510(k) K243077 ยท IZI System, X-Ray, Angiographic
Affirm 800
| Applicant | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery), Goleta CA, US |
| Decision | Substantially Equivalent, Jun 27, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243077
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.