BoneView is an AI-enabled medical device from Gleamer, listed by FDA (510(k), K212365) with a decision date of 2022-03-01. Review panel: Radiology.
| FDA submission number | K212365 |
|---|---|
| Pathway | 510(k) |
| Company | Gleamer |
| Review panel (specialty) | Radiology |
| FDA decision date | 2022-03-01 |
| 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) | 214 |
| Applicant country | FR |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.