Rayvolve is an AI-enabled medical device from AZmed, listed by FDA (510(k), K260378) with a decision date of 2026-05-12. Review panel: Radiology.
| FDA submission number | K260378 |
|---|---|
| Pathway | 510(k) |
| Company | AZmed |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-05-12 |
| Decision | Substantially Equivalent |
| Product code | QBS |
| Classification | Radiological Computer Assisted Detection/Diagnosis Software For Fracture |
| Device class | 2 |
| Regulation number | 892.2090 |
| Review time (calendar days) | 96 |
| Applicant country | FR |
Official FDA database record · FDA AI-enabled device list
More devices from AZmed · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.