
radiotherapy treatments.

In general, there are no demographic,
regional or cultural limitations for
patients. It is up to the user to decide if
the system shall be used to assist a
certain procedure.

There are no demographic, regional or cultural
limitations for patients.

The system shall be used in a hospital
office environment or rooms appropriate
for surgical interventions or radiotherapy
planning.

The intended users are medical
professionals. Typical users are:
- Image Guided Surgery (IGS):
Neurosurgeons, Ear-Nose-Throat
(ENT) surgeons and Cranio-
Maxillofacial (CMF) surgeons
including their assistants
Radiotherapy (RT): medical professionals
who perform radiation treatment planning

The intended users are medical professionals.
Typical users are:
- Image Guided Surgery (IGS): Surgeons
trained in the areas of neurosurgery, spine
and trauma surgery, ear-nose-throat
(ENT) surgery and craniomaxillofacial
(CMF) surgery including their assistants.
Radiotherapy (RT): medical professionals who
perform radiation treatment planning (medical


(medical physicists, radiation oncologists,
dosimetrists, physicians, etc.)

physicists, radiation oncologists, dosimetrists,
physicians, etc.).

Brainlab Elements can be used on
hardware that fulfills the defined
minimum requirements:
- Operating System: Windows 8.1 64bit
- Minimum 4 logical cores
- Minimum RAM: 6 GB
- Graphics: Direct X compatible
- Display Resolution: 1920 x 1080 (Full
HD)

IGS Workstation:
- Operating system: Windows 10
- minimum 4 physical cores
- RAM: 8 GB
- Graphics: DirectX 12 compatible
- Display resolution: 1920 x 1080 (Full HD) IGS
Server / Virtual Machine:
- Operating System: Windows Server 2016
- RAM 16GB
RT Workstation:
- Operating System: Windows 10
- minimum 6 physical cores
- RAM: 48GB
- Graphics card: DirectX 12
- Display resolution: 1920 x 1080 (Full HD) RT
Server / Virtual Machine:
- Operating System: Windows Server 2016
- minimum 12 physical cores
- RAM: 64GB (+16GB per additional user)
If Anatomical Patient Model 1.1 (APM 1.1) shall
be used, the following minimum requirements
have to
be fulfilled:
- CPU: 12 (virtual) cores
- RAM: 24 GB
If the Cranial Tumor Segmentation feature of
Contouring shall be supported, the following
GPU
requirements have to be fulfilled:
- GPU vRAM: 8GB
- GPU driver: ≥ 472.5* (*cuda 11.8 tool kit
compatibility)
- CUDA compute capability: > 5.2

- Windows Server 2012 R2 / 2016 / 2019
- Windows 8.1
- Windows 10

- Windows Server 2016
- Windows Server 2019
- Windows Server 2022
- Windows 10

Input Devices
Touch and mouse/keyboard control
Touch and mouse/keyboard control

Cranial tumors are auto-segmented as 3D
objects in image sets with supported modality


Primary Predicate Device (Brainlab
Elements Contouring 4.5 (K223106))

(MR-t1 contrast enhanced) by means of a
machine learning algorithm.
Similar to other anatomical structures the user
can review, adjust or reject the tumor object.

The application automatically creates
segmentation objects by using an atlas-
based automatic segmentation of the
brain.
Workflow-relevant segmentation objects
are
created automatically or, if required by a
workflow, on a single button click.

The application automatically creates
segmentation objects by using an atlas-based
automatic segmentation of the
brain.
Workflow-relevant segmentation objects are
created automatically or, if required by a
workflow, on a single button click.
In addition auto-segmented objects can
optionally also be retrieved via the Anatomical
Patient Model 1.1 by means of a setting.

The application can display annotations.
Annotations cannot be changed or
removed.

The application can be used to display, define
and edit annotations and registration markers.

The application can be used to display two
fused images within one view. A slider is
available to blend from one image to another.

If an anomaly is detected, the application
automatically focuses the views on this
anomaly.
Anomaly detection is either the result of
the
atlas-based automatic segmentation of
the
brain or, on platforms with appropriate
GPUs, the result of a machine learning
algorithm. The GPU requirements are
listed
in the UniversalAtlasPerformer Test Plan
ML Abnormity Detection.

Automatic
Segmentation:
Anatomical objects
– Segmentation
Templates

The application also offers the possibility
to
define customized segmentation
templates.

Automatic
Segmentation –
Resection Cavity

A resection cavity object can be segmented
automatically based on ultrasound image data.
Similar to other anatomical or tumor objects,
the user can review, adjust or reject the
resection cavity object.


Manual Creation
and Refinement of
Objects

The application provides tools for manual
creation and refinement of segmentation
objects:
- SmartShaper
- Brush 3D / Erase 3D
- Brush 2D / Erase 2D
- Smart Brush

SmartBrush can be used for multi-modal
drawing, i.e. two images are used for
drawing in a multi-modal view layout.

SmartBrush can be used for multi-modal
drawing, i.e. two images are used for drawing
in the newly introduced blending view when
Blending Mode is active.

Manual Creation of
Objects: Threshold
Segmentation

The application provides a Threshold
Segmentation tool to create objects.
Threshold Segmentation supports MR,
CT, PET, US and Contrast Clearance
Analysis (CCA) data.
The size of a geometric ROI during
Threshold Segmentation can be adjusted.

The application provides a Threshold
Segmentation tool to create objects.
Threshold Segmentation supports MR, CT,
PET, US, Contrast Clearance Analysis (CCA)
and RGB data.
The size of a geometric ROI during Threshold
Segmentation can be adjusted and it can be
rotated.

The application provides tools for the
manipulation of objects:
- Copy
- Margins
- Smoothing
- Mirroring
- Shifting and Rotation
- Splitting
- Automatic Object Fitting

The application provides tools for logical
operations on objects:
- Union
- Subtract
- Intersect

The application provides functionality to
control the review state of objects. In
case
of leaving the application with
unreviewed
semi-automatically or automatically
created
objects, a message is displayed.

It is possible to create a printable report for
an object in a platform independent file
format, giving information about the object's
volume, its diameter according to the


Primary Predicate Device (Brainlab
Elements Contouring 4.5 (K223106))

format, giving information about the
object's
volume, its diameter according to the
Macdonald criteria and its response
evaluation criteria (RECIST).
If multiple objects are selected and a
volumetric report is created, it contains
information about all objects.

Drawing Tools for
the Spine SRS Use
Case

The application calculates a clinical
target
volume (CTV) and a cropped organ at risk
(OAR) object based on a manually
outlined
Gross Tumor (GTV).
CTV and OAR objects can be created
upon
button click, based on a guideline
published
by Cox et al. (2012) when adding a GTV
outline.
In a user session, multiple combinations
of
GTV, CTV and OAR can be created.

The application offers outlining features
for
cerebrovascular diseases. These features
shall be supported by utilization of
angiographic image data (i. e. 2D DSA)
and
projective fusions written by Image
Fusion
Angio.