510(k) K243645 · IZI System, X-Ray, Angiographic
IC-Flow Imaging System 2.0
| Applicant | Diagnostic Green GmbH, Kirchheim B. München, DE |
| Decision | Substantially Equivalent, Sep 22, 2025 |
| Received | Nov 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243645
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.