Radiological Image Processing Software For Radiation Therapy
Regulation 892.2050
10510(k)s in 12 months (49 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QKB
| Company | 510(k)s | Recalls |
|---|---|---|
| Mim Software, Inc. | 7 | 0 |
| Radformation, Inc. | 6 | 0 |
| Ever Fortune.Ai, Co., Ltd. | 3 | 0 |
| Manteia Technologies Co., Ltd. | 3 | 0 |
| Siemens Medical Solutions U.S.A. | 3 | 0 |
| Therapanacea | 3 | 0 |
| Vysioneer, Inc. | 3 | 0 |
| MVision AI | 2 | 0 |
| Oncosoft. Co., Ltd. | 2 | 0 |
| Siemens Healthcare GmbH | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2026 | K262452 | AutoContour (RADAC V6) Radformation, Inc. | QKB |
| Jul 10, 2026 | K261306 | AI Contouring (VA10A) Varian Medical Systems | QKB |
| Jul 2, 2026 | K260528 | OncoStudio Oncosoft. Inc.,, KR | QKB |
| Apr 10, 2026 | K252548 | AI-Rad Companion Organs RT Siemens Healthcare GmbH, DE | QKB |
| Apr 10, 2026 | K252190 | DeepBT Detector-Plus Aitewan Biomedical Technology, Inc., TW | QKB |
| Mar 27, 2026 | K253270 | Contour ProtégéAI+ Mim Software, Inc. | QKB |
| Mar 19, 2026 | K260509 | AutoContour (RADAC V5) Radformation, Inc. | QKB |
| Jan 28, 2026 | K251306 | Seg Pro V3 (RT-300) Ever Fortune.Ai, Co., Ltd., TW | QKB |
| Jan 23, 2026 | K251351 | AccuContour 4.0 Manteia Technologies Co., Ltd., CN | QKB |
| Dec 5, 2025 | K250780 | ARTAssistant Manteia Technologies Co., Ltd., CN | QKB |
| May 28, 2025 | K250427 | TAIMedImg DeepMets Taiwan Medical Imaging Co., Ltd., TW | QKB |
| Apr 1, 2025 | K242925 | MR Contour DL GE Healthcare | QKB |
| Mar 27, 2025 | K242745 | AI-Rad Companion Organs RT Siemens Healthcare GmbH, DE | QKB |
| Feb 24, 2025 | K242994 | OncoStudio (OS-01) Oncosoft. Co., Ltd., KR | QKB |
| Feb 3, 2025 | K250035 | Contour ProtégéAI+ Mim Software, Inc. | QKB |
| Dec 9, 2024 | K242729 | AutoContour (Model RADAC V4) Radformation, Inc. | QKB |
| Oct 18, 2024 | K241490 | Contour+ (MVision AI Segmentation) Mvision AI OY, FI | QKB |
| Oct 9, 2024 | K241837 | Limbus Contour Limbus Ai, Inc., CA | QKB |
| May 7, 2024 | K232928 | DeepContour (V1.0) Wisdom Technologies., Inc., CN | QKB |
| Apr 3, 2024 | K232899 | AI-Rad Companion Organs RT Siemens Medical Solutions U.S.A. | QKB |
| Feb 13, 2024 | K231855 | QOCA® image Smart RT Contouring System Quanta Computer, Inc., TW | QKB |
| Nov 8, 2023 | K231765 | Contour ProtégéAI Mim Software, Inc. | QKB |
| Sep 25, 2023 | K231928 | EFAI RTSUITE CT HCAP-Segmentation System Ever Fortune.Ai, Co., Ltd., TW | QKB |
| May 4, 2023 | K230082 | Auto Segmentation Ge Medical Systems, LLC | QKB |
| Apr 19, 2023 | K230023 | ART-Plan Therapanacea Sas, FR | QKB |
| Apr 14, 2023 | K230685 | AutoContour Model RADAC V3 Radformation, Inc. | QKB |
| Apr 6, 2023 | K223774 | Contour ProtégéAI Mim Software, Inc. | QKB |
| Mar 9, 2023 | K221706 | AccuContour Manteia Technologies Co., Ltd., CN | QKB |
| Nov 10, 2022 | K220408 | AVIEW RT ACS Coreline Soft Co., Ltd., KR | QKB |
| Oct 14, 2022 | K221305 | AI-Rad Companion Organs RT Siemens Medical Solutions USA, Inc. | QKB |
| Aug 24, 2022 | K220598 | AutoContour Model RADAC V2 Radformation, Inc. | QKB |
| Jun 17, 2022 | K220813 | ART-PLAN Therapanacea, FR | QKB |
| May 3, 2022 | K212915 | MVision AI Segmentation MVision AI, FI | QKB |
| Apr 28, 2022 | K220264 | EFAI RTSuite CT HN-Segmentation System Ever Fortune.Ai, Co., Ltd., TW | QKB |
| Feb 3, 2022 | K213976 | Contour ProtégéAI Mim Software, Inc. | QKB |
| Dec 16, 2021 | K213628 | VBrain Vysioneer, Inc. | QKB |
| Dec 15, 2021 | K213155 | RT-Mind-AI Medmind Technology Co., Ltd., CN | QKB |
| Oct 25, 2021 | K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) Elekta Solutions AB, SE | QKB |
| Oct 20, 2021 | K210632 | Contour ProtegeAI Mim Software, Inc. | QKB |
| Oct 12, 2021 | K212116 | VBrain-OAR Vysioneer, Inc. | QKB |
| Apr 20, 2021 | K203610 | Automatic Anatomy Recognition (AAR) Quantitative Radiology Solutions, LLC | QKB |
| Apr 2, 2021 | K202928 | DV. Target Deepvoxel, Inc. | QKB |
| Mar 19, 2021 | K203235 | VBrain Vysioneer, Inc. | QKB |
| Jan 14, 2021 | K202700 | ART-Plan Therapanacea, FR | QKB |
| Nov 6, 2020 | K193562 | AI-Rad Companion Organs RT Siemens Medical Solutions USA, Inc. | QKB |
| Oct 30, 2020 | K200323 | AutoContour Radformation, Inc. | QKB |
| Jul 2, 2020 | K193252 | Contour ProtegeAI Mim Software, Inc. | QKB |
| Feb 28, 2020 | K191928 | AccuContour Xiamen Manteia Technology , Ltd., CN | QKB |
| Jul 10, 2018 | K181572 | Workflow Box Mirada Medical, Ltd., GB | QKB |
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