510(k) K213263 ยท LLZ System, Image Processing, Radiological
OnyxCeph
| Applicant | Image Instruments GmbH, 09123 Chemnitz, DE |
| Decision | Substantially Equivalent, Jan 4, 2023 |
| Received | Sep 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213263
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.