510(k) K253495 ยท LLZ System, Image Processing, Radiological
syngo.MR Applications (VB80)
| Applicant | Siemens Healthineers AG, Forchheim, DE |
| Decision | Substantially Equivalent, Nov 20, 2025 |
| Received | Oct 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253495
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.