Rayvolve
FDA 510(k) clearance K260378 · decided 2026-05-12
Clearance details
- K-number
- K260378
- Device name
- Rayvolve
- Applicant
- AZmed
- Decision
- Substantially Equivalent
- Date received
- 2026-02-05
- Decision date
- 2026-05-12
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- QBS
- Device class
- 2
- Regulation number
- 892.2090
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Paris, FR
- 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 |
|---|---|---|
| TechCare Trauma (K242171) | Milvue | 2025-01-17 |
| icobrain aria (K240712) | Icometrix NV | 2024-11-07 |
| Rayvolve (K240845) | Azmed Sas | 2024-07-17 |
| Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite (K223491) | Ge Medical Systems, LLC | 2023-05-25 |
| BoneView (K222176) | Gleamer | 2023-03-02 |
| Rayvolve (K220164) | Azmed Sas | 2022-06-02 |
| BoneView (K212365) | Gleamer | 2022-03-01 |
| FractureDetect (FX) (K193417) | Imagen Technologies, Inc. | 2020-07-30 |
| OsteoDetect (DEN180005) | Imagen Technologies, Inc. | 2018-05-24 |
Recalls involving this device
No recalls on record reference this clearance.