FDA Product Code
FDA Product Code QKB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2050
510(k) Clearances — 49 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262452 | AutoContour (RADAC V6) | Radformation, Inc. | 2026-08-14 | Special | PDF ↗ |
| K261306 | AI Contouring (VA10A) | Varian Medical Systems | 2026-07-10 | Traditional | PDF ↗ |
| K260528 | OncoStudio | Oncosoft. Inc., | 2026-07-02 | Traditional | PDF ↗ |
| K252190 | DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. | 2026-04-10 | Traditional | PDF ↗ |
| K252548 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2026-04-10 | Traditional | PDF ↗ |
| K253270 | Contour ProtégéAI+ | Mim Software, Inc. | 2026-03-27 | Traditional | PDF ↗ |
| K260509 | AutoContour (RADAC V5) | Radformation, Inc. | 2026-03-19 | Special | PDF ↗ |
| K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | 2026-01-28 | Traditional | PDF ↗ |
| K251351 | AccuContour 4.0 | Manteia Technologies Co., Ltd. | 2026-01-23 | Traditional | PDF ↗ |
| K250780 | ARTAssistant | Manteia Technologies Co., Ltd. | 2025-12-05 | Traditional | PDF ↗ |
| K250427 | TAIMedImg DeepMets | Taiwan Medical Imaging Co., Ltd. | 2025-05-28 | Traditional | PDF ↗ |
| K242925 | MR Contour DL | GE Healthcare | 2025-04-01 | Traditional | PDF ↗ |
| K242745 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2025-03-27 | Traditional | PDF ↗ |
| K242994 | OncoStudio (OS-01) | Oncosoft. Co., Ltd. | 2025-02-24 | Traditional | PDF ↗ |
| K250035 | Contour ProtégéAI+ | Mim Software, Inc. | 2025-02-03 | Special | PDF ↗ |
| K242729 | AutoContour (Model RADAC V4) | Radformation, Inc. | 2024-12-09 | Traditional | PDF ↗ |
| K241490 | Contour+ (MVision AI Segmentation) | Mvision AI OY | 2024-10-18 | Traditional | PDF ↗ |
| K241837 | Limbus Contour | Limbus Ai, Inc. | 2024-10-09 | Traditional | PDF ↗ |
| K232928 | DeepContour (V1.0) | Wisdom Technologies., Inc. | 2024-05-07 | Traditional | PDF ↗ |
| K232899 | AI-Rad Companion Organs RT | Siemens Medical Solutions U.S.A. | 2024-04-03 | Traditional | PDF ↗ |
| K231855 | QOCA® image Smart RT Contouring System | Quanta Computer, Inc. | 2024-02-13 | Traditional | PDF ↗ |
| K231765 | Contour ProtégéAI | Mim Software, Inc. | 2023-11-08 | Special | PDF ↗ |
| K231928 | EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.Ai, Co., Ltd. | 2023-09-25 | Special | PDF ↗ |
| K230082 | Auto Segmentation | Ge Medical Systems, LLC | 2023-05-04 | Traditional | PDF ↗ |
| K230023 | ART-Plan | Therapanacea Sas | 2023-04-19 | Special | PDF ↗ |
| K230685 | AutoContour Model RADAC V3 | Radformation, Inc. | 2023-04-14 | Special | PDF ↗ |
| K223774 | Contour ProtégéAI | Mim Software, Inc. | 2023-04-06 | Traditional | PDF ↗ |
| K221706 | AccuContour | Manteia Technologies Co., Ltd. | 2023-03-09 | Traditional | PDF ↗ |
| K220408 | AVIEW RT ACS | Coreline Soft Co., Ltd. | 2022-11-10 | Traditional | PDF ↗ |
| K221305 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | 2022-10-14 | Traditional | PDF ↗ |
| K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | 2022-08-24 | Traditional | PDF ↗ |
| K220813 | ART-PLAN | Therapanacea | 2022-06-17 | Traditional | PDF ↗ |
| K212915 | MVision AI Segmentation | MVision AI | 2022-05-03 | Traditional | PDF ↗ |
| K220264 | EFAI RTSuite CT HN-Segmentation System | Ever Fortune.Ai, Co., Ltd. | 2022-04-28 | Traditional | PDF ↗ |
| K213976 | Contour ProtégéAI | Mim Software, Inc. | 2022-02-03 | Special | PDF ↗ |
| K213628 | VBrain | Vysioneer, Inc. | 2021-12-16 | Special | PDF ↗ |
| K213155 | RT-Mind-AI | Medmind Technology Co., Ltd. | 2021-12-15 | Traditional | PDF ↗ |
| K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) | Elekta Solutions AB | 2021-10-25 | Traditional | PDF ↗ |
| K210632 | Contour ProtegeAI | Mim Software, Inc. | 2021-10-20 | Traditional | PDF ↗ |
| K212116 | VBrain-OAR | Vysioneer, Inc. | 2021-10-12 | Traditional | PDF ↗ |
| K203610 | Automatic Anatomy Recognition (AAR) | Quantitative Radiology Solutions, LLC | 2021-04-20 | Traditional | PDF ↗ |
| K202928 | DV. Target | Deepvoxel, Inc. | 2021-04-02 | Traditional | PDF ↗ |
| K203235 | VBrain | Vysioneer, Inc. | 2021-03-19 | Traditional | PDF ↗ |
| K202700 | ART-Plan | Therapanacea | 2021-01-14 | Traditional | PDF ↗ |
| K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | 2020-11-06 | Traditional | PDF ↗ |
| K200323 | AutoContour | Radformation, Inc. | 2020-10-30 | Traditional | PDF ↗ |
| K193252 | Contour ProtegeAI | Mim Software, Inc. | 2020-07-02 | Traditional | PDF ↗ |
| K191928 | AccuContour | Xiamen Manteia Technology , Ltd. | 2020-02-28 | Traditional | PDF ↗ |
| K181572 | Workflow Box | Mirada Medical, Ltd. | 2018-07-10 | Traditional | PDF ↗ |
Product code QKB · Class II · Radiology. Data: openFDA.