510(k) K193262 ยท IZF System, X-Ray, Tomographic
DR 600 with Tomosynthesis
| Applicant | Agfa N.V., Mortsel, BE |
| Decision | Substantially Equivalent, Mar 9, 2020 |
| Received | Nov 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193262
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.