510(k) K121434 ยท LNH System, Nuclear Magnetic Resonance Imaging
SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
| Applicant | Siemens Medi Cal Solutions, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Nov 5, 2012 |
| Received | May 14, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121434
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc MAGNETOM Verio Dot. Model Number: 10684333. Open, Classified |
LNH | None listed |
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc MAGNETOM Verio Dot Upgrade. Model Number: 10684334. Open, Classified |
LNH | None listed |
| Mar 20, 2015 | Siemens Medical Solutions USA, Inc MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-s Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.