Who is the manufacturer of ART-Plan?

Therapanacea filed the 510(k) submission for ART-Plan (K232479).

What is the FDA product code for ART-Plan?

MUJ. It is classified under 21 CFR 892.5050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ART-Plan?

510(k) clearance (submission type: Traditional).

Does ART-Plan use AI or machine learning?

Yes. ART-Plan (K232479) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for ART-Plan?

Ethos Treatment Management, 2.1 (K212294); Ethos Treatment Planning, 1.1 (K212294).

Who can help prepare an FDA 510(k) submission like ART-Plan?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like ART-Plan get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

ART-Plan

K232479 · Therapanacea · MUJ · Dec 22, 2023 · Radiology

Device Facts

Record ID	K232479
Device Name	ART-Plan
Applicant	Therapanacea
Product Code	MUJ · Radiology
Decision Date	Dec 22, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

ART-Plan is a software intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists and radiation oncologists. The software consists of different applications, each used for specific purposes at a different phase of radiation treatment planning. ART-Plan offers the following tools to aid in the workflow of radiotherapy treatment: - Multi-modal visualization and rigid- and deformable registration of anatomical and . functional images such as CT, MR, PET-CT, 4D-CT, CBCT and synthetic-CT generated from CBCT - Display of fused and non-fused images to facilitate the comparison and delineation of image data by the user - Manual generation, modification and semi-automatic generation of contours for the ● regions of interest - Automatic generation of contours for organs at risk and healthy lymph nodes, based ● on medical practices, on medical images such as CT and MR images - Generation of synthetic-CT from MR images for supported anatomies - Generation of synthetic-CT from CBCT images for supported anatomies ● - Dose computation on CT and/or synthetic-CT images for external beam irradiation ● with photon beams - Assisted CBCT-based off-line adaptation decision-making for supported anatomies The device is intended to be used in a radiation therapy clinical setting, by trained professionals only.

Device Story

ART-Plan is a standalone software application for radiotherapy treatment planning. It ingests multi-modal medical images (CT, MR, PET-CT, 4D-CT, CBCT) via DICOM. The device uses deep-learning algorithms to perform automatic segmentation of organs at risk and lymph nodes, rigid/deformable image registration, and generation of synthetic-CT images from MR or CBCT inputs. It also provides a dose computation engine for photon beam external beam irradiation and assists in off-line adaptive radiotherapy decision-making. Used in clinical settings by radiation oncologists, physicists, and dosimetrists, the software displays fused/non-fused images and contours to facilitate treatment planning. The output supports clinical decision-making regarding treatment adaptation and plan validation. Benefits include standardized workflows, reduced manual contouring time, and improved accuracy in dose calculation for adaptive radiotherapy.

Clinical Evidence

No clinical studies were conducted. Evidence consists of bench testing, including qualitative and quantitative validation of auto-segmentation, image registration, synthetic-CT generation, and dose computation modules. Performance metrics included Dice Similarity Coefficient (DSC) (mean ≥ 0.8 for segmentation; ≥ 0.81 for registration), Target Registration Error (TRE < 2mm), and gamma passing rates (≥ 95% for 2%/2mm). Qualitative evaluations by experts used a 3-point scale (A/B/C), with acceptance criteria requiring ≥ 85% A+B scores. Testing used retrospective clinical data cohorts (e.g., 315,373 samples for auto-segmentation) to demonstrate generalization and non-inferiority to predicate devices.

Technological Characteristics

Standalone software application; accessed via web browser (Chrome, Firefox, Edge) on PC/tablet/phone. Uses deep learning algorithms for auto-segmentation, image registration, and synthetic-CT generation. Supports DICOM 3.0 interoperability. Dose engine performs photon beam calculations. Software is classified as 'major' level of concern. No hardware components; sterilization not applicable.

Indications for Use

Indicated for cancer patients prescribed radiotherapy treatment for whom relevant modality imaging data is available. Not intended for patients < 18 years. Users: trained medical professionals (radiotherapists, radiation oncologists, medical physicists, dosimetrists). Environments: hospitals, clinics, and radiation therapy facilities.

Regulatory Classification

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.

Predicate Devices

Ethos Treatment Management, 2.1 (K212294)
Ethos Treatment Planning, 1.1 (K212294)

Reference Devices

ART-Plan v1.10.1 (K230023)
ECLIPSE WITH AAA (K041403)
Eclipse Treatment Planning System (K102011)

Related Devices

K220813 — ART-PLAN · Therapanacea · Jun 17, 2022
K234068 — ART-Plan (v.2.2.0) · Therapanacea Sas · Apr 22, 2024
K230023 — ART-Plan · Therapanacea Sas · Apr 19, 2023
K242822 — ART-Plan+ (v.3.0.0) · Therapanacea Sas · Feb 25, 2025
K253091 — ART-Plan+ (v3.1.0) · Therapanacea Sas · Dec 23, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ December 22, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". TheraPanacea % Bhairavi Ajachandra QA/RA Manager 7 bis boulevard Bourdon Paris. 75004 FRANCE Re: K232479 Trade/Device Name: ART-Plan Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: November 20, 2023 Received: November 20, 2023 Dear Bhairavi Ajachandra: 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). 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 {1}------------------------------------------------ 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 the reporting 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 medical devices and radiation-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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K232479 Device Name ART-Plan #### Indications for Use (Describe) ART-Plan's indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available. ART-Plan is not intended for patients less than 18 years of age. The indicated users are trained medical professionals including, but not limited to, radiotherapists, radiation oncologists, medical physicists, dosimetrists and medical professionals involved in the radiation therapy process. The indicated use environments are, but not limited to, hospitals, clinics and any health facility involved in radiation therapy. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | <div> ❌ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92. #### Level of documentation: Enhanced #### Submitter's Name: TheraPanacea SAS #### Submitter's Address: 7 bis boulevard Bourdon 75004 Paris France Telephone: +33 9 62 52 78 19 #### Establishment Registration Number: 3019834893 #### Contact Person: Bhairavi Ajachandra Telephone: +33 (0) 620604982 #### Date Prepared: 10 Aug 2023 #### Below summaries the Device Classification Information regarding the TheraPanacea ART-Plan: #### Primary Product Code: | Regulation Number | Device | Device Class | Product Code | Classification Panel | |----------------------|------------------------------------------------------|-----------------|-----------------|-------------------------| | 892.5050 | Medical charged-particle radiation therapy system | Class II | MUJ | Radiology | #### Device Trade Name: ART-Plan #### Device Common Name: ART-Plan {4}------------------------------------------------ #### Intended Use: ART-Plan is a software intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists and radiation oncologists. The software consists of different applications, each used for specific purposes at a different phase of radiation treatment planning. ART-Plan offers the following tools to aid in the workflow of radiotherapy treatment: - Multi-modal visualization and rigid- and deformable registration of anatomical and . functional images such as CT, MR, PET-CT, 4D-CT, CBCT and synthetic-CT generated from CBCT - Display of fused and non-fused images to facilitate the comparison and delineation of image data by the user - Manual generation, modification and semi-automatic generation of contours for the ● regions of interest - Automatic generation of contours for organs at risk and healthy lymph nodes, based ● on medical practices, on medical images such as CT and MR images - Generation of synthetic-CT from MR images for supported anatomies - Generation of synthetic-CT from CBCT images for supported anatomies ● - Dose computation on CT and/or synthetic-CT images for external beam irradiation ● with photon beams - Assisted CBCT-based off-line adaptation decision-making for supported anatomies The device is intended to be used in a radiation therapy clinical setting, by trained professionals only. #### Indications for Use: ART-Plan's indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available. ART-Plan is not intended for patients less than 18 years of age. The indicated users are trained medical professionals includinq, but not limited to, radiotherapists, radiation oncologists, medical physicists, dosimetrists and medical professionals involved in the radiation therapy process. The indicated use environments include, but are not limited to, hospitals, clinics and any health facility involved in radiation therapy. {5}------------------------------------------------ #### Summary of Substantial Equivalence: The following predicate devices have been that the ART-Plan can claim equivalence with and these are detailed below in Table 1. Summary of Substantial Equivalence. #### General Comparison | | General Information | | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Property | Proposed Device ART-Plan v2.1.0 | Primary Predicate Ethos Treatment Management, 2.1; Ethos Treatment Planning, 1.1 | Reference device ART-Plan v1.10.1 | Reference device ECLIPSE WITH AAA | Reference device Eclipse Treatment Planning System | Comment | | Common Name | System, Planning, Radiation Therapy Treatment | accelerator, linear, medical | Radiological image processing software for radiation therapy | System, Planning, Radiation Therapy Treatment | System, Planning, Radiation Therapy Treatment | The proposed device shares the same common name "System, Planning, Radiation Therapy Treatment" with the primary predicate, especially Ethos Treatment Planning, 1.1 (that has "MUJ" as a product code in its 510(k) summary) and with some of the reference devices. | | Device Manufactur er | TheraPanacea SAS | Varian Medical Systems, Inc | TheraPanacea SAS | Varian Medical Systems (now Varian Medical Systems, Inc) | Varian Medical Systems, Inc | N/A | | 510k | N/A | K212294 | K230023 | K041403 | K102011 | N/A | | Device Classificatio n | II | II | II | II | II | N/A The proposed device, primary predicate and reference devices have identical device classification. | | Primary Product Code | MUJ | IYE, MUJ | QKB | MUJ | MUJ | The primary product code is MUJ for "System, Planning, Radiation Therapy Treatment" as it is a software used in the planning of radiotherapy treatment like the primary predicate, especially Ethos Treatment Planning, 1.1 (that has "MUJ" as a product code in its 510(k) summary) and some reference devices use it as their primary or secondary code | | Secondary Product Code | QKB, LLZ | LLZ, MUJ | | LHN | As secondary product code: - QKB (Radiological image processing software for radiation therapy) has been included as the software uses Al algorithms and is intended for radiation therapy. It is also the primary code of the reference device ART-Plan v1.10.1 of which ART-Plan 2.1.0 is an update; - LLZ (System, Image Processing, Radiological) has been included as the software is used in image processing and it is also the subsequent code of the reference device ART-Plan v1.10.1 of which ART-Plan 2.1.0 is an update. | | | Target Population | ART-Plan's indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available. | The patient target groups are the patients for whom radiation therapy is indicated. | ART-Plan's indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available. | Not stated | Any patients with malignant or benign diseases | The proposed device and the primary predicate have identical target populations. | | Environmen t | Hospital | Hospital | Hospital | Hospital | Hospital | The proposed device, primary predicate and reference devices have identical target environments. | | Intended Use/ Indication for Use | Intended Use ART-Plan is a software intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists and | Intended Use Ethos Treatment Management is used to manage and monitor radiation therapy treatment plans and sessions; it is intended to be used | Intended Use ART-Plan is a software for multi-modal visualization, contouring and processing of 3D images of cancer patients for whom | Intended Use The Varian Eclipse device is a treatment planning system used for diagnostic image analysis, contouring and segmentation, geometrical | Intended use Not available in the summary: Indication for use The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy | The intended use and indications for use of the proposed device, ART-Plan v2.1.0 and the primary predicate (especially Ethos Treatment Planning, 1.1) are similar as they are both softwares intended to be used in the planning of radiotherapy treatment¹: | | radiation oncologists. The software consists of different applications, each used for specific purposes at a different phase of radiation treatment planning. | with a treatment planning system. Ethos Treatment Planning is used to generate and modify radiation therapy treatment plans. | radiotherapy treatment has been prescribed. It allows the user to view, create and modify contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the organs at risk and healthy lymph nodes and to register combinations of anatomical and functional images. Contours and images require verifications, potential modifications, and subsequently the validation of a trained user with professional qualifications in anatomy and radiotherapy before their export to a Treatment Planning System. | planning, photon and electron dose calculation and plan review. | treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beamA, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm specifically indicated for planning proton treatment of neoplasms of the eye. | they allow multi-modal visualisation rigid- and deformable registration for the same modalities of images (CT, MR and PET) | | | ART-Plan offers the following tools to aid in the workflow of radiotherapy treatment: Multi-modal visualization and rigid- and deformable registration of anatomical and functional images such as CT, MR, PET-CT, 4D-CT, CBCT and synthetic-CT generated from CBCT Display of fused and non-fused images to facilitate the comparison and delineation of image data by the user Manual generation, modification and semi-automatic generation of contours for the regions of interest | Indications for Use Ethos Treatment Management is indicated for use in managing and monitoring treatment plans and sessions. Ethos Treatment Planning is indicated for use in generating and modifying radiation therapy treatment plans. | ART-Plan offers the following visualization, contouring and manipulation tools to aid in the preparation of radiotherapy treatment: | Indication for use The Varian Eclipse device is used to plan photon and electron radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1-50 MV, as well as Cobalt-60, and electron energies from 1-50 MeV. Eclipse will plan the 3D radiotherapy treatment approaches to combined modality plans, coplanar and non-coplanar fields, static and ARC fields, beam modifiers, and beam intensity modulators. Eclipse also includes tools for treatment preparation (diagnostic image and analysis, contouring and segmentation) and plan review. | | they allow displaying fused and non-fused images to facilitate the comparison and delineation of image data by the user they allow manual generation, modification and semi-automatic generation of contours for the regions of interest they allow automatic segmentation on medical images using AI algorithms they allow generation of synthetic-CT from CBCT images they allow dose computation on CT and/or synthetic-CT images for external beam irradiation with photon beams they allow assisted CBCT-based off-line adaptation decision-making for supported anatomies they allow the import, manipulation, visualisation, generation and the export of DICOM images The intended use for the proposed device has been adapted to provide a more specific description of the proposed device but does not represent a new intended use, except for the additional modality for the same claim as compared to the primary predicate as: | | | | | - Multi-modal visualization and rigid- and deformable registration of anatomical and functional images | | | | | {6}------------------------------------------------ 1 Information found on the previous 510(k) summaries, labelling and its manufacturer's (Varian Medical Systems, Inc) website. {7}------------------------------------------------ {8}------------------------------------------------ | Automatic generation of contours for organs at risk and healthy lymph nodes, based on medical practices, on medical images such as CT and MR images | such as CT, MR, PET-CT, 4D-CT and CBCT - Display of fused and non-fused images to facilitate the comparison and delineation of image data by the user - Manual modification and semi-automatic generation of contours for the regions of interest - Automatic generation of contours for organs at risk and healthy lymph nodes, based on medical practices, on medical images such as CT and MR images. - Generation of pseudo-CT for supported anatomies | - it can generate synthetic CT from CBCT and MR images whereas it is not possible with Ethos Treatment Planning, 1.1 to do so with MR images. This does not represent an additional claim as the technological characteristics are the same and it does not raise different questions of safety and effectiveness. Also, this feature is covered by the reference device ART-Plan v1.10.1, which is the previous version cleared of the proposed device ART-Plan v2.1.0. | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Generation of synthetic-CT from MR images for supported anatomies | The device is intended to be used in a radiation therapy clinical setting, by trained professionals only. | | | Generation of synthetic-CT from CBCT images for supported anatomies | | | | Dose computation on CT and/or synthetic-CT images for external beam irradiation with photon beams |…