510(k) K111242 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM AERA AND MAGNETOM SKYRA
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Nov 23, 2011 |
| Received | May 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111242
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2019 | Siemens Medical Solutions USA, Inc MAGNETOM Aera magnetic resonance diagnostic devices
Model # 10432914 Terminated |
LNH | None listed |
| Jul 9, 2019 | Siemens Medical Solutions USA, Inc MAGNETOM Skyra magnetic resonance diagnostic devices
Model # 10432915 Terminated |
LNH | None listed |
| May 27, 2014 | Siemens Medical Solutions USA, Inc MAGNETOM Aera magnetic resonance system.
Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscop Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.