510(k) K221949 ยท IZF System, X-Ray, Tomographic
Ortho Device, ADAPTIX 3D Orthopedic Imaging System
| Applicant | Pausch Medical GmbH, Erlangen, DE |
| Decision | Substantially Equivalent, Jan 26, 2023 |
| Received | Jul 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221949
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.