Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QKB — Predicate Candidate Screening
48 FDA 510(k) clearances under this product code; the 50 most recent screened below.
147 daysmedian FDA review time
269 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261306 | AI Contouring (VA10A) | Varian Medical Systems | 2026-07-10 | 81 | 0 |
| K260528 | OncoStudio | Oncosoft. Inc., | 2026-07-02 | 135 | 0 |
| K252548 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2026-04-10 | 240 | 0 |
| K252190 | DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. | 2026-04-10 | 270 | 0 |
| K253270 | Contour ProtégéAI+ | Mim Software, Inc. | 2026-03-27 | 179 | 0 |
| K260509 | AutoContour (RADAC V5) | Radformation, Inc. | 2026-03-19 | 30 | 0 |
| K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | 2026-01-28 | 275 | 0 |
| K251351 | AccuContour 4.0 | Manteia Technologies Co., Ltd. | 2026-01-23 | 268 | 0 |
| K250780 | ARTAssistant | Manteia Technologies Co., Ltd. | 2025-12-05 | 266 | 0 |
| K250427 | TAIMedImg DeepMets | Taiwan Medical Imaging Co., Ltd. | 2025-05-28 | 103 | 0 |
| K242925 | MR Contour DL | GE Healthcare | 2025-04-01 | 189 | 0 |
| K242745 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2025-03-27 | 197 | 0 |
| K242994 | OncoStudio (OS-01) | Oncosoft. Co., Ltd. | 2025-02-24 | 151 | 0 |
| K250035 | Contour ProtégéAI+ | Mim Software, Inc. | 2025-02-03 | 27 | 0 |
| K242729 | AutoContour (Model RADAC V4) | Radformation, Inc. | 2024-12-09 | 90 | 0 |
| K241490 | Contour+ (MVision AI Segmentation) | Mvision AI OY | 2024-10-18 | 147 | 0 |
| K241837 | Limbus Contour | Limbus Ai, Inc. | 2024-10-09 | 106 | 0 |
| K232928 | DeepContour (V1.0) | Wisdom Technologies., Inc. | 2024-05-07 | 230 | 0 |
| K232899 | AI-Rad Companion Organs RT | Siemens Medical Solutions U.S.A. | 2024-04-03 | 198 | 0 |
| K231855 | QOCA® image Smart RT Contouring System | Quanta Computer, Inc. | 2024-02-13 | 235 | 0 |
| K231765 | Contour ProtégéAI | Mim Software, Inc. | 2023-11-08 | 145 | 0 |
| K231928 | EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.Ai, Co., Ltd. | 2023-09-25 | 87 | 0 |
| K230082 | Auto Segmentation | Ge Medical Systems, LLC | 2023-05-04 | 113 | 0 |
| K230023 | ART-Plan | Therapanacea Sas | 2023-04-19 | 105 | 0 |
| K230685 | AutoContour Model RADAC V3 | Radformation, Inc. | 2023-04-14 | 32 | 0 |
| K223774 | Contour ProtégéAI | Mim Software, Inc. | 2023-04-06 | 111 | 0 |
| K221706 | AccuContour | Manteia Technologies Co., Ltd. | 2023-03-09 | 269 | 0 |
| K220408 | AVIEW RT ACS | Coreline Soft Co., Ltd. | 2022-11-10 | 269 | 0 |
| K221305 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | 2022-10-14 | 162 | 0 |
| K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | 2022-08-24 | 175 | 0 |
| K220813 | ART-PLAN | Therapanacea | 2022-06-17 | 88 | 0 |
| K212915 | MVision AI Segmentation | MVision AI | 2022-05-03 | 232 | 0 |
| K220264 | EFAI RTSuite CT HN-Segmentation System | Ever Fortune.Ai, Co., Ltd. | 2022-04-28 | 87 | 0 |
| K213976 | Contour ProtégéAI | Mim Software, Inc. | 2022-02-03 | 45 | 0 |
| K213628 | VBrain | Vysioneer, Inc. | 2021-12-16 | 29 | 0 |
| K213155 | RT-Mind-AI | Medmind Technology Co., Ltd. | 2021-12-15 | 78 | 0 |
| K212218 | Advanced Algorithms for Treatment Management Applications (A | Elekta Solutions AB | 2021-10-25 | 101 | 0 |
| K210632 | Contour ProtegeAI | Mim Software, Inc. | 2021-10-20 | 231 | 0 |
| K212116 | VBrain-OAR | Vysioneer, Inc. | 2021-10-12 | 97 | 0 |
| K203610 | Automatic Anatomy Recognition (AAR) | Quantitative Radiology Solutions, LLC | 2021-04-20 | 131 | 0 |
| K202928 | DV. Target | Deepvoxel, Inc. | 2021-04-02 | 185 | 0 |
| K203235 | VBrain | Vysioneer, Inc. | 2021-03-19 | 136 | 0 |
| K202700 | ART-Plan | Therapanacea | 2021-01-14 | 120 | 0 |
| K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | 2020-11-06 | 319 | 0 |
| K200323 | AutoContour | Radformation, Inc. | 2020-10-30 | 263 | 0 |
| K193252 | Contour ProtegeAI | Mim Software, Inc. | 2020-07-02 | 220 | 0 |
| K191928 | AccuContour | Xiamen Manteia Technology , Ltd. | 2020-02-28 | 224 | 0 |
| K181572 | Workflow Box | Mirada Medical, Ltd. | 2018-07-10 | 26 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda