510(k) K250443 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
| Applicant | Siemens Healthcare GmbH, Erlangen, DE |
| Decision | Substantially Equivalent, Jun 16, 2025 |
| Received | Feb 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250443
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc MAGNETOM Skyra fit. Model Number: 10849580. Open, Classified |
LNH | None listed |
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.