510(k) K212159 ยท OWB Interventional Fluoroscopic X-Ray System
Shield System
| Applicant | Radiaction , Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, Mar 30, 2022 |
| Received | Jul 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212159
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.