Contour ProtégéAI
FDA 510(k) clearance K213976 · decided 2022-02-03
Clearance details
- K-number
- K213976
- Device name
- Contour ProtégéAI
- Applicant
- Mim Software, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-20
- Decision date
- 2022-02-03
- Days to decision
- 45 days
- Clearance type
- Special
- Product code
- QKB
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.