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Reviewed 18 Aug 2026

Completeness Strong (72%)

ART-Plan

FDA

ART-Plan is an AI-based software platform developed by TheraPanacea to support radiotherapy treatment planning workflows. The platform provides authorized users with a set of software modules designed to assist in the preparation, assessment, and management of radiotherapy treatment planning activities using medical imaging data. ART-Plan operates through a user account system that provides access to functions based on predefined user rights and permissions. The system supports both Cloud and On-premise deployments. The software includes tools for image and plan import, organization, analysis, and processing of medical imaging data used during the radiotherapy planning process. Depending on the modules installed and licensed, ART-Plan supports activities such as contouring organs at risk or tumors, automated protocol-based treatment plan generation based on predicted class solution, and adaptive treatment assessment based on AI-generated synthetic-CT. The tasks are automated, can be performed simultaneously on multiple patients, and the results are exported to the Treatment Planning System for further review, editing and approval.

No papers to support — we monitor for new evidence.

Key Features

Autosegmentation
Image Enhancement
Image Registration
Plan Generation/Optimisation
Synthetic CT Generation
Workflow Automation

General Information

Product name

ART-Plan

Company

TheraPanacea

Workflow phase

Contouring, Imaging, Plan evaluation, Planning

Modality

CBCT, CT, MR, PET/CT

Treatment site

Abdomen, Brain/CNS, Breast, Extremities, Female pelvis, Head & neck, Male pelvis, Spine, Thorax

Exact structures

CT-based Structures Head & Neck: Brachial_Plex_(L/R), Brain, Brainstem, Cerebellum, Cochlea_(L/R), Common carotid artery (L/R), Esophagus, External carotid artery (L/R), External contours, External jugular vein(L/R), Eyeball_(L/R), Lens_Eye_(L/R), Glottic_Larynx, Internal carotid artery (L/R), Internal jugular vein (L/R), Lacrim_gland_(L/R), Larynx, Lips, Mandible, Mouth, Optic_chiasm, Optic_nerve_(L/R), Parotid_(L/R), Pharynx_Const_muscle, Pituitary_Gland, Spinal_Canal, Spinal_Cord, Submand_Gland_ (L/R), Supraglottic_Larynx, Thyroid_Gland, TM_Joint_(L/R), Trachea, Lymph Nodes: LN_Neck_IA, LN_Neck_IB_(L/R), LN_Neck_II_(L/R), LN_Neck_III_(L/R), LN_Neck_IVA_(L/R), LN_Neck_IVB_(L/R), LN_Neck_V_(L/R), LN_Neck_VIA, LN_Neck_VIB, LN_Neck_VIIA_(L/R), LN_Neck_VIIB_(L/R) Thorax, Breast & Abdomen: Aorta, Atrium_(L/R), Brachial_Plex_(L/R), Breast_(L/R), Bronchia_(L/R), Bronchial_Tree, Bronchus_(L/R), Cardiac_Aorta, Carina, Cauda Equina, Chestwall_(L/R), Coronary_Sinus, Distal_Circumflex_Coronary, Esophagus, Heart, Humerus_Head_(L/R), Kidney_(L/R), LAD_Coronary, L_Main_Coro_Art, Liver, Lung_(L/R), Pericardium, Proximal_Circumflex_Coronary, Pulmonary_Arter, Ribs 1-12_(L/R), Spinal_Canal, Spinal_Cord, Spleen, Stomach, Supraglottic_Larynx, Thyroid_Gland, Trachea, Vena_Cava_Inf, Vena_Cava_Sup, Ventri_(L/R), Ventri_L_Ant, Ventri_L_Api, Ventri_L_Inf, Ventri_L_Lat, Ventri_L_Sept, Lymph Nodes: LN_IMN_(L/R), LN_Interpec_(L/R), LN_Ax_L1_(L/R), LN_Ax_L2_(L/R), LN_Ax_L3_(L/R), LN_Ax_L4_(L/R) Male Pelvis: Anal_Canal, Bladder, Bowel_Bag, Cauda Equina, Duodenum, External contours, Femur_Head_(L/R), Illium_(L/R), Large_Bowel, Penile_Bulb, Prostate, Rectum, Sacrum, Seminal_Vesicle, Sigmoid_Colon, Small_Bowel, Spinal_Cord, VB_L4, VB_L5, Lymph Nodes: Ischio_Rectal_Fossae_Val, LN_Iliac_Ext_L_Val, LN_Inguinofem_L_Val, LN_Iliac_Int_L_Val, LN_Obturator_L_Val, Mesorectum_Val, Presacral_Abdo_LN_Val, Presacral_Pelvis_LN_Val, LN_Iliac_Ext_R_Val, LN_Inguinofem_R_Val, LN_Iliac_Int_R_Val, LN_Obturator_R_Val, Sphincter_Complex_Val, LN_Common_Iliac, LN_Lomboaortic, Female Pelvis: Anal_Canal, Bladder, Bowel_Bag, Cauda Equina, Duodenum, External contours, Femur_Head_(L/R), Ilium_(L/R), Large_Bowel, Parametrium, Rectum, Sacrum, Sigmoid_Colon, Small_Bowel, Spinal_Cord, Utero_Cervix, Vagina, VB_L4, VB_L5 Lymph Nodes: LN_Common_Iliac, LN_Iliac_(L/R), LN_Ingui_Gyn_(L/R), LN_Lomboaortic, LN_Presacral, Ischio_Rectal_Fossae_Val, LN_Iliac_Ext_L_Val, LN_Inguinofem_L_Val, LN_Iliac_Int_L_Val, LN_Obturator_L_Val, Mesorectum_Val, Presacral_Abdo_LN_Val, Presacral_Pelvis_LN_Val, LN_Iliac_Ext_R_Val, LN_Inguinofem_R_Val, LN_Iliac_Int_R_Val, LN_Obturator_R_Val, Sphincter_Complex_Val, MR-based Structures Brain: MR T1 Brain, Cerebellum_Ant, Cerebellum_Post, Cochlea_(L/R), Cornea_(L/R), Hippocampus_(L/R), Hypothalamus_(L/R), Lacrim_Gland_(L/R), Lens_Eye(L/R), Medulla_Oblong, Midbrain, Opt_Chiasm, Optic_nerve (L/R), Pituitary_Gland, Pons, Retina_(L/R), Spinal_Cord, VSCC_(L/R), Male Pelvis: MR T2 Elekta Unity Anal_Canal, Bladder, Bony_Pelvis_(L/R), Femur_Head_(L/R), Penile_Bulb, Prostate, Rectum, Sacrum, Seminal_Vesicle, Colon_Sigmoid, Small Bowel, Male Pelvis & Abdomen TrueFisp: MR T1 Anal_Canal, Bladder, Femur_Head_(L/R), Penile_Bulb, Rectum, Sigmoid_Colon, Aorta_Abdomen, Duodenum, Kidney_(L/R), Large_Bowel, Liver, Pancreas, Stomach, Vena Cava_Inf, Prostate, Seminal_Vesicle Brachytherapy: MR T1 Bladder, Rectum, Sigmoid_Colon, Small_bowel Tumors: MR T1 Gadolinium Brain Metastasis Glioblastoma

Regulatory Information

CE Certification

Pathway:

MDR

Class:

Class IIb

Verified by Health AI Register

FDA Certification

Pathway:

510(k) cleared

Class:

Class II

FDA Number:

K253091

View FDA record

Verified by Health AI Register

Other certifications

UKCA, SFDA - Saudi, Other

Evidence & Research

No research papers or evidence on file yet.

The registry monitors publications for new evidence.

Technical Specifications

Prerequisites

None, Specific hardware required

Defined prerequisite(s)

Cloud Instance doesn't require specific hardware

Treatment technique

Not applicable, VMAT

Delivery system

Linac

Workflow features

Adaptive RT, IGRT

Patient population age

Adult

Input

3D, Multi-slice, CT, MR, PET, CBCT, RTSTRUCT, RTPLAN, RTDOSE, DICOM Q&R, Manual Input,

Input format

DICOM, RT Dose, RT Plan, RT STRUCT

Output

Segmented structures, Synthetic CT, Arcs, Machine info

Output format

DICOM, DICOM Registration objects, RT Plan, RT STRUCT

Integration

Stand-alone application, Web-based application

Integration method

No external integration possible

API documentation availability

Not applicable

API documentation, if publicly available

Private API is Works-in-Progress

TPS compatibility

Brainlab Elements, Eclipse, Monaco, Pinnacle3, RayStation

Deployment

Cloud-based, Hybrid solution, Locally on dedicated hardware

Trigger for AI functionality

Automatically, after data acquisition, On demand, triggered by a user through e.g. a button click, image upload

Processing time

Not specified

Retraining locally

Not applicable

Claims

The auto-segmentation module complies with multiple guidelines based on the anatomy - the list includes, but is not restricted to, RTOG, ESTRO, Grégoire et al 2014, Valentini et al 2016, Gay et al 2012, Mir et al 2020 etc. Processing times vary per use: Auto-Seg ~ 2-5 mins Auto-Plan ~ 10 mins Auto-Adapt ~ 15 mins

Known limitations

There are several limitations depending on the module being used. Auto-Segmentation is restricted to patients beyond 18 - i.e. no pediatric. CBCT to sCT generation is restricted to Male Pelvis, Thorax/Breast, Head & Neck.

Market Presence

On market since

09-2019

AI Platforms

Resellers

Advanced Technology company, Avanço, CANBERRA PACKARD BULGARIA, Device Technologies, Dtect, ELSE Solutions, Experia, GREEN SOUND Kft, HDX, Human Bytes, Intramarket Medical Technologies, Karvonis , MBA Incorporado S.L., ME3SS/ICLOUD, OSL and importator Compliance Solutions, Radontek LTD, Star Product Limited, Stiga, Vapos Electronics S.C.

Countries present

Paying clinical customers

250

Research/test users

Pricing Information

Pricing model

Pay-per-use, Subscription

Based on

Per Linac

Source: Vendor | First published: Apr 3, 2026 | Last updated: Aug 18, 2026