510(k) K231560 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 23, 2023 |
| Received | May 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231560
| 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 30, 2025 | Siemens Medical Solutions USA, Inc MAGNETOM Prisma. Model Number: 10849582. Open, Classified |
LNH | None listed |
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc MAGNETOM Skyra (DE). Model Number: 10432915.
510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560. Open, Classified |
LNH | None listed |
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc MAGNETOM Vida (DE). Model Number: 11060815.
510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560. Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.