Soteria.AI is an AI-enabled medical device from Omega Medical Imaging, LLC, listed by FDA (510(k), K212336) with a decision date of 2021-11-17. Review panel: Radiology.
| FDA submission number | K212336 |
|---|---|
| Pathway | 510(k) |
| Company | Omega Medical Imaging, LLC |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-11-17 |
| Decision | Substantially Equivalent |
| Product code | OWB |
| Classification | Interventional Fluoroscopic X-Ray System |
| Device class | 2 |
| Regulation number | 892.1650 |
| Review time (calendar days) | 113 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.