QKB
48 FDA 510(k) clearances · Product code
147 daysmedian time to decision
269 days90th percentile
48clearances measured
FDA profile
- Official device name
- Radiological Image Processing Software For Radiation Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Medical specialty
- Radiology
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| AI Contouring (VA10A) (K261306) | Varian Medical Systems | 2026-07-10 |
| OncoStudio (K260528) | Oncosoft. Inc., | 2026-07-02 |
| AI-Rad Companion Organs RT (K252548) | Siemens Healthcare GmbH | 2026-04-10 |
| DeepBT Detector-Plus (K252190) | Aitewan Biomedical Technology, Inc. | 2026-04-10 |
| Contour ProtégéAI+ (K253270) | Mim Software, Inc. | 2026-03-27 |
| AutoContour (RADAC V5) (K260509) | Radformation, Inc. | 2026-03-19 |
| Seg Pro V3 (RT-300) (K251306) | Ever Fortune.Ai, Co., Ltd. | 2026-01-28 |
| AccuContour 4.0 (K251351) | Manteia Technologies Co., Ltd. | 2026-01-23 |
| ARTAssistant (K250780) | Manteia Technologies Co., Ltd. | 2025-12-05 |
| TAIMedImg DeepMets (K250427) | Taiwan Medical Imaging Co., Ltd. | 2025-05-28 |
| MR Contour DL (K242925) | GE Healthcare | 2025-04-01 |
| AI-Rad Companion Organs RT (K242745) | Siemens Healthcare GmbH | 2025-03-27 |
| OncoStudio (OS-01) (K242994) | Oncosoft. Co., Ltd. | 2025-02-24 |
| Contour ProtégéAI+ (K250035) | Mim Software, Inc. | 2025-02-03 |
| AutoContour (Model RADAC V4) (K242729) | Radformation, Inc. | 2024-12-09 |
| Contour+ (MVision AI Segmentation) (K241490) | Mvision AI OY | 2024-10-18 |
| Limbus Contour (K241837) | Limbus Ai, Inc. | 2024-10-09 |
| DeepContour (V1.0) (K232928) | Wisdom Technologies., Inc. | 2024-05-07 |
| AI-Rad Companion Organs RT (K232899) | Siemens Medical Solutions U.S.A. | 2024-04-03 |
| QOCA® image Smart RT Contouring System (K231855) | Quanta Computer, Inc. | 2024-02-13 |
| Contour ProtégéAI (K231765) | Mim Software, Inc. | 2023-11-08 |
| EFAI RTSUITE CT HCAP-Segmentation System (K231928) | Ever Fortune.Ai, Co., Ltd. | 2023-09-25 |
| Auto Segmentation (K230082) | Ge Medical Systems, LLC | 2023-05-04 |
| ART-Plan (K230023) | Therapanacea Sas | 2023-04-19 |
| AutoContour Model RADAC V3 (K230685) | Radformation, Inc. | 2023-04-14 |
| Contour ProtégéAI (K223774) | Mim Software, Inc. | 2023-04-06 |
| AccuContour (K221706) | Manteia Technologies Co., Ltd. | 2023-03-09 |
| AVIEW RT ACS (K220408) | Coreline Soft Co., Ltd. | 2022-11-10 |
| AI-Rad Companion Organs RT (K221305) | Siemens Medical Solutions USA, Inc. | 2022-10-14 |
| AutoContour Model RADAC V2 (K220598) | Radformation, Inc. | 2022-08-24 |
| ART-PLAN (K220813) | Therapanacea | 2022-06-17 |
| MVision AI Segmentation (K212915) | MVision AI | 2022-05-03 |
| EFAI RTSuite CT HN-Segmentation System (K220264) | Ever Fortune.Ai, Co., Ltd. | 2022-04-28 |
| Contour ProtégéAI (K213976) | Mim Software, Inc. | 2022-02-03 |
| VBrain (K213628) | Vysioneer, Inc. | 2021-12-16 |
| RT-Mind-AI (K213155) | Medmind Technology Co., Ltd. | 2021-12-15 |
| Advanced Algorithms for Treatment Management Applications (AATMA) (K212218) | Elekta Solutions AB | 2021-10-25 |
| Contour ProtegeAI (K210632) | Mim Software, Inc. | 2021-10-20 |
| VBrain-OAR (K212116) | Vysioneer, Inc. | 2021-10-12 |
| Automatic Anatomy Recognition (AAR) (K203610) | Quantitative Radiology Solutions, LLC | 2021-04-20 |
| DV. Target (K202928) | Deepvoxel, Inc. | 2021-04-02 |
| VBrain (K203235) | Vysioneer, Inc. | 2021-03-19 |
| ART-Plan (K202700) | Therapanacea | 2021-01-14 |
| AI-Rad Companion Organs RT (K193562) | Siemens Medical Solutions USA, Inc. | 2020-11-06 |
| AutoContour (K200323) | Radformation, Inc. | 2020-10-30 |
| Contour ProtegeAI (K193252) | Mim Software, Inc. | 2020-07-02 |
| AccuContour (K191928) | Xiamen Manteia Technology , Ltd. | 2020-02-28 |
| Workflow Box (K181572) | Mirada Medical, Ltd. | 2018-07-10 |
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