Rayvolve 2
Rayvolve 2 is a X-ray image interpretive software (FDA Class II; FDA product code QBS, Radiological Computer Assisted Detection/Diagnosis Software For Fracture) made by Azmed Sas, cleared under FDA 510(k) K220164 on 2 Jun 2022 and listed in FDA GUDID since 10 Jun 2024 (UDI-DI 03770018071008), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03770018071008 | Date10 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220164 | Date2 Jun 2022 | StatusActive |
Official records
- AccessGUDID record 03770018071008
- FDA 510(k) database K220164
Across registries
- FDA 510(k) K220164 decided 2 Jun 2022 Active
- FDA GUDID UDI-DI 03770018071008 listed 10 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K220164
- Listed FDA GUDID 03770018071008
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rayvolve
- Generic name
- X-ray image interpretive software
- Model / reference
- 2
- Primary DI / UDI-DI
- 03770018071008
- 510(k) Number
- FDA product code
- QBS
- GMDN term
- X-ray image interpretive software
- Device class
- Class II
- Regulation number
- 892.2090
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).
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