Radiological Image Processing Software For Radiation Therapy
FDA product code QKB · Class II (moderate risk) · 21 CFR 892.2050 · Radiology
To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.
49510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Mim Software, Inc. 7
- Radformation, Inc. 6
- Therapanacea Sas 3
- Vysioneer, Inc. 3
- Ever Fortune.Ai, Co., Ltd. 3
- Manteia Technologies Co., Ltd. 3
- Oncosoft. Inc., 2
- Siemens Medical Solutions USA, Inc. 2
- Siemens Healthcare GmbH 2
- Mvision AI OY 2
- Medmind Technology Co., Ltd. 1
- Varian Medical Systems, Inc. 1
- Siemens Medical Solutions U.S.A. 1
- Quanta Computer, Inc. 1
- GE Medical Systems, LLC 1
- Coreline Soft Co., Ltd. 1
- Mirada Medical, Ltd. 1
- Elekta Solutions AB 1
- Quantitative Radiology Solutions, LLC 1
- Deepvoxel, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262452 | AutoContour (RADAC V6)QKB · Special | Radformation, Inc. | 08/14/2026SE |
| K261306 | AI Contouring (VA10A)QKB · Traditional | Varian Medical Systems | 07/10/2026SE |
| K260528 | OncoStudioQKB · Traditional | Oncosoft. Inc., | 07/02/2026SE |
| K252548 | AI-Rad Companion Organs RTQKB · Traditional | Siemens Healthcare GmbH | 04/10/2026SE |
| K252190 | DeepBT Detector-PlusQKB · Traditional | Aitewan Biomedical Technology, Inc. | 04/10/2026SE |
| K253270 | Contour ProtégéAI+QKB · Traditional | Mim Software, Inc. | 03/27/2026SE |
| K260509 | AutoContour (RADAC V5)QKB · Special | Radformation, Inc. | 03/19/2026SE |
| K251306 | Seg Pro V3 (RT-300)QKB · Traditional | Ever Fortune.Ai, Co., Ltd. | 01/28/2026SE |
| K251351 | AccuContour 4.0QKB · Traditional | Manteia Technologies Co., Ltd. | 01/23/2026SE |
| K250780 | ARTAssistantQKB · Traditional | Manteia Technologies Co., Ltd. | 12/05/2025SE |
| K250427 | TAIMedImg DeepMetsQKB · Traditional | Taiwan Medical Imaging Co., Ltd. | 05/28/2025SE |
| K242925 | MR Contour DLQKB · Traditional | GE Healthcare | 04/01/2025SE |
| K242745 | AI-Rad Companion Organs RTQKB · Traditional | Siemens Healthcare GmbH | 03/27/2025SE |
| K242994 | OncoStudio (OS-01)QKB · Traditional | Oncosoft. Co., Ltd. | 02/24/2025SE |
| K250035 | Contour ProtégéAI+QKB · Special | Mim Software, Inc. | 02/03/2025SE |
| K242729 | AutoContour (Model RADAC V4)QKB · Traditional | Radformation, Inc. | 12/09/2024SE |
| K241490 | Contour+ (MVision AI Segmentation)QKB · Traditional | Mvision AI OY | 10/18/2024SE |
| K241837 | Limbus ContourQKB · Traditional | Limbus Ai, Inc. | 10/09/2024SE |
| K232928 | DeepContour (V1.0)QKB · Traditional | Wisdom Technologies., Inc. | 05/07/2024SE |
| K232899 | AI-Rad Companion Organs RTQKB · Traditional | Siemens Medical Solutions U.S.A. | 04/03/2024SE |
| K231855 | QOCA® image Smart RT Contouring SystemQKB · Traditional | Quanta Computer, Inc. | 02/13/2024SE |
| K231765 | Contour ProtégéAIQKB · Special | Mim Software, Inc. | 11/08/2023SE |
| K231928 | EFAI RTSUITE CT HCAP-Segmentation SystemQKB · Special | Ever Fortune.Ai, Co., Ltd. | 09/25/2023SE |
| K230082 | Auto SegmentationQKB · Traditional | Ge Medical Systems, LLC | 05/04/2023SE |
| K230023 | ART-PlanQKB · Special | Therapanacea Sas | 04/19/2023SE |
| K230685 | AutoContour Model RADAC V3QKB · Special | Radformation, Inc. | 04/14/2023SE |
| K223774 | Contour ProtégéAIQKB · Traditional | Mim Software, Inc. | 04/06/2023SE |
| K221706 | AccuContourQKB · Traditional | Manteia Technologies Co., Ltd. | 03/09/2023SE |
| K220408 | Aview RT AcsQKB · Traditional | Coreline Soft Co., Ltd. | 11/10/2022SE |
| K221305 | AI-Rad Companion Organs RTQKB · Traditional | Siemens Medical Solutions USA, Inc. | 10/14/2022SE |
| K220598 | AutoContour Model RADAC V2QKB · Traditional | Radformation, Inc. | 08/24/2022SE |
| K220813 | Art-PlanQKB · Traditional | Therapanacea | 06/17/2022SE |
| K212915 | MVision AI SegmentationQKB · Traditional | MVision AI | 05/03/2022SE |
| K220264 | EFAI RTSuite CT HN-Segmentation SystemQKB · Traditional | Ever Fortune.Ai, Co., Ltd. | 04/28/2022SE |
| K213976 | Contour ProtégéAIQKB · Special | Mim Software, Inc. | 02/03/2022SE |
| K213628 | VBrainQKB · Special | Vysioneer, Inc. | 12/16/2021SE |
| K213155 | RT-Mind-AIQKB · Traditional | Medmind Technology Co., Ltd. | 12/15/2021SE |
| K212218 | Advanced Algorithms for Treatment Management Applications (AATMA)QKB · Traditional | Elekta Solutions AB | 10/25/2021SE |
| K210632 | Contour ProtegeAIQKB · Traditional | Mim Software, Inc. | 10/20/2021SE |
| K212116 | VBrain-OARQKB · Traditional | Vysioneer, Inc. | 10/12/2021SE |
| K203610 | Automatic Anatomy Recognition (AAR)QKB · Traditional | Quantitative Radiology Solutions, LLC | 04/20/2021SE |
| K202928 | DV. TargetQKB · Traditional | Deepvoxel, Inc. | 04/02/2021SE |
| K203235 | VBrainQKB · Traditional | Vysioneer, Inc. | 03/19/2021SE |
| K202700 | ART-PlanQKB · Traditional | Therapanacea | 01/14/2021SE |
| K193562 | AI-Rad Companion Organs RTQKB · Traditional | Siemens Medical Solutions USA, Inc. | 11/06/2020SE |
| K200323 | AutoContourQKB · Traditional | Radformation, Inc. | 10/30/2020SE |
| K193252 | Contour ProtegeAIQKB · Traditional | Mim Software, Inc. | 07/02/2020SE |
| K191928 | AccuContourQKB · Traditional | Xiamen Manteia Technology , Ltd. | 02/28/2020SE |
| K181572 | Workflow BoxQKB · Traditional | Mirada Medical, Ltd. | 07/10/2018SE |