510(k) K212145 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
DR 800 with DSA, DR 800
| Applicant | Agfa N.V., Mortsel, BE |
| Decision | Substantially Equivalent, Aug 31, 2021 |
| Received | Jul 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212145
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.