syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).

lt provides tools to view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.

The software combines the following digital image processing and visualization tools:

Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
Automated Contouring on CT images
Creation of contours on images supported by the application without prior assignment of a planning CT
Manual and semi-automatic registration using rigid and deformable registration
Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points
Supports multi-modality image fusion
Visualization and contouring of moving tumors and organs
Management of points of interest including but not limited to the isocenter
Creation of simple geometric treatment plans
Generation of a synthetic CT based on multiple pre-define MR acquisitions

Device Description

The subject device with the current software version SOMARIS/8 VB80 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation. The current software version SOMARIS/8 VB80 are as follows:

Modifications in Advanced Contouring: Data for training and validation of Advanced Contouring was obtained through clinical collaborations from Asia, Australia, Europe, and America to provide variability in age, gender, geographic origin, etc. Both native and contrasted CT images are included.
Revised User Interface

AI/ML Overview

The provided text describes the regulatory clearance of "syngo.via RT Image Suite" and includes information about its performance evaluation. The focus of the performance data section is on the AI-based autocontouring feature.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the AI-based autocontouring feature were defined based on the Dice coefficient, a commonly used overlap metric. The text states:

"All tests passed the defined acceptance criteria on the geometric overlap with the ground truth. The evaluation results confirm the clinical safety and performance of the autocontouring feature."

While the specific numerical threshold for the Dice coefficient acceptance criterion is not explicitly stated in the provided document, the statement confirms that the results met the pre-defined criteria.

Table of Acceptance Criteria and Reported Device Performance:

Feature/Metric	Acceptance Criteria (Explicit)	Reported Device Performance (Implicit)
Autocontouring	Passed defined acceptance criteria on geometric overlap with ground truth (based on Dice coefficient)	"All tests passed the defined acceptance criteria on the geometric overlap with the ground truth. The evaluation results confirm the clinical safety and performance of the autocontouring feature."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: 413 subjects
Data Provenance: The test data was generated from an independent set not seen during training. It covers a wide range of CT scanners and acquisition parameters.
- Geographic Origin: Europe (IT, PT, CH, UK, NL, DE), North America (US, CA), South America (BR), Australia, Asia (JP, IN).
- Retrospective/Prospective: Not explicitly stated, but "obtained through clinical collaborations" suggests retrospective collection of existing clinical data.

Breakdown of Test Set Distribution (from Table 1):

Data Source: Europe: 58, US: 165, Canada: 39, South America: 78, Australia: 28, Asia: 33, unknown: 12
Body Region: Head&Neck: 113, Thorax&Abdomen: 216, Pelvis: 84
Gender: Male: 188, female: 174, Unknown: 51
Age: <=30: 1, [30-50]: 6, [50;70]: 46, >70: 20, unknown: 340
Slice thickness (in mm): <=1: 19, (1,2]: 207, (2,3]: 168, >3: 19
Manufacturer (Scanner): Siemens: 126, GE: 77, Philips: 140, unknown/others: 70

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Number of Experts: An "expert team" was used, but the specific number is not provided.
Qualifications: "based on well accepted international contouring guidelines". The specific qualifications of the experts (e.g., radiologist with X years of experience) are not detailed.

4. Adjudication Method for the Test Set:

The ground truth was established by an "expert team" and then followed by a "rigorous independent quality assessment." This suggests a form of review or adjudication, but the exact method (e.g., 2+1, 3+1) is not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The provided text describes a standalone performance evaluation of the AI algorithm (autocontouring feature) against a manually annotated ground truth. It does not mention a comparative study involving human readers with and without AI assistance to measure improvement in human performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes. The performance evaluation described is purely a standalone assessment of the AI-based autocontouring feature. It compares the algorithm's output directly to the "manually annotated ground truth" using the Dice coefficient.

7. The Type of Ground Truth Used:

Expert Consensus/Manual Annotation: "Manual ground-truth segmentations were annotated by an expert team based on well accepted international contouring guidelines, followed by a rigorous independent quality assessment."

8. The Sample Size for the Training Set:

The document states that the validation data (test set) was "20% of the available data." This implies the training set was the remaining 80% of the total available data. However, the total available data size for both training and validation is not explicitly stated. Thus, the specific numerical sample size for the training set cannot be determined from this text.

9. How the Ground Truth for the Training Set was Established:

While not explicitly detailed for the training set, the text mentions that "Data for training and validation of Advanced Contouring was obtained through clinical collaborations from Asia, Australia, Europe, and America to provide variability in age, gender, geographic origin, etc."
Given the method for the test set ("Manual ground-truth segmentations were annotated by an expert team"), it is highly probable that the ground truth for the training set was established through a similar process of expert manual annotation, though this is not explicitly confirmed for the training data in this section.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Siemens Medical Solutions USA, Inc. % Monsuru Bello Official Correspondent 810 Innovation Drive KNOXVILLE, TN 37932

Re: K232799

Trade/Device Name: syngo.via RT Image Suite Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: March 27, 2024 Received: March 27, 2024

Dear Monsuru Bello:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

April 26, 2024

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Locon Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K232799

Device Name

syngo.via RT Image Suite

Indications for Use (Describe)

syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk.

It also provides functionalities to create simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.

The software combines the following digital image processing and visualization tools:

• Multi-modality viewing and contouring of anatomical, functional, and multiparametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images

· Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)

· Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
· Automated Contouring on CT images
· Creation of contours on images supported by the application without prior
assignment of a planning CT
· Manual and semi-automatic registration using rigid and

deformable registration

· Supports the user in comparing, contouring, and adapting contours based

on datasets acquired with different imaging modalities and at different time points
· Supports multi-modality image fusion
· Visualization and contouring of moving tumors and organs
· Management of points of interest including but not limited to the isocenter
· Creation of simple geometric treatment plans
· Generation of a synthetic CT based on multiple pre-define MR acquisitions

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

K232799 - 510(k) Summary

1. Identification of the Submitter

Submitter / Primary Contact Person	Monsuru K Bello
	Regulatory Affairs
	monsuru.bello@siemens-healthineers.com
	+1(202) 856-6099
Secondary Contact Person	Clayton Ginn
	Regulatory Affairs
	clayton.ginn@siemens-healthineers.com
	+1 (865) 898-2692
Submitter Address	Siemens Medical Solutions, Inc. USA
	Molecular Imaging
	810 Innovation Drive
	Knoxville, TN 37932
	Establishment Registration Number: 1034973
Legal Manufacturer	Siemens Healthcare GmbH
	Siemensstr 1
	D-91301 Forchheim, Germany
	Establishment Registration Number: 3004977335
Importer/Distributor	Siemens Medical Solutions USA, Inc.
	40 Liberty Boulevard
	Malvern, PA 19355
	Establishment Registration Number: 2240869

2. Device Name and Classification

Product Name:	syngo.via RT Image Suite
Propriety Trade Name:	syngo.via RT Image Suite
Classification Name:	Medical Charged-Particle Radiation Therapy System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.5050
Device Class:	Class II
Product Code:	MUJ

3. Predicate Devices

Predicate Device:

Trade Name:	syngo.via RT Image Suite
Classification Name:	Medical Charged-Particle Radiation Therapy System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.5050
Device Class:	Class II

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Image /page/5/Picture/0 description: The image contains the logos for Siemens and Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

Product Code: MUJ 510(k) Number: K220783

4. Device Description

Modifications in Advanced Contouring: Data for training and validation of Advanced Contouring was obtained through clinical collaborations from Asia, Australia, Europe, and America to provide variability in age, gender, geographic origin, etc. Both native and contrasted CT images are included.
. Revised User Interface

5. Indications for Use

The software combines the following digital image processing and visualization tools:

Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
· Automated Contouring on CT images
Creation of contours on images supported by the application without prior assignment of a planning CT
Manual and semi-automatic registration using rigid and deformable registration
Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points
Supports multi-modality image fusion

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Image /page/6/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots in a circular pattern.

Visualization and contouring of moving tumors and organs
Management of points of interest including but not limited to the isocenter
Creation of simple geometric treatment plans
Generation of a synthetic CT based on multiple pre-define MR acquisitions

6. Indications for Use Comparison to the Predicate Device

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Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a cluster of orange dots.

7. Comparison of Technological Characteristics with the Predicate Device

The differences between the above referenced predicate device are listed at a high-level in the following table:

	Subject Device	Predicate Device
Feature	Siemens	Siemens
	syngo.via RT Image Suite(software version SOMARIS/8 VB80)	syngo.via RT Image Suite(software version SOMARIS/8 VB70)(510(k) number: K220783)
AdvancedContouring	Advanced Contouring tools (automatic contouring ofstructures, nudge 3D tool, etc.). Support of RapidResults Technology. Streamlined workflow to adaptcontours from a prior to a current planning CT("adaptive contouring").Modifications:• The existing, cleared Advanced Contouringfeature has been extended by additionalanatomical structures. There are no changeson the underlying DL-based autocontouringalgorithm.	Advanced Contouring tools (automatic contouring ofstructures, nudge 3D tool, etc.). Support of RapidResults Technology. Streamlined workflow to adaptcontours from a prior to a current planning CT("adaptive contouring").
UserInterface	syngo.via based GUIModifications:• Minor modifications on the UI. Restructuredand revised UI elements.	syngo.via based GUI

The remaining functions in syngo.via RT Image Suite remain unchanged compared to the predicate version.

. Beam Placement
Reference Point Management
Patient Marking
. Routine Contouring
. Advanced Contouring
Routine Structure Operations
Duplication of Structures and POIs
Structure Set Management
Rigid Alignment
Deformable Alignment
Dose Evaluation
Synthetic CT
Contouring on 4D Image Data
Lobe-Based Lung Ventilation
Routine Reading Functionality

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Image /page/8/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

Parallel Image Display
. Routine Annotation Functionality

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Testing - Software Verification and Validation

Software Documentation for Enhanced documentation Level per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, is also included as part of this submission. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence.

Performance Evaluation of the Algorithm

The Al-based autocontouring feature of syngo.via RT Image Suite was tested on 413 subjects. The test data was generated from an independent set that was not seen by the model during training stage to cover a wide range of CT scanners and typical CT acquisition parameters. The general guideline was to reserve 20% of the available data for validation. The test data covers:

. Regional distribution (Europe: IT, PT, CH, UK, NL, DE; North America: US, CA; South America: BR; Australia, Asia: JP, IN)
Demographic distribution: Male/female
Distribution by manufacturer of the scanner: GE, Siemens, Philips ●
Distribution in protocols of different slice thicknesses: between < 1 mm till > 3 mm
. Subgroup analysis regarding manufacturer, slice thickness and gender did not show any confounder.

Subgroup	# Validation data sets
Data Source	Europe: 58, US: 165, Canada: 39, South America: 78, Australia: 28, Asia: 33, unknown: 12
Body Region	Head&Neck: 113, Thorax&Abdomen: 216, Pelvis: 84
Gender	Male: 188, female: 174. Unknown: 51
Age	<=30: 1, [30-50]: 6, [50;70]: 46, >70: 20, unknown: 340
Slice thickness (in mm)	<=1: 19, (1,2]: 207, (2,3]: 168, >3: 19
Manufacturer	Siemens: 126, GE: 77, Philips: 140, unknown/others: 70

Table 1: Distribution of validation data across subgroups

Manual ground-truth segmentations were annotated by an expert team based on well accepted international contouring guidelines, followed by a rigorous independent quality assessment. The testing ensures the quantitative performance of the resulting segmentations by comparing them to the manually annotated ground truth based on the commonly used overlap metric Dice coefficient . All tests passed the defined acceptance criteria on the geometric overlap with the ground truth. The evaluation results confirm the clinical safety and performance of the autocontouring feature.

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Risk Analysis

The risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

Siemens hereby certifies that syngo.via RT Image Suite meets the following FDA Recognized Consensus standards listed below:

Standard	Version	Content	FDARecognitionNumber(if applicable)
ANSI AAMI IEC62304	:62304:2006/A1:2016	Medical device software - Software life cycleprocesses [Including Amendment 1 (2016)]	13-79
NEMA PS 3.1 -3.20 2022d	:2022	Digital Imaging and Communications inMedicine (DICOM) Set	12-349
ISO 14971	:2019	Application of Risk Management to MedicalDevices	5-125
IEC 62366-1	Edition 1.12020-06CONSOLIDATEDVERSION	Medical devices - Part 1: Application ofusability engineering to medical devices	5-129
ISO 15223-1	Fourth edition2021-07	Medical devices - Symbols to be used withinformation to be supplied by themanufacturer - Part 1: General requirements	5-134
ISO 20417	First edition2021-04Correctedversion 2021-12	Medical devices - Information to be suppliedby the manufacturer	5-135

9. Conclusion

syngo.via RT Image Suite has the same intended use and indication for use as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics, clinical and non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use. Siemens used the same testing with the same workflows as used to clear the predicate device. Siemens considers syngo.via RT Image Suite to be as safe, as effective and with performance substantially equivalent to the commercially available predicate device.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Subject Device	Predicate Device
syngo.via RT Image Suite	syngo.via RT Image Suite
(software version: SOMARIS/8 VB80)	(software version SOMARIS/8 VB70)
(510(k) number: K232799)	(510(k) number: K220783)
syngo.via RT Image Suite is a 3D and 4D image visualization,	syngo.via RT Image Suite is a 3D and 4D image visualization,
multi-modality manipulation and contouring tool that helps	multi-modality manipulation and contouring tool that helps
the preparation of treatments such as, but not limited to	the preparation of treatments such as, but not limited to
those performed with radiation (for example,	those performed with radiation (for example,
Brachytherapy, Particle Therapy, External Beam Radiation	Brachytherapy, Particle Therapy, External Beam Radiation
Therapy).	Therapy).
It provides tools to view existing contours, create, edit,	It provides tools to view existing contours, create, edit,
modify, copy contours of regions of the body, such as but	modify, copy contours of regions of the body, such as but
not limited to, skin outline, targets and organs-at-risk. It also	not limited to, skin outline, targets and organs-at-risk. It also
provides functionalities to create simple geometric	provides functionalities to create simple geometric
treatment plans. Contours, images and treatment plans can	treatment plans. Contours, images and treatment plans can
subsequently be exported to a Treatment Planning System.	subsequently be exported to a Treatment Planning System.
The software combines the following digital imageprocessing and visualization tools:• Multi-modality viewing and contouring of anatomical,functional, and multi-parametric images such as but notlimited to CT, PET, PET/CT, MRI, Linac CBCT images• Multiplanar reconstruction (MPR) thin/thick, minimumintensity projection (MIP), volume rendering technique(VRT)• Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique• Automated Contouring on CT images• Creation of contours on images supported by theapplication without prior assignment of a planning CT• Manual and semi-automatic registration using rigid anddeformable registration	The software combines the following digital imageprocessing and visualization tools:• Multi-modality viewing and contouring of anatomical,functional, and multi-parametric images such as but notlimited to CT, PET, PET/CT, MRI, Linac CBCT images• Multiplanar reconstruction (MPR) thin/thick, minimumintensity projection (MIP), volume rendering technique(VRT)• Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique• Automated Contouring on CT images• Creation of contours on images supported by theapplication without prior assignment of a planning CT• Manual and semi-automatic registration using rigid anddeformable registration
Supports the user in comparing, contouring, andadapting contours based on datasets acquired withdifferent imaging modalities and at different time points	Supports the user in comparing, contouring, andadapting contours based on datasets acquired withdifferent imaging modalities and at different time points
Supports multi-modality image fusion	Supports multi-modality image fusion
• Visualization and contouring of moving tumors andorgans	• Visualization and contouring of moving tumors andorgans
Management of points of interest including but notlimited to the isocenter	Management of points of interest including but notlimited to the isocenter
Creation of simple geometric treatment plans	Creation of simple geometric treatment plans
Generation of a synthetic CT based on multiple pre-define MR acquisitions	Generation of a synthetic CT based on multiple pre-define MR acquisitions