510(k) K212336 ยท OWB Interventional Fluoroscopic X-Ray System
Soteria.AI
| Applicant | Omega Medical Imaging, LLC, Sanford FL, US |
| Decision | Substantially Equivalent, Nov 17, 2021 |
| Received | Jul 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212336
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.