510(k) K203443 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Mar 31, 2021 |
| Received | Nov 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203443
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc MAGNETOM Lumina (DE). Model Number: 11344916. Open, Classified |
LNH | None listed |
| Sep 10, 2021 | Siemens Medical Solutions USA, Inc MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT
Material Numbers: 11060815 Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.