Micro C Medical Imaging System, M01 is an AI-enabled medical device from OXOS Medical, Inc., listed by FDA (510(k), K212654) with a decision date of 2022-02-04. Review panel: Radiology.
| FDA submission number | K212654 |
|---|---|
| Pathway | 510(k) |
| Company | OXOS Medical, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2022-02-04 |
| Decision | Substantially Equivalent |
| Product code | IZL |
| Classification | System, X-Ray, Mobile |
| Device class | 2 |
| Regulation number | 892.1720 |
| Review time (calendar days) | 165 |
| Applicant country | US |
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.