Import of images, structure set, plan, and dose according
to the DICOM RT standard.

For electron beams RayStation calculates dose by the
Monte Carlo technique. The electron beam phase space
is generated in run time by sampling from a phase space
model where the electrons are created at the secondary
scattering foil. Electron transport towards the patient
and energy transport and scoring in the patient is done
using the Monte Carlo algorithm.

For photon beams RayStation calculates dose by the
point kernel superposition method (a.k.a. Collapsed
Cone) or a Monte Carlo algorithm for radiation transport
(8.1 onwards). The incident energy fluence is modeled as
a superposition of a primary energy fluence and a scatter
energy fluence. The dose contribution from
contamination electrons is calculated by a pencil beam
algorithm.

For proton beams RayStation uses either the pencil
beam algorithm with the Fermi-Eyges formalism, or a
Monte Carlo algorithm for radiation transport (6.0
onwards). For passive beams the beam model accounts
for the collimator and compensator block. For scanning
beams the beam model accounts for the spot phase
space including effects of air-scatter and beam paths
through magnetic deflection elements. The user defined
block aperture is taken into account in spot selection and
optimization. In addition to this the relative biological
effect (RBE) of proton beams is taken into account,
resulting in a photon equivalent dose (8.1 onwards).

For brachy plans RayStation calculates dose based on the
TG43 formalism.

Displays the patient geometry with structures
superimposed on the image data together with the dose
distribution in transversal, sagittal, and coronal
directions.


Dose tracking scenarios including deformable
registration of one CT or CBCT to another and
subsequent deformation and accumulation of dose.

Tools for specifying a highly detailed geometrical model
of the eye based on measurements from ultrasound and
surgery. Support for positioning of tantalum clips. Import
and visualization of fundus images. Creation and dose
computation of proton plans with gaze angle based
treatment directions

Automatic generation of fallback plans using alternative
treatment machines and treatment techniques. User-
defined protocols specifies the setup of the fallback
plans which are automatically generated from the
protocols and optimized using dose mimicking functions.

Conversion of CBCT images to synthetic CT images that
can be used for more accurate dose calculations.

The user can define optimization settings such as
optimization tolerance and maximum number of
iterations as well as segmentation settings on the
multileaf collimator and the Pencil Beam Scanning spot
pattern. An interface for controlling the optimization
process is provided and the progress of optimization is
displayed in a view. The system generates control points
for step-and shoot MLC plans, Sliding Window plans
(DMLC), rotational plans (VMAT), 3DCRT plans, Wave Arc
plans, TomoTherapy plans (6.1 onwards), proton, Pencil
Beam Scanning plans, using the defined optimization
problem. The inverse planning can be carried out either
through a conventional inverse approach or by using
multi-criteria optimization (photons and protons only).

Yes, but not for
Wave Arc plans or
proton planning.

Computation and evaluation of dose-averaged linear
energy transfer for proton plans. LET is an additional
physical quantity that can be used to assess the
radiobiological effect of the proton radiation.

Possibility to include optimization functions on the dose-
averaged linear energy transfer in addition to the dose
for proton PBS.


Microsoft SQL database for storage of beam model
parameters, machine constraints and dose curves with
dosimetric data for treatment units.

Allowing MR-images as planning images and base dose
computation on material override ROIs.

The optimization functions are specified in terms of
objectives and constraints to form the optimization
problem that is solved by the optimization engine.

Manual and semi-automatic segmentation tools for
contouring ROIs slice by slice together with semi-
automated generation of the patient outline ROI.
The model-based segmentation technique allows for
semi-automatic delineation of structures by matching 3D
shape models of the structures to new image data.
With atlas-based segmentation, the user can define
templates consisting of already segmented image data
and use this template for segmentation of new patient
images.
With deep learning segmentation, the user can use
trained deep learning models for automatic
segmentation of new patient images. (The model
training is performed offline on clinical CT and structure
data.)

Yes, but not for
atlas based
segmentation or
deep learning
segmentation.

Microsoft SQL database for storage of all patient and
plan data. Not for long term storage.

The system computes a large set of plans according to
given rules and the user is provided with tools to select
good plans from these.

Generation of rotational proton arc plans. Support for
discrete PBS arcs.

Tools for transferring the clinical plan to a phantom and
recalculate dose. The output is the dose distribution in
DICOM format or a 2D dose plane and a QA report.
Predicted EPID response is retrieved by photon dose
computation in a specially designed phantom.


RBE (Relative Biological Effectiveness) models can be
defined and commissioned. For proton treatments (8.1
onwards), the user can select whether to look at RBE-
corrected dose or physical dose. Dose summation is only
possible for photon doses and RBE-corrected proton
doses.

Tools used to answer questions of how the dose
distribution would appear if the patient setup at the
time of treatment does not fully correspond to the
planning CT. A model of patient uncertainties such as CT
inaccuracy and setup errors is used to compute a set of
scenario doses for evaluation.
Up to version 8.1 the support was limited to
computation of one scenario at a time in Plan Evaluation.

Optimization where a model of patient uncertainties
such as CT inaccuracy, setup errors or organ motion is
used during the optimization.

Scripting gives programmatic access to functionality,
excluding user risk mitigations. Through scripting, the
clinic specific procedures can be automated. The
operating system and other applications can be
accessed.

Hardware based license, preventing unauthorized
useable copies to be made. Checksum control of binary
files to prevent tampering. Data in the patient and
machine databases only available for users with
administrator rights.

Planning for TomoTherapy machines is completely
integrated in RayStation. Also provides tools for
selection of targets and imaging angles for the
TomoTherapy machine to use for target tracking during
delivery.


Supported techniques: TH = TomoHelical, TD =
TomoDirect

A general concept where the treatment plan is adapted
during the course of treatment. Tools available today
include deformable dose accumulation, CBCT dose
calculation and replanning scenarios.

Approval of the preferred treatment plan and referenced
ROIs by authorized medical staff. Once a treatment plan
is approved, it is locked for any further modification.

Treatment plan creation with specification of plan
properties such as number of fractions and delivery
technique.

Evaluation of a single plan. Comparison of dose
distributions and DVH curves of two or three plans.

The undo stack is saved to the database, enabling
recovery of RayStation after crash. The user may redo all
or selected changes at reopen of patient after crash.

Setup of isocenter, beam arrangements and basic
aperture design. Export to laser systems for patient
marking.


RayStation 2024A SP3, 2024A, 2023B and 12A all use
standard office PCs as hardware platform.

RayStation 2024A SP3, 2024A, 2023B and 12A all use
Windows 10 Professional (or higher) and Windows Server
2012 R2 (or higher). See RayStation 2024A System
Environment Guidelines for details.

RayStation 2024A SP3, 2024A, 2023B and 12A are intended
for the same target population and anatomical sites; persons
that have been prescribed an external beam radiation
therapy or chemotherapy treatment.

Anatomical sites
Substantially Equivalent

In terms of human factors, the systems are considered
equivalent. Minor updates only. The user interfaces use the
same framework with the same controls and views.

RayStation 2024A SP3, 2024A, 2023B and 12A all comply
with the IEC 61217, IEC 62083, IEC 62304, IEC 62366-1 and
ISO 14971.


RayStation 2024A SP3, 2024A, 2023B and 12A all support CT,
PET and MR images for identifying patient organs and
contouring.

When evaluating and approving treatment plans, all
necessary data is presented to the user and available in print
in all systems.

None of the systems are intended for long term storage of
images or other patient data.

Network / remote
connections and
capabilities

All systems are capable of network transfer of patient data
using the DICOM protocol. RayStation 2024A SP3, 2024A,
2023B and 12A are designed for desktop use and for remote
access using standard virtualization techniques. Remote
connection to the system is verified in detail and equivalent
to local connection.

No architectural changes or major new features that affect
cyber security.


Added/updated function in
Description of the RayStation function
Compared to

Dose compensation point
computation for Tomo
Synchrony

A new way of computing the dose compensation point was added
since the previously exported position was suboptimal. The point
is calculated by taking the center of the volume formed of the
dose voxels with dose above 90% of the max dose.

Substantially
Equivalent. The
feature does not raise
different questions of
safety or
effectiveness

RayStation does not
populate
DoseCompensationPoint
correctly for TomoMotion
plans

Related to the item above. The DICOM export was updated so
that the dose compensation point coordinates in IDMS are
populated with the correct coordinates (as defined in the related
item above).

compared with predicate device, RayStation 12A is presented in the table below.


Most distal energy layer
missing causing ripples in
dose distribution for box
target in water phantom

Ripples sometimes occurred in the distal edge of Pencil Beam
Scanning dose distributions for box targets in water phantoms in
combination with some dose grid setups.

The improvement to adaptive replanning is to remove dialog
options to simplify the workflow and to allow the user to select
whether to include background dose or not.
Adaptive replanning allows the user to adapt the treatment to a
changing patient geometry. Reasons for when a patient is
selected for replanning can vary between treatment protocols.
Replanning should be performed when the plan is no longer
suitable for treatment and when it has become necessary to
adapt the plan to the new circumstances.
The prerequisite for adaptive replanning in RayStation is an
approved treatment plan. The approved treatment plan that is
selected for adaptation is called the base plan. The new adapted
plan will be a copy of the base plan. In previous versions of
RayStation there was a separate dialog for creation and editing of
adapted plans. The New/Edit adapted plan dialog displayed all
plan parameters copied from the base plan, and the parameters
(such as treatment machine) were editable.
To simplify the plan adaptation workflow with less options, and to
simplify the code design, the Create adaptive plan dialog in the
new version of RayStation only provides some basic plan
parameters such as plan name and selection of planning image
set. If the user wants to change other parameters, the plan can be
edited using the regular Edit plan dialog after creation.
Also, with previous versions of RayStation, adapted plans were
always made taking background dose into account. Either the
accumulated delivered dose for previous fractions (computed in
the Dose tracking module) or the planned dose for a number of
fractions. The background dose was considered when optimizing
the adapted plan on the new image set.


The new RayStation version makes it possible also to create
adapted plans without taking any background dose into account.
This change allows a quick and simple replanning workflow where
a base plan is quickly adapted to the daily patient geometry.

The Dose tracking module in RayStation is used to evaluate the
actual delivered dose to the patient to evaluate daily changes as
well as to evaluate trends as the treatment progresses. With
previous versions of RayStation it has been possible to do dose
tracking for one selected treatment plan. For each fraction it was
possible to import and to compute dose for the plan selected for
dose tracking on the treatment time image of the patient. When
considered needed a new plan, based on the original plan but
adapted to a new image of the patient, could be made and be
used as basis for subsequent dose tracking.
With the new version it is possible to select which treatment plan
or beam set to use for dose tracking per fraction, to be able to
fully simulate the actual treatment. In several scenarios you treat
with different plans on different fractions, e.g. based on bladder
filling. With the new version it is also possible to add and remove
fractions to the treatment course.
This limited change in RayStation makes the dose tracking
functionality more useful since they can be used in more
treatment scenarios.

Delete ROI contours in all
slices except every n:th

This change increases usability when the user manipulates patient
image contours.
When editing existing region of interests (ROIs) it sometimes is
efficient to delete contours on certain image slices and to let
RayStation's interpolation algorithm create new contours on
those slices. In previous versions of RayStation the user could
delete a complete ROI geometry or one contour at a time.
With the new version of RayStation, contours in several slices for
the selected ROI can be deleted, keeping contours in e.g. every
2nd, 3rd or 5th slice. Optionally, it is possible to define a limited
range of image slices within which to do this.

Allow voxelwise min/max
doses if scenario group
contains a single image set
Scripting access to
voxelwise min/max dose

This change enables an evaluation criterion for more scenarios
and brings scripting closer to what is already enabled for the user
through the device graphical user interface.


Possibility to compute voxelwise min/max doses as long as all
scenarios are on a single image set. The image set is no longer
restricted to being the nominal image.
Scripting access to the clinical goal results with respect to the
voxelwise min/max distributions for a scenario group. Scripting
access to the actual voxelwise min/max dose distribution. These
could not be accessed using scripting in previous versions.

Two new treatment machine settings for export have been added
in machine modeling to improve integration with Varian’s Aria
system.
1) Possibility to configure if jaws shall be exported as
ASYMX/ASYMY or X/Y. X/Y is set in the exported file (instead of
ASYMX/ASYMY) for machines that have this setting and all
segments in all beams are symmetrical.
2) Setting that will remove MLC settings from export for cone
plans, if all MLC positions are “withdrawn”.
The machine settings have been added for DICOM plans exported
from RayStation to comply with Varian’s Aria system.
Added the possibility to define the default DICOM export target.
This is useful to make the folder that is most often used for
export, the folder selected by default.
A new machine configuration for omitting pixel intensity
relationship attributes in the export has been added for enhanced
compatibility with other systems. In RayStation 11B, the attributes
(0028, 1040) Pixel Intensity Relationship and (0028, 1041) Pixel
Intensity Relationship Sign were added to the export of RT
Images. The value ‘OTHER’ for Pixel Intensity Relationship Sign has
recently been added to the DICOM standard and hence some
older systems cannot handle that value. This new option makes it
possible to exclude the attributes at export, when Pixel Intensity
Relationship Sign = ‘OTHER’.
Added possibility to select if option “Delete original DICOM files
after import” shall be default. This is useful to have the original
DICOM files deleted by default after import.

Change to increase usability by allowing the user to work with
optimization objectives and constraints for points of interest
(POI)s in a way similar to what was already available for regions of
interest (ROI)s.


Added/updated function in
Description of the RayStation function
Compared to

It is now possible to add objectives and constraints on POIs. The
supported function types are Min dose, Max dose and Target
dose. Otherwise, the functions work similar to ROI functions.
In this way it is possible to perform planning without delineating
targets and OARs.

Electron Monte Carlo dose
engine improvements

Minor improvements to the new electron Monte Carlo dose
engine version (introduced in RayStation 12A). The user
noticeable updates are multi-GPU support and support for
different shapes of collimator tips.
Multi-GPU: For performance reasons, the user can select to
distribute the computation on multiple GPUs if the computer
running RayStation has more than one GPU card. Distributing the
computation on multiple GPUs will make it faster. The computed
dose is identical between one or multiple GPUs and thus accuracy
is not affected.
Different tip shapes: The user can specify in the machine model if
the shape of the MLC and jaw tips should be focused or rounded.
Previously, focused tips were always used. The selected tip shape
is used during dose computation, giving a more accurate
description of the physical machine.

Substantially
Equivalent. The
feature does not raise
different questions of
safety or
effectiveness

The changes are done to achieve more exact simulation in
RayStation of how MLC leaves and jaws are positioned in the
machine during delivery.

The new Auto field-in-field tool is used to create a field-in-field
plan based on the primary prescription and a primary field that is
either defined by a target plus a user defined margin or by the
first segment in each beam. The algorithm starts with a primary
field and subfields are added iteratively to irradiate low dose
regions. The tool automatically:
- creates subfields based on low dose regions
- adjusts segment weights
- computes final dose and scales to prescription
The tool automates a workflow that previously has been possible
to do manually.

Segment weight
optimization using photon
Monte Carlo added

Optimizing with respect to only segment weights, called Segment
MU in the RayStation user interface, were previously only
available for one of the two clinical photon dose engines in
RayStation, the Collapsed Cone dose engine. Now segment weight


optimization is possible also when using photon Monte Carlo, the
other clinical photon dose engine in RayStation.
In the RayStation user interface, it’s possible to select to optimize
with respect to Segment shapes and/or Segment MU. In 12A
however, it was not allowed to start Segment MU only
optimization with photon Monte Carlo selected. With photon
Monte Carlo selected in 12A, it was only possible to optimize
Segment shapes individually or Segment shapes together with
Segment MU. With Collapsed Cone selected, it was possible in
12A to optimize Segment shapes individually, Segment MU
individually or Segment shapes together with Segment MU.
In 2023B all options are available with photon Monte Carlo
selected as well.
This change makes it possible to utilize the more accurate Monte
Carlo dose engine in more planning scenarios.

Photon Monte Carlo dose
engine: Improved positron
handling

The photon Monte Carlo dose engine has been improved with
respect to positron physics. For external beam treatment
energies, the difference in computed dose is small, but
remodeling of photon and electron Monte Carlo machine models
is required. The most noticeable change in computed dose before
remodeling is the output for larger field sizes for photon Monte
Carlo. There are no changes to the RayStation user interface.
This change further improves the accuracy of computed photon
Monte Carlo dose.

Improvements to
conformity of broad beams
when using compensator
smearing/gradient

For proton broad beam techniques, manual editing of the
compensator shape is sometimes done to optimize the dose
distribution. Clinics reported that for some plans where smearing
was applied after manual compensator editing, the modulation
got insufficient to cover the proximal edge of the target. For
proton broad beam techniques, "Compute beam SOBP" (spread
out Bragg peak) now traces through the actual shape of the
compensator and proton wedge (if present).
This change makes it easier to get a good conformance to the
target after manually editing the compensator or applying
smearing and gradient tools.

Linear energy transfer (LET) is a quantity that, in combination with
the dose, provides information about the biological effect of the
radiation. Typically, in risk organs you want to avoid high LET in
combination with high dose. High LET with low dose is more


acceptable. Areas of the body that receive high dose and high LET
can experience more cell death, which is desirable in the tumor,
but harmful to normal tissue.
The new version of RayStation supports optimization on dose-
averaged linear energy transfer (LETd) for protons. This can be
used to lower LET in risk organs, which could reduce potential side
effects of radiotherapy. Possibility to add Max LETd and Min LETd
optimization functions in addition to standard dose optimization
functions has been added.

Evaluation on converted
CBCT images for protons

This is a change to enable users to visualize proton dose on CBCT
images for evaluation only. The images cannot be used for
planning and the dose cannot be used clinically.
It is possible to compute an evaluation dose on converted CBCT
images for protons. It is not possible to use such an image for
planning. The conversion algorithms themselves are the same as
those already clinically available for photons.

PBS Arc is a new treatment technique in RayStation. However,
since the arc plans are exported as regular PBS plans, with many
fields per plan instead of many segments per field, this is an
administrative change.
RayStation 2023B includes optimization of discrete PBS arc plans
where the gantry is stationary during dose delivery, as opposed to
dynamic arc plans where the gantry moves during delivery.
Discrete PBS arc optimization involves:
- Many gantry angles per beam, where multiple energy layers are
delivered per gantry
angle.
- Easy setup including air gap computation for collision avoidance.
- Iterative reduction of energy layers during optimization to
reduce delivery time.
PBS arc plans must be converted into regular PBS plans with many
beams, to be available for export out of RayStation.

Separate clinical goals per
beam set and plan

This change increases usability for evaluation of clinical goals.
It is now possible to specify which dose to evaluate a specific
clinical goal on.
Clinical goals are clearly grouped by plan and beam set in the
GUI.

Substantially
Equivalent. The
feature does not raise
different questions of
safety or
effectiveness


Added/updated function in
Description of the RayStation function
Compared to

In previous versions all clinical goals are evaluated on the
currently selected dose (plan dose/beam set dose/beam
dose/etc).

Support and fixation
structures per beam set

This change increases usability by not forcing all beam sets to
have the same couch and fixation device settings.
This is to support the possibility to use different couches and
different fixation devices for different beam sets. (E.g. changing
treatment machine often means changing to a different kind of
couch.)
Only selected fixation and support ROIs will be included in dose
computation.

This change increases usability for creation of synthetic CT.
In previous versions, to create a sCT using the CBCT correction
algorithm or the virtual CT algorithm, the user had to provide a
pre-created deformable registration between refCT and CBCT as
well as a pre created Field of View (FOV) ROI on the CBCT. Also –
an external was required on the CBCT. The new functionality
allows sCT to be created from two rigidly registered refCT and
CBCT.

This change increases the usability when handling CBCT images.
The user can now freely choose the imaging system of a
converted CBCT image. Converted CBCT images fetch their HU-to-
mass density table from their imaging system rather than from
the imaging system of the reference CT image. As a result, the
modality of such images will correspond to that of the chosen
imaging system which in most cases will be CT instead of CBCT.

Various GUI improvements
throughout the system

- Adjusted treatment delivery information in Patient data
management module
- ROI/POI lists initially sorted alphabetically
- Sorting on sub-columns for some tables
- Reduced size of aperture shapes toolbar
- Show beam parts, Volume rendering settings and DRR settings
dialogs are now non-modal
- Improved performance of “Copy to all” of Visualization settings
in ROI/POI details
- Image conversion histogram updated to follow the color scheme
in the fusion view
- Show segment number in BEV
- Possibility to translate also plan reports and the Report Designer


These are changes for increased usability.
- Creating structures from template now have the option to
automatically update derived ROIs.
- Option to replace existing clinical goals when applying template.
- Option to replace existing optimization functions when applying
template.

These are changes for increased usability.
- Treat and Protect settings are now scriptable for all modalities.
Notably for protons and electrons.
- Possibility to copy objectives and constraints
- Function values are no longer automatically computed after final
dose
- Relative dose value has been added to Dose cloud visualization
- Faster saving of patient data
- Faster Bragg Peak rendering
- For DICOM data where a filter has been applied the Transfer
Syntax Implicit VR Little Endian will always be used

This change increases usability of the material visualization view.
Make the material visualization view less error prone and possible
to use with beam set specific support/fixation ROIs. This will lead
to limitations in the current functionality; no material view will be
shown when there is no computed dose, and the material
visualization view will only be shown for beam set and beam
doses. One extension to the current functionality is made;
material will be visualized for Bolus ROIs for beams with the Bolus
ROI assigned.

This is an administrative change for handling unique identifiers
(UIDs).
In the 2024A RayStation/RayCare releases, a joint goal is to be
able to deliver treatment plans using Varian TrueBeam machines.
In that interface, information about the RT Images/ Digitally
Reconstructed Radiographs (DRRs) that will be used for delivery
needs to be provided. To avoid incorrect RT Images being used at
patient positioning, RayStation needs to produce deterministic
UIDs for exported RT Images. The logic to generate DRRs has
previously been spread out and duplicated in various places in
RayStation. Now the modelling of DRRs will be centralized in the
RayStation domain model which will both solve the immediate


issues and decrease the risk of introducing future problems when
the DRR generation is updated.

This is a change to fulfill an administrative interface requirement
since a dose rate for a setup beam does not have any function.
Possibility to set a dose rate for RayStation setup beams when
using a Linac treatment machine.
The dose rate for setup beams is defined per Linac treatment
machine in RayPhysics.

Display brachy channel
numbers in 3D view

This is a change to increase usability.
It shall be possible to display channel numbers in the 3D view.

Substantially
Equivalent. The
feature does not raise
different questions of
safety or
effectiveness

This is a change to increase performance and accuracy of a
calculation. The specifications are the same and there is no design
change.
New algorithm for converting triangle mesh ROIs to voxel ROIs.
Improves accuracy of the conversions at first and last slice of ROI
and improves performance for cases with a lot of mesh ROIs.

These are changes to increase the usability of patient modeling
workflows.
- ROIs grouping by body site in DLS dialog
- Possibility to create ellipsoid ROIs
- Default names for MBS ROIs now follow the TG263 standard
- Improved non-uniform expansion/contraction of ROIs
- Delete multiple contours (keeping every n:th) now works in all
view directions
- Possibility to add colors for ROIs in RayMachine

This change improves the visualization of the image registration
workspace.
The ‘Deformation grid’ in the Deformable registration module
view now shows image set in the same direction as the reference
image set for easier comparison.
- The floating view in the Image registration module has been
updated and improved. It now works like it did in RayStation 11A
and earlier versions. Position, Direction


Added/updated function in
Description of the RayStation function
Compared to

(transversal/sagittal/coronal), Patient direction letters, Imaging
system name and Slice number are again displayed in the floating
view.

This is an administrative change to fulfill interface requirements
from other devices.
The new RayStation version supports indicating export of plans
with high MU values as High-Dose Technique Type plans. The
version also includes improved Dose Reference Description
handling.
In RayPhysics, it is possible to define MU thresholds for different
treatment techniques. The thresholds are defined per treatment
machine. When exporting a treatment plan, the DICOM tag (300A,
00C7) in the RTPlan is set to SRS for beams where MU exceeds the
threshold.
The population of the DICOM attributes Prescription Description
and Dose Reference Description has been updated. Previously,
default values were used to populate these attributes. For the
Dose Reference Description, it is now possible to select between
four different default modes for populating the values. This
setting can be configured per machine. It is also possible to set
user defined overrides for both attributes.
These options are added to reduce the need to manually edit the
properties after importing a plan into other systems.

Control points are key elements in defining the delivery of a
beam. They specify how the beam parameters change over the
course of the treatment delivery. A beam typically contains
multiple control points to describe the beam’s modulation and
movement. One important attribute of a control point is the
gantry angle.
It was found that for VMAT beams, the way RayStation used
decimal distances between control points could lead to treatment
plans that could not be delivered by the treatment machine (e.g.
because they violated machine constraints such as maximum
gantry speed) since the gantry angles had to be rounded to fewer
decimals when the plan was exported to DICOM.
In the new version the sliding window VMAT sequencing
algorithm has been modified to create control points with a


gantry spacing of exactly 2 degrees, as opposed to a gantry
spacing of maximum 2 degrees. This change ensures that the
created VMAT beams are deliverable on the treatment machine.

This change enables the previously existing functionality to be
used for one additional electronic portal imaging device (EPID).
The EPID QA functionality has now also been validated for Varian
Halcyon.
EPID measurements using a Varian Halcyon LINAC have been
added to the EPID QA validation. All validation measurements
pass the acceptance criteria, and the license for EPID QA can be
made available also for Varian Halcyon users.

Possibility to use
background proton dose
computed on converted
CBCT

With this change, a proton dose computed on a converted CBCT
image set can also be used as background dose in optimization
and in adapted plans.
With the previous version, it was possible to compute evaluation
dose on converted CBCT images for protons. The image
conversion algorithms are the same as those already clinically
available for photons.

Higher dose grid resolution
for proton PBS

In RayStation the dose grid defines the volume where dose is to
be computed. The finer resolution the dose grid has, the more
accurate is the computed dose. (The dose takes longer to
calculate with a finer dose grid, and more data is created, so there
are trade-offs between high resolution and performance.)
Previous versions of RayStation had support for a dose grid
resolution down to 1x1x1 mm.
For treatments of small areas, it can be beneficial to be able to
use very fine dose grids. Treatments of eye cancer is one such
example. To better support these kinds of treatments RayStation
now supports dose grid resolutions down to 0.5 mm when using
the proton PBS Monte Carlo and Pencil Beam dose engines. This
includes support for computing curves at this high resolution in
RayPhysics, as well as for computing proton curves at non-
uniform resolution in RayPhysics.

CUDA (Compute Unified Device Architecture) is a parallel
computing platform and API developed by NVIDIA, enabling
developers to leverage NVIDIA GPUs (Graphics Processing Units)
for general-purpose processing. It enhances performance by
allowing the execution of thousands of parallel threads. CUDA is
used in several algorithms in RayStation that utilize the GPU, e.g.,
in dose engines and algorithms for deformable registration.


The platform used for GPU computations in RayStation (CUDA)
has been upgraded to version 12.2 to support new hardware
environments and compiler versions. The platform upgrade does
not affect the use of GPU calculations withing the treatment
planning workflow.

• RES 91867/FSN 109886: DICOM export from the Virtual
Simulation module
• RES 94153/FSN 130646 Remove template material 'Silicon
[Si]'
• RES 94388/FSN 133261: Incorrect early exit in SSD
• RES 96156/FSN 148655: Density perturbation in
Perturbed dose and Robust eval gives a lower range
perturbation

Substantially
Equivalent. The
feature does not raise
different questions of
safety or
effectiveness

Fixed minor performance issues, such as crashes and low speed,
to bring product to its initial specifications.


Standard No.
Standard Title
Recognition no.

Radiotherapy equipment - Coordinates movements
and scales

Medical device software - Software life cycle
processes

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

Medical devices - Application of risk management to
medical devices

Medical electrical equipment - Requirements for the
safety of radiotherapy treatment planning systems

Health software and health IT systems safety
effectiveness and security - Part 5-1: Security -
Activities in the product life cycle


Verification and validation data used to demonstrate

function in RayStation
substantial equivalence

Electron Monte Carlo
dose engine
improvements

Dose engine validation, comparing calculated doses with
measured doses obtained from clinics, doses computed in
independent, well-established TPS, doses computed with
earlier versions of RayStation, and doses computed in
BEAMnrc/egs++ with Gamma evaluation criteria.

Yes. The successful
validation of this
feature demonstrates
that the device is as
safe and effective as
the predicate device.

Segment weight
optimization using
photon Monte Carlo
added

System-level performance of the optimization method
proposed in the subject device was compared with the
predicate through resulting plan dose and dose statistics for
auto breast planning, SMLC, and VMAT plans.

Photon Monte Carlo dose
engine: Improved
positron handling

Dose engine validation with Gamma evaluation criteria. After
recommissioning of the beam model, the dose differences
between photon Monte Carlo computed doses in RayStation
12A and RayStation 2024A are negligible. The dose engine
validation shows the same level of accuracy as before after
remodeling.

Evaluation on converted
CBCT images for protons

Test cases consist of CBCTs from the MedPhoton imaging ring
on a Mevion S250i system, as well as the on-board CBCT
systems on a Varian ProBeam and an IBA P1.
Test cases cover validation of 3D dose computed on both the
Corrected CBCT and Virtual CT. For each case, a ground truth
CT image has been prepared to serve as ground truth.
Test criteria:
Gamma 2%/2mm pass rate above 90% for proton MC/PB dose
computation
Gamma 3%/3mm pass rate above 95% for proton MC/PB dose
computation


FlorianAkpakpa
Headof RegulatoryAffairsandQualityAssurance
Sonio
Phone:+336 1938 7145
Email:florian.akpakpa@sonio.ai


1. Transthalamic or Cavum septum pellucidum or Midline
falx/Transventricularor ChoroidPlexus
2. Profile/Nuchaltranslucency
3. 4Chambers
4. Abdominalcircumference
5. Hand
6. Foot
7. Crown RumpLength

1. Transthalamic or Cavum septum pellucidum or Midline
falx/Transventricularor ChoroidPlexus
2. Transcerebellarview
3. Profile
4. LipsandNose
5. Orbits
6. 4Chambers
7. LVOT
8. RVOT
9. 3vessels/3vessels andtrachea
10. SagittalSpine
11. Abdominalcircumference
12. AxialBladder
13. AxialKidneys
14. Longbone
15. Hand
16. Foot
17. Externalgenitalia(femaleandmale)
18. Placentainsertion

Table1: Listof views pertrimesterthat canbeautomaticallydetectedby Sonio Detect


Table2: Listof a
natomicalstructures that canbeautom
aticallydetecte
dby Sonio


5
10(k) PremarketN
otificationSubmission

Viewname Qualitycriteria First Second/Third

Transcerebellar
Presenceof thecisternaMagna
X

Qualitycriteriaof the thorax and heart
views

Presenceof theinterventricularseptum
X
X

3vessels and3
Presenceof thePulmonaryartery
X

vessels and
Presenceof theascendingaorta
X

tracheaviews
Presenceof thesuperiorvenacava
X


Presence of the pulmonary artery with
visiblebifurcation


Presence of the plexus choroid (third
ventricle)


Table4: Listof characteristicsthat canbe automaticallyverifiedby Sonio Detect


21CFR892.1550-accessoryto
UltrasonicPulsedDopplerImaging
System
21CFR892.1560-accessoryto
UltrasonicPulsedEchoImagingSystem
21CFR892.2050-MedicalImage
ManagementandProcessingSystem

-SonioDetectautomaticallydetects
views
-SonioDetectautomaticallydetects
anatomicalstructureswithinthe
supportedviews
-SonioDetectautomaticallyverifiesthe
qualitycriteriaofthesupportedviewsby
checkingwhethertheyconformto
standardizedqualitycriteria.

-SonioDetectautomaticallydetects
views
-SonioDetectautomaticallydetects
anatomicalstructureswithinthe
supportedviews
-SonioDetectautomaticallyverifiesthe
qualitycriteriaandcharacteristicsofthe
supportedviews.

Securecloud-basedandstand-alone
softwarecompatiblewithultrasound
systemfromGEMedical,Samsungand
Canon

Securecloud-basedandstand-alone
softwarecompatiblewithultrasound
systemfromGEMedical,Samsung,
CanonandPhilips

Table5: Comparison of technologicalcharacteristics


Items (fetalultrasound views,
anatomicalstructures and
characteristicsautomatically
detected)

Automaticdetectionof 3D fetal
ultrasoundimages

Automaticdetectionof fetal
ultrasoundviews throughreadingof
annotationsonimages

Automaticdetectionof 8fetalbrain
anatomicalstructuresontheviews
“Transthalamic”,
“Transventricular”,
“Transcerebellar”atT2/T3

Automaticdetectionof 6fetal
thoraxandheartanatomical
structuresontheviews “Four
chambers”,“LVOT”, “RVOT”,
“Threevessels or Threevessels and
trachea”,“Abdominal
Circumference”,“Axialviewof the
kidneys”atT1

Automaticdetectionof 21fetal
thoraxandheartanatomical
structuresontheviews “Four
chambers”,“LVOT”, “RVOT”,
“Threevessels or Threevessels and
trachea”,“Abdominal
Circumference”,“Axialviewof the
kidneys”atT2/T3

Automaticdetectionof 4fetal
placentaanatomicalstructureson
theviews “Placentainsertion”,
“Placentalocation”atT2/T3

Table6: results of the standalone performancetesting


Automaticdetectionof 8fetal
CRL/NT/Profileanatomical
structuresontheviews “Crown
RumpLength”,“Nuchal
Translucency”,“Profile”atT1

Automaticdetectionof 6fetal
CRL/NT/Profileanatomical
structuresontheviews “Crown
RumpLength”,“Nuchal
Translucency”,“Profile”atT2/T3

Automaticdetectionof theAnterior
placentalocationfor theviews
“Placentainsertion”,“Placenta
location”atT2/T3

Automaticdetectionof thePosterior
placentalocationfor theviews
“Placentainsertion”,“Placenta
location”atT2/T3

Automaticdetectionof the“Female
sex”for fetalsex for theview
“ExternalGenitalia”

Automaticdetectionof the“Male
sex”for fetalsex for theview
“ExternalGenitalia”


Item
Proposed Device
Predicate Device
Remark

Medical image management and processing
system

Picture Archiving and Communications
System

The FDA has changed
its regulatory
classification of PACS
(Picture Archiving and
Communication
Systems), referring to it
now as MIMPS
(medical image
management and
processing systems) as
part of amended
regulatory
classification changes
made for radiology-
specific software.

Both LLZ and QIH are
product code of
Medical image
management and

Table 1 Comparison of general information


processing system, the
difference between
them is use different
algorithms.

The predicated device
includes more
applications, which is
discussed in the
following sections, than
the proposed device.
This difference will not
impact the safety and
effectiveness of the


uAI Portal is a software solution intended to
be used for viewing, manipulation,
communication, and storage of medical
images. It supports interpretation and
evaluation of examinations within healthcare
institutions. It has the following additional
indications:
 The Lower Extremity Vessel Analysis is
intended to provide a tool for viewing,
manipulating, and evaluating CTA
images of lower extremities.
 The Head and Neck Vessel Analysis is
intended to provide a tool for viewing,
manipulating, and evaluating imaging
datasets acquired with head and neck
CTA.

uWS-CT is a software solution intended to be
used for viewing, manipulation,
communication, and storage of medical
images. It supports interpretation and
evaluation of examinations within healthcare
institutions. It has the following additional
indications:
 The CT Oncology application is intended
to support fast-tracking routine
diagnostic oncology, staging, and follow-
up, by providing a tool for the user to
perform the segmentation and volumetric
evaluation of suspicious lesions in lung
or liver.
 The CT Colon Analysis application is
intended to provide the user a tool to

The intended use is
decreased. The
predicated device
includes more
applications, which is
discussed in the
following sections, than
the proposed device.
This difference will not
impact the safety and
effectiveness of the
device.


 The Coronary Analysis is intended to
provide a tool for viewing,
manipulating, and evaluating imaging
datasets acquired with CCTA.
 The Pulmonary Artery Analysis is
intended to provide a tool for viewing,
manipulating, and evaluating imaging
datasets acquired with CTPA.
 The Aorta Analysis is intended to
provide a tool for viewing,
manipulating, and evaluating imaging
datasets acquired with aorta CTA.

enable easy visualization and efficient
evaluation of CT volume data sets of the
colon.
 The CT Dental application is intended to
provide the user a tool to reconstruct
panoramic and paraxial views of jaw.
 The CT Lung Nodule application is
intended to provide the user a tool for the
review and analysis of thoracic CT
images, providing quantitative and
characterizing information about nodules
in the lung in a single study, or over the
time course of several thoracic studies.
 The CT Vessel Analysis application is
intended to provide a tool for viewing,
manipulating, and evaluating CT
vascular images. The Inner view
application is intended to perform a


virtual camera view through hollow
structures (cavities), such as vessels.
 The CT Lung Density Analysis
application is intended to segment
pulmonary, lobes, and airway, providing
the user quantitative parameters,
structure information to evaluate the lung
and airway.
 The CT Brain Perfusion application is
intended to calculate the parameters such
as: CBV, CBF, etc. in order to analyze
functional blood flow information about
a region of interest (ROI) in the brain.
The CT Heart application is intended to
segment heart and extract coronary
artery. It also provides analysis of
vascular stenosis, plaque and heart
function.


 The CT Calcium Scoring application is
intended to identify calcifications and
calculate the calcium score. The CT
Dynamic Analysis application is intended
to provide visualization of the CT
datasets over time with the 3D/4D
display modes.
 The CT Bone Structure Analysis
application is intended to provide
visualization and labels for the ribs and
spine, and support batch function for
intervertebral disk.
 The CT Liver Evaluation application is
intended to provide processing and
visualization for liver segmentation and
vessel extraction. It also provides a tool
for the user to perform liver separation
and residual liver segments evaluation.


Proposed device
uAI Portal
Lower Extremity
Vessel Analysis

Table 2 SE Discussion for different Advanced Applications


Proposed device
uAI Portal
Head and Neck
Vessel Analysis


Application
Function name
Proposed device
Predicate device
Remark

Coronary Analysis
Image Browsing
Yes
Yes
Same


Pulmonary Artery
Image Browsing
Yes
Yes
Same

Application Function name Proposed device Predicate device Remark


Proposed device
uAI Portal
Pulmonary
Artery Analysis

uWS-CT (K183170) provide vessel
segmentation results with organs. The uAI
Portal Pulmonary Artery Analysis offer
segmentation results of vessels. For the
evaluation of vessel, the difference in
segmentation between the predicate device
and proposed device will not impact the
safety and effectiveness of the device


Proposed device
uAI Portal
Aorta Analysis

Aorta Analysis
Image Browsing
Yes
Yes
Same

Organ segmentation results have slight
difference due to the different applied
algorithm of the predicate device and
proposed device. For the evaluation of
vessel, those other segmentation difference
between the predicate device and proposed
device will not impact the safety and
effectiveness of the device


Dice, DICE is
defined as
follows:
,
where G is


the ground
truth, and P is
the
segmentation
result.


Coronary Artery
Vessels segmentation
0.920

Head and Neck Vessel
Head vessel segmentation
0.902

Pulmonary Artery
Arteries segmentation
0.953

Lower Extremity Artery
Arteries segmentation
0.892

of Dice coefficient were shown in the table below:


Predicate Device
ProFound AI V3.0
K203822

Subject Device
ProFound Detection V4.0
K240417

Radiological Computer Assisted
Detection and Diagnosis Software

ProFound AI® V3.0 is a computer-
assisted detection and diagnosis
(CAD) software device intended to be
used concurrently by interpreting
physicians while reading digital
breast tomosynthesis (DBT) exams
from compatible DBT systems. The
system detects soft tissue densities
(masses, architectural distortions and
asymmetries) and calcifications in the
3D DBT slices. The detections and
Certainty of Finding and Case Scores
assist interpreting physicians in
identifying soft tissue densities and
calcifications that may be confirmed
or dismissed by the interpreting
Physician.

ProFound Detection V4.0 is a
computer-assisted detection and
diagnosis (CAD) software device
intended to be used concurrently by
interpreting physicians while reading
digital breast tomosynthesis (DBT)
exams from compatible DBT systems.
The system detects soft tissue densities
(masses, architectural distortions and
asymmetries) and calcifications in the
3D DBT slices. The detections and
Certainty of Finding and Case Scores
assist interpreting physicians in
identifying soft tissue densities and
calcifications that may be confirmed or
dismissed by the interpreting
Physician.


Symptomatic and asymptomatic
women undergoing mammography.

Image processing device intended to
aid in the detection, localization, and
characterization of soft tissue
densities (masses, architectural
distortions and asymmetries) and
calcifications in the 3D DBT slices.

Output Device
Softcopy Workstation
Softcopy Workstation

Supported Digital
Breast
Tomosynthesis
Systems

• Hologic Selenia
Dimensions/3Dimensions
• Hologic 3Dimentions (Clarity HD)
• GE Senographe Essential with
SenoClaire
• GE Senographe Pristina
• Siemens Mammomat Inspiration
both Standard and Empire
Reconstruction
• Siemens Mammomat Revelation
both Standard and Empire
Reconstruction

• Represented on a 0% to 100%
scale
• Certainty of Finding relative score
assigned to each detected region
• Case Score assigned to each case
(regardless of the number of
detected regions)


Implements view processing in three
steps.

Implements view processing in two
steps.

Included
The PCCP in the subject device
includes proposed modifications
related to extending supported DBT
image acquisition systems.


Minimum: 35
Maximum: 90
Mean: 63
25th percentile: 55
75th percentile: 71

White, non-Hispanic: 59%
Black, non-Hispanic: 10%
Asian or Pacific Islander, non-Hispanic:10%
American Indian or Alaska Native, non-Hispanic: 0.3%
Other or Multiracial, non-Hispanic: 8%
Hispanic: 12%

test population is provided in the table below:


Feature/ Attribute
Subject Device
Predicate
Discussion

O-arm O2 Imaging System
O-arm O2 Imaging

Classification
Class II
Class II
Identical

Product Code
OWB, OXO and JAA
OWB, OXO and JAA
Identical

The O-arm™ O2 Imaging
System is a mobile x-ray
system designed for 2D and
3D imaging for adult and
pediatric patients weighing
60lbs or greater and having
an abdominal thickness
greater than 16cm and is
intended to be used where a
physician benefits from 2D
and 3D information of
anatomic structures and
objects with high x-ray
attenuation such as bony
anatomy and metallic objects.
The O-arm™ O2 Imaging
System is compatible with
certain Image Guided
Surgery Systems.

The O-arm™ O2
Imaging System is a
mobile x-ray system
designed for 2D and 3D
imaging for adult and
pediatric patients
weighing 60lbs or greater
and having an abdominal
thickness greater than
16cm and is intended to
be used where a
physician benefits from
2D and 3D information
of anatomic structures
and objects with high x-
ray attenuation such as
bony anatomy and
metallic objects.
The O-arm™ O2
Imaging System is
compatible with certain
Image Guided Surgery
Systems.

The O-arm™ O2 Imaging
System is a mobile cone-
beam x-ray system with
isocentric motion options. It
allows 3D image
reconstruction using a 360-
degree rotation of the x-ray
source and detector within
closed gantry.

The O-arm™ O2 Imaging
System is a mobile cone-
beam x-ray system with
isocentric motion options.
It allows 3D image
reconstruction using a
360-degree rotation of the
x-ray source and detector
within closed gantry.

40 x 30 cm (RoHS
compliant, Flat-Panel
Detector using a CsI
scintillation)

Comparison of the Technological Characteristics


32 kW, RoHS compliant
generator with improved
electrical interface.

2D Imaging
2D Fluoroscopic
2D Fluoroscopic
Identical

Automatically stitched 2D
Radiographic (Long Film)

Available presets:
1. Standard 3D
2. HD3D (High Definition)
3. Enhanced Cranial
4. Low Dose 3D
5. SpineSmart Dose

Added new preset called
SpineSmart Dose (See below for
details) in our subject device

Available presets:
1. HD3D (high definition)
equivalent to 750
projections

Equivalent, with the addition of
4.3.0 features (KCMAR, SSD
and 3DLS) described in
Section 3 Device Description.

Known Component
Metal Artifact
Reduction
(“KCMAR”)/Medtronic
Artifact Reduction
(MAR)/ Medtronic
Implant Resolution
(MIR)

The Medtronic Implant
Resolution System feature
provides enhanced
visualization of supported
Medtronic implants by
reducing artifacts
generated by imaging
hardware, such as screws
and spinal implants, and
enhancing hardware
visibility.

The current system is
used for imaging
screws and implants,
however, it does not
have the feature to
reduce artifacts
generated by imaging
hardware, such as
screws and spinal
implants.

A dded Feature:
Known-Component Metal
Artifact Reduction (KCMAR)
is a specialized algorithm,
which suppresses this metal
artifact on pedicle screws using
the “known” geometry of those
screws.


Feature/ Attribute
Subject Device
Predicate
Discussion

O-arm O2 Imaging System
O-arm O2 Imaging

3D Long Scan
The 3D Long Scan feature
provides functionality to
specify start and end
positions for acquiring two
to three (depending on
length) auto-registered 3D
scans in combination with
the IGS system. The
maximum achievable length
for a 3D Long scan is
approximately 43.8 cm
(17.24 in).The minimum
scan length for a 3D Long
Scan is approximately 19.2
cm (7.6 in).

2D Long Film
The 2D Long Film mode
provides functionality for
acquiring an
intraoperative linear X-
ray scan. In this mode,
the O-arm™ O2 Imaging
System scans while the
gantry moves left/right
along the z-axis during
acquisition between the
positions stored in
memory presets 1 and 2.
When the saved memory
presets are stored at the
extremes of the z-axis,
the maximum length and
width of a 2D Long Film
image is 47 cm by 20 cm
at isocenter.

Added Feature:
3D Long Scan is the combination
of automatic registration with
navigation systems (e.g.,
Medtronic StealthStation), lateral
access to the patient, and a
navigated three-dimensional scan
of 15-43cm of the patient’s spine.
2D Long Film was validated
and FDA-cleared previously.

SpineSmart Dose
SSD mode is designed to
provide an additional
preset setting for standard
3D acquisitions with a
lower overall dose
reduction of around 70%
from the standard
acquisition protocols, for
spinal applications. The
rotor spins at 30° per
second, acquires images
at 30 frames per second,
and captures
approximately 100
projections.

Normal dose
In 3D acquisition
modes, the O-arm™ O2
system IAS creates a
series of pulsed x-ray
exposures throughout a
complete 360-degree
rotation of the gantry
rotor. The rotor spins at
30° per second,
acquires images at 30
frames per second and
captures approximately
391 projections.

Added Feature:
Spine Smart Dose feature
leverages Machine Learning
technology with existing O-
arm™ images to achieve
reduction in dose on the O-
arm™ O2 Imaging System. It
is an algorithm designed to
reduce the noise of 3D
reconstructions acquired from
fewer acquisitions so that
clinically viable 3D images can
be produced using fewer
projections.


Testing
Testing Methodology / Parameters
Overall Results

Spine Smart
Dose Clinical
Equivalence
Design
Validation

The Spine Smart Dose (SSD) feature uses a
sparse image acquisition, an FDK
reconstruction and a machine learning
denoising algorithm to provide images of
the spine at significantly lower dose
(around 70% lower dose to patient). In a
blinded review by board-certified
neuroradiologist involving 100 clinical

This clinical and cadaver image pair
validation study demonstrated that the
clinical value of the O-arm O2 4.3 SSD
images is clinically equivalent when
compared to corresponding images from the
Predicate Device (O-arm O2 4.2.0 Imaging
System) under the specified indications.


image pairs, O-arm™ O2 Imaging System
4.3.0 SSD images were deemed clinically
equivalent to O-arm™ O2 Imaging System
4.2.x Standard and Predicate High-
Definition modes. The dose of the SSD
images reviewed in this study were
approximately ¼ the dose of the
corresponding Standard images.

Phantom testing was performed on Spine
Smart Dose feature to verify the system
level requirements for Image Quality (3D
Line pair, Contrast, MTF, Uniformity and
Geometric accuracy) and Navigational
accuracy in terms of millimeters.

All the bench testing demonstrated Spine
Smart Dose met all the system level
requirements.

KCMAR
Clinical
Equivalence
Design
Validation

The 3D O-arm acquisitions reconstructed
using the predicate device without KCMAR
feature and the same acquisitions
reconstructed using the subject device with
KCMAR feature were compared for their
clinical equivalence. Board-certified
radiologists provided clinical utility scores
(1-5 scale) for the 40 image pairs from four
cadavers acquired using Standard 3D
imaging mode. The cadavers were of small,
medium, large, and extra-large habitus.
In the subsequent study, board-certified
radiologists provided clinical utility scores
for the 33 image pairs from two cadavers
acquired using other 3D imaging modes
(Low Dose, HD, and SSD). The cadavers
were of small and extra-large habitus.

This cadaver image pair validation study
demonstrated that the clinical value of the
KCMAR image with the O-arm O2 Imaging
System version 4.3.0 is statistically better
when compared to corresponding images
from the Predicate Device (O-arm O2
Imaging System version 4.2.0) under the
specified indications.

Phantom studies were used to qualitatively
compare the metal artifact reduction
between non-KCMAR and KCMAR
processed images with supported
Medtronic implants. In addition, phantom
studies were conducted to quantitatively
assess the accuracy of the implant location
in millimeters and degrees.

All the bench testing demonstrated
KCMAR met all the system level
requirements.

3D Long Scan
Clinical
Utility
Validation

Board-certified radiologists provided
clinical utility scores (1-5 scale) for
Standard, Standard 3DLS, and SSD 3DLS
acquisitions of three cadavers. The
cadavers were of small, medium, and extra-

This cadaver clinical utility study
demonstrated that the clinical utility of the
Standard 3DLS and SSD 3DLS with the O-
arm O2 Imaging System version 4.3.0 is
statistically equivalent when compared to


large habitus, and two of the cadavers were
instrumented with pedicle screw hardware.
Paired statistical equivalence testing of the
clinical utility scores was performed
between (1) the Standard (predicate) and
Standard 3DLS mode, and (2) the Standard
(predicate) and SSD 3DLS mode. Each test
was performed on 45 paired samples.

the corresponding Standard acquisition
mode that is available in the predicate
system (version 4.2.0).

Phantom testing was performed on the 3D
Long Scan feature to verify the system
level requirements for Image Quality (3D
Line pair, Contrast, MTF and Geometric
accuracy) and Navigational accuracy in
terms of millimeters.

All the bench testing demonstrated 3D Long
Scan met all the system level requirements.

Usability for the 3DLS, SSD, and KCMAR
features was assessed in multiple formative
evaluations and tested in two summative
validations with the clinically relevant users
in simulated use environments. Summative
validation of critical tasks and new
workflows for 3DLS and SSD was
conducted with surgeons, spine
representatives, and radiation technologists.
Summative validation of KCMAR critical
tasks and new workflows was conducted
with surgeons and spine representatives.

The 3DLS, SSD, and KCMAR features
passed summative validation. Results of the
summative validations provided objective
evidence the O-arm O2 Imaging System
with 4.3.0 software is safe and effective for
the intended users, uses, and use
environments.

Dosimetry studies were used to confirm the
dose accuracy (kV, mA, CTDI and DLP)
for the new acquisition features including
the Spine Smart Dose and 3D Long Scan.

All the dosimetry testing passed the system
level requirements.


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

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

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

IEC TR 60601-4-2 Edition 1.0 2016-05, Medical electrical equipment -
Part 4-2: Guidance and interpretation - Electromagnetic immunity:
performance of medical electrical equipment and medical electrical
systems

AAMI / ANSI / ISO 10993-1:2018/(R)2013, Biological evaluation of
medical devices – Part 1: Evaluation and testing within a risk management
process

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

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


Pre-determined criteria were utilized in validation tests to assess whether remote viewing and reviewing

with SonoSync matched the performance of local ultrasound systems.

Labeling materials is provided to inform users about the necessary specifications for safely and effectively

conducting remote diagnostic reviews and viewing.

training process, and there is no overlap among the three.


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.


The maximum temperature
of all temperature probes
shall not exceed 41℃.

Perform test according to
ANSI/AAMI ES60601-1

Perform test according to
NEMA MS 1, NEMA MS
3, NEMA MS 6 and
NEMA MS 9

SNR and Uniformity shall
fulfill the design
specification.

Biocompatibility
evaluation in agreement
with recommendations in
Use of International
Standard ISO 10993-1,
"Biological evaluation of
medical devices - Part 1:
Evaluation and testing

Materials of construction
and manufacturing
materials exempt from
testing according to the
Biocompatibility guidance
(Attachment G), the
510(k) numbers for
devices where these

All the materials of
patient-contacting
components for the Breast
Coil - 24 are identical to
uMR Omega which was
cleared in K230152 in
formulation, processing,
sterilization, and


materials have been
previously approved, or
full biocompatibility report
(assessment of
sensitization, irritation and
cytotoxicity risks) for
components that have
direct contact with the
patient.

geometry, and no other
chemicals have been
added (e.g., plasticizers,
fillers, additives, cleaning
agents, mold release
agents).

Perform test according to
IEC 60601-1-2 and IEC
60601-4-2

Conform with IEC 60601-
1-2 and IEC 60601-4-2

Evaluate the image
generated by Breast Coil-
24 with the same method
as the predicate device

Image quality is sufficient
for diagnostic use.

The U.S. Board Certified
radiologist approves that
image quality is sufficient
for diagnostic use.


Item
Subject Device:
Primary Predicate:
Secondary Predicate:
Reference Device:

InferRead Lung CT.AI
InferRead Lung CT.AI
Lung Nodule
ClearRead CT(K221612)

InferRead Lung CT.AI is
comprised of computer
assisted reading tools
designed to aid the
radiologist in the detection
of pulmonary nodules ≥
4mm during the review of
CT examinations of the
chest on an asymptomatic
population ≥ 55 years old.
InferRead Lung CT.AI
requires that both lungs be
in the field of view.
InferRead Lung CT.AI
provides adjunctive
information and is not
intended to be used without
the original CT series.

InferRead Lung CT.AI is
comprised of computer
assisted reading tools
designed to aid the
radiologist in the detection
of pulmonary nodules
during the review of CT
examinations of the chest
on an asymptomatic
population. InferRead
Lung CT.AI requires that
both lungs be in the field of
view. InferRead Lung
CT.AI provides adjunctive
information and is not
intended to be used without
the original CT series.

The Lung Nodule
Assessment and
Comparison Option is
intended for use as a
diagnostic patient-imaging
tool. It is intended for the
review and analysis of
thoracic CT images,
providing quantitative and
characterizing information
about nodules in the lung
in a single study, or over
the time course of several
thoracic studies.
Characterizations include
diameter, volume and
volume over time. The
system automatically
performs the
measurements, allowing
lung nodules and
measurements to be
displayed.

ClearRead CT is comprised
of computer-assisted
reading tools designed to
aid the radiologist in the
detection and
characterization of
pulmonary nodules during
the review of screening and
surveillance (low-dose) CT
examinations of the chest
on a non-oncological
patient population.
ClearRead CT requires
both lungs be in the field of
view and is not intended
for monitoring patients
undergoing therapy for
lung cancer or limited field
of view CT scans.
ClearRead CT provides
adjunctive information and
is not intended to be used
without the original CT
series.

Product Code
OEB, QIH
OEB, LLZ
LLZ, JAK
OEB, LLZ

Automatically
Locate and
Identify Lung
Nodules

The maximum axial plane
longest diameter and
shortest diameter, the mean

The maximum and axial
plane longest diameter,
mean diameter and volume

Short axis- longest
diameter perpendicular to
the long axis on the

Volume, maximum,
minimum, average axial
plane diameters

Detailed Comparison of the Subject and Predicate/Reference Devices


diameter, volume, mean
densities information are
provided.

slice(mm)
Long Axis- Longest
diameter on an axial slice
(mm)
Average\ Max 3D \
Effective diameter (mm)
Volume(mm3)
Mean densities (HU)


K231917
VEA Align (primary predicate)
January 2024

K172346
sterEOS (secondary predicate)
June 2018


This cloud-based software is
intended for orthopedic
applications in both pediatric
and adult populations.
2D X-ray images acquired in
EOS imaging’s imaging systems
is the foundation and resource
to display the interactive
landmarks overlayed on the
frontal and lateral images.
These landmarks are available
for users to assess patient-
specific global alignment.
For additional assessment,
alignment parameters compared
to published normative values
may be available.
This product serves as a tool to
aid in the analysis of spinal
deformities, degenerative
diseases, lower limb alignment
disorders, and deformities
through precise angle and
length measurements. It is
suitable for use with adult and
pediatric patients aged 7 years
and older.

The sterEOS Workstation is
intended for use in the fields of
musculoskeletal radiology and
orthopedics in both pediatric and
adult populations as a general
device for acceptance, transfer,
display, storage, and digital
processing of 2D X-ray images
of the musculoskeletal system
including interactive 2D
measurement tools.
When using 2D X-ray images
obtained with the EOS imaging
EOS system, sterEOS
Workstation provides interactive
3D measurement tools:
 To aid in the analysis of
scoliosis and related disorders
and deformities of the spine in
adult patients as well as
pediatric patients. The 3D
measurement tools include
interactive analysis based
either on identification of
anatomical landmarks for
postural assessment, or on a
model of bone structures
derived from an a priori image
data set from 175 patients (91
normal patients, 47 patients

This cloud-based software is
intended for orthopedic
applications in both pediatric
and adult populations.
2D X-ray images acquired in
EOS imaging’s imaging systems
is the foundation and resource
to display the interactive
landmarks overlayed on the
frontal and lateral images.
These landmarks are available
for users to assess patient-
specific global alignment.
For additional assessment,
alignment parameters compared
to published normative values
may be available.
This product serves as a tool to
aid in the analysis of spinal
deformities and degenerative
diseases, and lower limb
alignment disorders and
deformities through precise
angle and length
measurements. It is suitable for
use with adult and pediatric
patients aged 7 years and older.

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


Clinical judgment and
experience are required to
properly use the software.

with moderate idiopathic
scoliosis and 37 patients with
severe idiopathic scoliosis),
and dry isolated vertebrae
data for spine modeling. The
model of bone structures is
not intended for use to assess
individual vertebral
abnormalities and is indicated
only for patients 7 years and
older. For postural
assessment, a set of
comparative tools is provided
allowing the comparison of
performed measurements to
reference values for patients
over 18 years old.
 To aid in the analysis of lower
limbs alignment and related
disorders and deformities
based on angle and length
measurements. The 3D
measurement tools include
interactive analysis based
either on identification of lower
limb alignment landmarks or
as for the spine, on a model of
bone structures derived from
an a priori image data set.
The model of bone structures
is not intended for use to
assess individual bone


abnormalities. The 3D
package including model-
based measurements and
torsion angles is indicated
only for patients 15 years or
older. Only the 2D/3D ruler is
indicated for measurements in
patients younger than 15
years old.

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

The 3D spine modeling software
does not allow modeling of
vertebrae with severe congenital
deformities (e.g. hemivertebrae,
spina bifida, etc.). The modeling
of a spine that has a vertebrae
with a congenital deformity may
be generated leaving out the
vertebrae with the congenital
deformity.
The 3D models delivered by the
sterEOS software can only be
used for diagnostic purposes
with the corresponding 2D
images. They are designed to
display the spatial relationship
between anatomical structures
and are unable to highlight local
bone alterations such as:
 bones with significant
changes in geometry following
surgical intervention,


 fractures,
 osteophytes,
 fibrocartilage calluses.
The lower limb 3D model is
based on an adult type and, as a
result, is not suited to pediatric
lower limb 3D reconstruction.
3D modeling can become
inaccurate and even impossible
when anatomical structures
cannot be identified as such in
the following cases:
 prostheses or instruments
masking or replacing
anatomical markers,
 certain pathological conditions
that alter the bone
composition, such as
osteoporosis,
 impossibility to differentiate
the internal condyle from the
external condyle or the
internal tibial plate from the
external tibial plate.


Automated Radiological Image
Processing Software

Operating System
Windows + MAC
Windows
Windows + MAC
YES

VEA Align is designed for
surgeons and clinical staff, such
as physician assistants, who
have been trained to use the
application.

Clinicians (radiologists,
orthopedists, radiographers), 3D
Services persons, which have
been trained to use the
application.

VEA Align Alignment
Assessment mode is designed
for surgeons and clinical staff,
such as physician assistants,
who have been trained to use
the application.
VEA Align 3D mode is designed
for 3D Services team members.

YES
Alignment Assessment
mode is equivalent to
predicate VEA Align and
3D Mode is equivalent to
predicate sterEOS (3D
Services users).

The device is indicated only for
patients 7 years and older.

3D measurement tools are used
on adult and pediatric patients
over 7 years of age who suffer
from scoliosis and deformed
spine pathology and for patients
over 15 years of age with
deformed lower limb pathology.

Includes landmarks associated
with vertebral endplates needed
to calculate coronal and sagittal
clinical parameters. These
landmarks are adjustable by the
user.

Includes landmarks associated
with the pelvis and lower limbs
needed to calculate coronal and
sagittal clinical parameters.


These landmarks are adjustable
by the user.

Provides normative values used
to assess patients’ global
alignment

Provides color-coded clinical
parameters to display variance
from the defined normative
values

2D images display and basic
manipulation (zoom, panning)

Patient-specific clinical
parameters and calculations
based on published literature.

Alignment mode: The 3D model
supports the initial placement of
the patient anatomic landmarks
on the images using a machine
learning-based algorithm. It is
not displayed to the user and as
such it is not part of the device
outputs.

The 3D model is deformed
manually by the user through
control points up to matching
accurately the X-ray contours.

Alignment mode: The 3D model
supports the initial placement of
the patient anatomic landmarks
on the images using a machine
learning-based algorithm. It is
not displayed to the user and as
such it is not part of the mode
outputs.
3D mode: The 3D reconstruction
model is initialized by an AI
algorithm and then deformed
manually by the user through
control points up to matching

YES
Alignment Assessment
mode is equivalent to
predicate VEA Align. In
the 3D mode, the 3D
reconstruction model is
an output of the device
as for the secondary
predicate, sterEOS. The
difference between the
secondary predicate
sterEOS and the subject


accurately the X-ray contours.
The 3D reconstruction model is
an output of the 3D mode.

VEA Align is the
automatic initialization
using an AI algorithm for
VEA Align 3D model
reconstruction
generation. This
difference allows the user
to gain time
duringmanual
adjustment. This
difference does not
prevent VEA Align from
achieving its intended
purpose and does not
create a new risk in VEA
Align. Therefore, this
difference does not affect
device safety or
effectiveness.

User Interface
Computer
Computer
Computer
YES

Obtaining an image
Transferred from other devices
Transferred from other devices
Transferred from other devices
YES

Human Intervention
for interpretation and
manipulation of
images


Characteristic
Predicate Device
Subject Device
Substantially Equivalent?

representation and associated landmarks and
provide feedback on corrective adjustments.
Preoperative: allow user to consult the
preoperative state of the patient
Planning: allow user to define patient specific
surgical strategy
Rod: allow user to define the design of rods

spineEOS to conform with the
type of input data

Segmental Alignment
Interbody Implant
Osteotomy
Spondylolisthesis
Rod Curvature Management

Obtains an image and 3D model transferred
from other devices

Provides normative values used to follow the
impact of the planning on the patient
alignment

Provides color-coded clinical parameters to
display variance from the defined normative
values

Requires human intervention for
interpretation and manipulation of images

2D images and 3D model display and basic
manipulation (zoom, panning, and angles
measurements, plumbline, and possibility to
add comments on the image)

2D images and 3D spine display and basic
manipulation (zoom, panning, angles
measurements, plumbline, and possibility to
add comments on the image)

YES
The wording referring to the
representation of the spine in 3D
differs from the predicate to more
precisely describe the spine
representation. However, it
remains the same between the
predicate and the subject
spineEOS.


Pelvic Tilt (PT)
Sacral Slope (SS)
Pelvic Incidence (PI)
Pelvic Obliquity (PO)
Pelvic Axial Rotation
Sagittal Vertical Axis (SVA)
C7-CSL
PI-LL
T1 Pelvic Angle (TPA)
Cobb Angle
Kyphosis/Lordosis Angle
Knee Flexion/Extension Angle
Lordosis Percentage Distributions
Spondylolisthesis grade (i.e., Slippage
percentage)

Pelvic Tilt (PT)
Sacral Slope (SS)
Pelvic Incidence (PI)
Pelvic Obliquity (PO)
Sagittal Vertical Axis (SVA)
C7-CSL
PI-LL
T1 Pelvic Angle (TPA)
Cobb Angle
Kyphosis/Lordosis Angle
Knee Flexion/Extension Angle
Lordosis Percentage Distributions
Spondylolisthesis grade (i.e., Slippage
percentage)

YES
Pelvic Axial Rotation has been
removed from the subject device.
Cotyle Axis allows determination of
the patient frame in which clinical
parameters are computed. Pelvic
Axial Rotation is computed based
on Cotyle Axis. So, in the patient
frame the value is always 0 for this
parameter.


Predicate device: BriefCase Software
(K222692)

CINA-VCF is a radiological
computer aided triage and
notification software indicated for
use in patients aged 50 years and
over undergoing non-enhanced or
contrast-enhanced CT scans which
include the chest and/or abdomen.
The device is intended to assist
hospital networks and
appropriately trained medical
specialists within the standard-of-
care bone health setting in
workflow triage by flagging and
communication of suspected
positive cases of Vertebral
Compression Fractures (VCF)
findings.
CINA-VCF uses an artificial
intelligence algorithm to analyze
images and highlight cases with
detected findings on a standalone
application in parallel to the
ongoing standard of care image
interpretation. The device does not
alter the original medical image,
and it is not intended to be used as
a diagnostic device.
The results of CINA-VCF are
intended to be used in conjunction
with other patient information and
based on professional judgment to
assist with triage/prioritization of
medical images. Notified clinicians
are ultimately responsible for
reviewing full images per the
standard of care.

BriefCase is a radiological computer aided
triage and notification software indicated
for use in the analysis of chest and
abdominal CT images. The device is
intended to assist hospital networks and
appropriately trained medical specialists
within the standard-of-care bone health
setting in workflow triage by flagging and
communication of suspected positive
cases of Vertebral Compression Fractures
(VCFx) findings.
BriefCase uses an artificial intelligence
algorithm to analyze images and highlight
cases with detected findings on a
standalone application in parallel to the
ongoing standard of care image
interpretation. The device does not alter
the original medical image and is not
intended to be used as a diagnosis device.
The results of BriefCase are intended to
be used in conjunction with other patient
information and based on their
professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of
care.

Trained medical specialists within
standard-of-care bone health
settings

Hospital networks and appropriately
trained medical specialists within the
standard of-care bone health setting

Non-enhanced / contrast-
enhanced CT scans of the chest
and/or abdomen.


Algorithm
Artificial intelligence algorithm
Artificial intelligence algorithm

Presentation of compressed,
grayscale, unannotated images
that is marked “not for diagnostic
use”

Presentation of compressed, low-quality,
grayscale, unannotated image that is
captioned “not for diagnostic use”

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

-VCF image processing application
- Compatibility of use with the CINA
Platform device (worklist and
Image Viewer) or other medical
image communications device

- AHS module (orchestrator, image
acquisition);
- ACS module (image processing);
- Aidoc Desktop application for workflow
integration (feed and non-diagnostic
Image Viewer).


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

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

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

IEC TR 60601-4-2 Edition 1.0 2016-05, Medical electrical equipment -


Part 4-2: Guidance and interpretation - Electromagnetic immunity:
performance of medical electrical equipment and medical electrical
systems

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

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

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


Validation Type
Definition
Acceptance Criteria

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

1000
Average latency time of each frame (msec)


Validation Type
Average
Standard Deviation
95% CI

Summary Performance data, Standard Deviations & Confidence Intervals:


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


Summary Performance data, Standard Deviations & Confidence Intervals for Segmentation:


Trade Name
Trade Name
SMART Bun-Yo-Matic
Bonelogic

Computed tomography
DICOM Computed
tomography

Automated case report of
the 3D model of patient
anatomy, surgical
instrument parameters, and
visualization of implant

3D model of patient anatomy
and case report of the 3D
model patient anatomy

Perform measurements for
presurgical planning

Graphical user interface
(GUI) to a web application
used with a standard web
browser.

Graphical user interface
(GUI) that is standalone
application based.


Classification Description
21 CFR Section
Product Code

Automated Radiological Image Processing Software


Description
Decision
Subject Device (K240645)
Predicate Device (K230209)

Trade/Device name
Sonix Health
Sonix Health

Product Code
QIH (Subsequent Product Code: LLZ)
QIH (Subsequent Product Code: LLZ)

Regulation Number
21 CFR 892.2050
21 CFR 892.2050

Sonix Health is intended for
quantifying and reporting
echocardiography for use by or on the
order of a licensed physician. Sonix
Health accepts DICOM-compliant
medical images acquired from
ultrasound imaging devices. Sonix
Health is indicated for use in adult
populations.
Ultrasound images are acquired via the
B (2D), M, Pulsed-wave Doppler, and
Continuous-wave Doppler modes.

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

Inside of hospitals, clinics, and
physician’s offices.

Sonix Health utilizes artificial
intelligence to automate previous
manual quantification tasks, resulting
in increased efficiency for users. Our
system performs view classification
and measurements according to the US
ASE guidelines, and the users can
review and modify the results if
necessary.

PLAX LV, PLAX zoomed AV, PLAX
zoomed MV, PLAX zoomed AV&MV,
PLAX zoomed Aorta, A4C, A4C zoomed
LV, A4C RV-focused, A2C, A2C zoomed
LV, A3C, A3C zoomed LV, A5C, PSAX
level of great vessels, PSAX level of MV,
PSAX level of papillary muscles, PSAX
level of apex, SC4C, SC long axis IVC, M-
mode LA/Ao, M-mode LV, M-mode
TAPSE, CW Doppler MS, CW Doppler
MR, PW Doppler MV, CW Doppler AV in
parasternal, CW Doppler AV, CW Doppler
AR, CW Doppler TR, CW Doppler PV,
CW Doppler PR, PW Doppler RVOT, PW
Doppler LVOT, Mitral annulus TDI septal,
Mitral annulus TDI lateral, Tricuspid
annulus TDI lateral

PLAX LV, A4C, A4C Zoomed LV,
A2C, A2C zoomed LV, M-mode
LA/Ao, M-mode LV, CW Doppler
MS, CW Doppler MR, PW Doppler
MV, CW Doppler AV, CW Doppler
AR, CW Doppler TR, CW Doppler
PV, CW Doppler PR, PW Doppler
RVOT, PW Doppler LVOT, DTI MV
annulus

The identified predicate device within this submission is shown in the following table:


[B-Mode]
IVSd (2D), IVSs (2D), LVIDd (2D),
LVIDs (2D), LVPWd (2D), LVPWs (2D),
Ao (2D), LA (2D), RVOT (2D), LVOT
(2D), EF(Teich) (2D), RWT (2D),
LAESV A4C, LVESV A4C, LVEDV
A4C, LVGLS / LVSLS A4C, LARS A4C,
LACtS A4C, LVEF MOD A4C, SV MOD
A4C, RVEDA A4C, RVESA A4C, RVD1
A4C, RVD2 A4C, RVD3 A4C, RVFWS
A4C, RV FAC A4C, LVESV A2C,
LVEDV A2C, LAESV A2C, LVGLS/
LVSLS A2C, LVEF MOD A2C, LVGLS /
LVSLS A3C
[M-Mode]
LAd (M), LAs (M), Aod (M), Aos (M),
IVSd (M), IVSs (M), LVIDd (M), LVIDs
(M), LVPWd (M), LVPWs (M), EF(Teich)
(M), RWT(Teich) (M), SV(Teich) (M),
LVEDV(Teich) (M), LVESV(Teich) (M),
LVd Mass(ASE) (M), %FS (M), RV
TAPSE (M)
[Doppler]
MS Vmax, MS VTI, MS PHT, MR Vmax,
MR VTI, MV Peak E Vel, MV Peak A
Vel, MV DecT, AV Vmax, AV VTI, PV
Vmax, PV VTI, AR Vmax, AR PHT, PR
Vmax, PR EDV, TR Vmax, TR VTI,
RVOT Vmax, RVOT VTI, RVOT AccT,
LVOT Vmax, LVOT VTI, E' Sept, A' Sept,
S' Sept, E' Lat, A' Lat, S' Lat(Mitral), S' Lat
(Tricuspid)

IVSd (2D), IVSs (2D), LVIDd (2D),
LVIDs (2D), LVPWd (2D), LVPWs
(2D), LA (2D), Ao (2D), LVESV /
LVEDV (4CH), LAV (4CH), LVESV /
LVEDV (4CH), LVESV / LVEDV
(2CH), LAV (2CH), LVESV / LVEDV
(2CH), LA (mmode), Aorta (m-mode),
IVSd (m-mode), LVIDd (m-mode),
LVPWd (m-mode), IVSs (m-mode),
LVIIDs (m-mode), LVPWs (m-mode),
MV Peak E Vel, MV Peak A Vel, MV
Decel Time, e' (med), a' (med), s'
(med), LVOT Vmax, LVOT VTI,
RVOT Vmax, RVOT VTI, PV AccT,
TR Vmax, TR VTI, AR Vmax / PR
Vmax, AR PHT / PR PHT, MV Vmax,
MV VTI, MV, PHT, MR Vmax, MR
VTI, AV Vmax / PV Vmax, AV VTI /
PV VTI, RVOT (2D)

After the automated analysis is
complete, users can review and modify
the results as needed. The product is
intended for use by, or on the order of a
licensed physician.


New Device
Predicate Device
Additional Predicate Device

Trade Name
CDM Insights
AI-Rad Companion Brain MR
OnQ Neuro

AI-Rad Companion Brain MR
is a post- processing image
analysis software that
assists clinicians in viewing,
analyzing, and evaluating
MR brain images.
AI-Rad Companion Brain MR
provides the following
functionalities:
· Automatic segmentation
and quantitative analysis of
individual brain structures
and white matter
hyperintensities
· Quantitative comparison of
each brain structure with
normative data from a
healthy population
· Presentation of results for
reporting that includes all
numerical values as well as
visualization of these results

OnQ Neuro is a fully automated
post-processing medical device
software intended for analyzing
and evaluating neurological MR
image data.
OnQ Neuro is intended to provide
automatic segmentation,
quantification, and reporting of
derived image metrics. OnQ
Neuro is additionally intended to
provide automatic fusion of
derived parametric maps with
anatomical MRI data. OnQ Neuro
is intended for use on brain
tumors, which are
known/confirmed to be
pathologically diagnosed cancer.
OnQ Neuro is intended for
comparison of derived image
metrics from multiple time-
points.
The physician retains the ultimate
responsibility for making the final
diagnosis and treatment decision.

Intended Users
The device is intended for
The device is intended for
Radiologists, Oncologists

healthcare practitioners
healthcare professionals

familiar with the post-
familiar with the post

processing of magnetic
processing of magnetic

Technological Software Software Software Software Software

OnQ Neuro is a fully automated
post-processing medical device
software that is used by
radiologists, oncologists, and
other clinicians to assist with
analysis and interpretation of
neurological MR images. It
accepts DICOM images using
supported protocols and
performs 1) automatic
segmentation and volumetric
quantification of brain tumors,

Description
post-processing medical
VA40 is an enhancement to

device software that is
the predicate, AI-Rad

used by radiologists,
Companion Brain MR VA20

neurologists, and other
(K193290). Just as in the

trained healthcare
predicate, AI-Rad Companion

practitioners familiar with
Brain MR addresses the

the post-processing of
automatic quantification and

magnetic resonance
visual assessment of the

images. It accepts DICOM
volumetric properties of

images using supported
various brain structures based

protocols and performs:
on T1 MPRAGE datasets. In AI-

510(k) Summary for CDM Insights [K240680]


New Device
Predicate Device
Additional Predicate Device

Trade Name
CDM Insights
AI-Rad Companion Brain MR
OnQ Neuro

automatic segmentation
and quantification of brain
structures and lesions,
automatic post-acquisition
analysis of diffusion-
weighted magnetic
resonance imaging (DWI)
data, and comparison of
derived image metrics
from multiple time-points.
The values for a given
patient are compared
against age-matched
percentile data from a
population of healthy
reference subjects. White
matter hyperintensities
can be visualized and
quantified by volume.
Output of the software
provides numerical values
and derived data as graphs
and anatomical images
with graphical color
overlays.
CDM Insights output is
provided in standard
DICOM format as a
DICOM-encapsulated PDF
report.

which are known/confirmed to
be pathologically diagnosed
cancer, 2) automatic post-
acquisition analysis of diffusion-
weighted magnetic resonance
imaging (DWI) data and
optional automated fusion of
derived image data with
anatomical MR images, and 3)
comparison of derived image
metrics from multiple time-
points.
Output of the software
provides values as numerical
volumes, and images of derived
data as grayscale intensity
maps and as graphical color
overlays on top of the
anatomical image. OnQ Neuro
output is provided in standard
DICOM format as image series
and reports that can be
displayed on most third-party
commercial DICOM
workstations

and quantification of brain
VA40, the quantification and

structures and lesions,
visual assessment extends to

automatic post-acquisition
white matter hyperintensities

analysis of diffusion-
on the basis of T1 MPRAGE

resonance imaging (DWI)
datasets. These datasets are

data, and comparison of
acquired as part of a typical

derived image metrics
head MR acquisition. The

from multiple time-points.
results are directly archived in

The values for a given
PACS as this is the standard

patient are compared
location for reading by

against age-matched
radiologist. From a predefined

percentile data from a
list of 30 structures (e.g.

population of healthy
Hippocampus, Left Frontal

reference subjects. White
Grey Matter, etc.), volumetric

matter hyperintensities
properties are calculated as

can be visualized and
absolute and normalized

quantified by volume.
volumes with respect to the

Output of the software
total intercranial volume. The

provides numerical values
normalized values for a given

and derived data as graphs
patient are compared against

and anatomical images
age-matched mean and

with graphical color
standard deviations obtained

CDM Insights output is
reference subjects.

DICOM format as a
hyperintensities can be

DICOM-encapsulated PDF
visualized as a 3D overlay map

Software performs automatic
segmentation

functionality for automatic
for automatic segmentation

segmentation and
and volumetry of MPRAGE


New Device
Predicate Device
Additional Predicate Device

Trade Name
CDM Insights
AI-Rad Companion Brain MR
OnQ Neuro

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

Software performs automatic
quantification

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

Yes, using single and multi-
compartment diffusion models.

Yes, performs comparison of
derived image metrics from
multiple time points.

Brain White
Matter
Hyperintensities
Segmentation

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

Information on White Matter
Hyperintensities is not provided.

Brain White
Matter
Hyperintensities
Quantification

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

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


Creation of an image
series for a report.
Automatic transfer of
report to a PACS system.

The software is configured at
installation to receive input
DICOM files from a network
location, and output DICOM to a
network destination.

Archiving
series for a report.
for a morphometry report.

Automatic transfer of
Automatic transfer of

report to a PACS system.
generated maps and

Confirmation UI with basic
visualization functionality

visualization functionality
the need for a user interface after

Architecture
Cloud solution
Cloud solution and Edge
Cloud solution or within a

components deployed on
hospital’s IT infrastructure on a

customer premise.
server or PC-based workstation

Standard DICOM format as image
series and reports

CDM Insights is a medical
device software package

The OnQ Neuro is a stand-alone
medical device software package

Characteristics
VA40 is a medical device

Installation
Cloud
Server
Cloud or Server

Data Source
Data Source
DICOM images using
DICOM images using
DICOM images using supported

supported protocols
supported protocols
protocols


SubjectDevice
See-ModeAugmented
ReportingTool,Thyroid
(SMART-T)
(K240697)

21CFR892.2090
Radiological
computer-assisteddetection
anddiagnosissoftwarefor
lesionssuspiciousforcancer

21CFR892.2060
Radiological
computer-assisteddiagnostic
softwareforlesions
suspiciousofcancer

Device, Predicate Device, and Reference Device


See-ModeAugmented
ReportingTool,Thyroid
(SMART-T)isastand-alone
reportingsoftwaretoassist
trainedmedical
professionalsinanalyzing
thyroidultrasoundimages
ofadult(>=22yearsold)
patientswhohavebeen
referredforanultrasound
examination.
Outputofthedevice
includesregionsofinterest
(ROIs)placedonthethyroid
ultrasoundimagesassisting
healthcareprofessionalsto
localizenodulesinthyroid
studies.Thedevicealso
outputsultrasonographic
lexicon-baseddescriptors
basedonACRTI-RADS.The
softwaregeneratesareport
basedontheimageanalysis
resultstobereviewedand
approvedbyaqualified
clinicianafterperforming
qualitycontrol.
SMART-Tmayalsobeused
asastructuredreporting
softwareforfurther
ultrasoundstudies.The
softwareincludestoolsfor
readingmeasurementsand

BU-CADisasoftware
applicationindicatedtoassist
trainedinterpreting
physiciansinanalyzingthe
breastultrasoundimagesof
patientswithsofttissue
breastlesionssuspiciousfor
breastcancerwhoarebeing
referredforfurtherdiagnostic
ultrasoundexamination.
Outputofthedeviceincludes
regionsofinterest(ROIs)and
lesioncontoursplacedon
breastultrasoundimages
assistingphysicianstoidentify
suspicioussofttissuelesions
fromuptotwoorthogonal
viewsofasinglelesion,and
region-basedanalysisof
lesionmalignancyuponthe
physician’squery.The
region-basedanalysis
indicatesthescoreoflesion
characteristics(SLC),and
correspondingBI-RADS
categoriesinuser-selected
ROIsorROIsautomatically
identifiedbythesoftware.In
addition,BU-CADalso
automaticallyclassifieslesion
shape,orientation,margin,
echopattern,andposterior
featuresaccordingtoBI-RADS
descriptors.

KoiosDSisanartificial
intelligence(AI)/machine
learning(ML)-based
computer-aideddiagnosis
(CADx)softwaredevice
intendedforuseasan
adjuncttodiagnostic
ultrasoundexaminationsof
lesionsornodules
suspiciousforbreastor
thyroidcancer.
KoiosDSallowstheuserto
selectorconfirmregionsof
interest(ROIs)withinan
imagerepresentingasingle
lesionornoduletobe
analyzed.Thesoftwarethen
automaticallycharacterizes
theselectedimagedatato
generateanAI/ML-derived
cancerriskassessmentand
selectsapplicable
lexicon-baseddescriptors
designedtoimproveoverall
diagnosticaccuracyaswell
asreduceinterpreting
physicianvariability.
KoiosDSmayalsobeusedas
animageviewerof
multi-modalitydigital
images,includingultrasound
andmammography.The
softwareincludestoolsthat


annotationsfromtheimages
thatcanbeusedfor
generatingastructured
report.
Patientmanagement
decisionsshouldnotbe
madesolelyonthebasisof
analysisbySee-Mode
AugmentedReportingTool,
Thyroid.

BU-CADmayalsobeusedas
animageviewerof
multi-modalitydigitalimages,
includingultrasoundand
mammography.Thesoftware
includestoolsthatallowusers
toadjust,measureand
documentimages,andoutput
intoastructuredreport(SR).
Patientmanagementdecisions
shouldnotbemadesolelyon
thebasisofanalysisby
BU-CAD.

allowuserstoadjust,
measureanddocument
images,andoutputintoa
structuredreport.
KoiosDSsoftwareis
designedtoassisttrained
interpretingphysiciansin
analyzingthebreast
ultrasoundimagesofadult
(>=22years)female
patientswithsofttissue
breastlesionsand/or
thyroidultrasoundsofall
adult(>=22years)patients
withthyroidnodules
suspiciousforcancer.When
utilizedbyaninterpreting
physicianwhohas
completedtheprescribed
training,thisdeviceprovides
informationthatmaybe
usefulinrecommending
appropriateclinical
management.

Patientswiththyroid
nodules
whoarebeingreferred
forultrasoundscan
(Prescriptiononly)

Patientswithsoft
tissuebreastlesions
whoarebeingreferred
forultrasound
interpreting
(Prescriptiononly)


Thesubjectdeviceisa
stand-alone,web-based
imageprocessingand
reportingsoftwarefor
localization,characterization
andreportingofthyroid
ultrasoundimages.
Thesoftwareanalyzes
thyroidultrasoundimages
andusesmachinelearning
algorithmstoextractspecific
information.Thealgorithms
canidentifyandlocalize
suspicioussofttissue
nodulesandalsogenerate
lexicon-baseddescriptors,
whichareclassified
accordingtoACRTI-RADS
(composition,echogenicity,
shape,margin,andechogenic
foci)withacalculated
TI-RADScategoryaccording
totheACRTI-RADSchart.
Thesoftwarethengenerates
areportbasedontheimage
analysisresultstobe
reviewedandapprovedbya
qualifiedclinicianafter
performingqualitycontrol.
Anyinformationwithinthis
reportcanbechangedand
modifiedbytheclinicianif
neededduringquality
controlandbeforefinalizing
thereport.

BU-CADisasoftwaresystem
designedtoassistusersin
analyzingbreastultrasound
imagesincludingidentification
ofregionssuspiciousforbreast
cancerandassessmentoftheir
malignancy.BU-CADconsists
ofaviewer,alesion
identificationmodule,anda
lesionanalysismodule.
Thelesionidentification
moduleidentifiesregionsof
interest(automatedROIs)ofa
singlesuspicioussofttissue
lesioninuptotwoorthogonal
viewsofbreastultrasound
imagesforassistingusersin
detectingsofttissuelesions.
Additionally,thelesion
identificationmodule
generatesanROIandalesion
contouroneachbreast
ultrasoundimage.
Thelesionanalysismodule
analyzesgivenROIsofabreast
lesiononultrasoundimages,
andgeneratesascoreoflesion
characteristics(SLC)interms
ofmalignancyorbenignityofa
lesion,BI-RADScategory,and
BI-RADSdescriptors.

KoiosDSisa
computer-aideddiagnosis
(CADx)softwaredevice
intendedforuseasan
adjuncttodiagnostic
ultrasoundexaminationsof
lesionsornodules
suspiciousforbreastor
thyroidcancer.
KoiosDSallowstheuserto
selectorconfirmregionsof
interest(ROIs)withinan
imagerepresentingasingle
lesionornoduletobe
analyzed.KoiosDSsoftware
containsfunctionalityfor
automaticallyclassifying
thyroidnodulessuspicious
forcancer.
Thesystemgeneratesan
outputalignedtoeitherthe
TI-RADSorATAclassification
guidelines.Thesystem
automaticallygenerates
user-modifiablethyroid
noduledescriptors
(Composition,Echogenicity,
Shape,Margin,Echogenic
Foci)andadirect,
image-derivedcancerrisk
assessmentthatistranslated
intoanoptional
lexicon-specific(TI-RADSor
ATA)modifier.