510(k) K101347 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM AERA; MAGNETOM SKYRA
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 1, 2010 |
| Received | May 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101347
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc BIOGRAPH One (DE). Model Number: 11689172. 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 |
| Oct 17, 2016 | Siemens Medical Solutions USA, Inc Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems Terminated |
LNH | None listed |
| May 3, 2016 | Siemens Medical Solutions USA, Inc MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table. Terminated |
LNH | None listed |
| Sep 26, 2012 | Siemens Medical Solutions USA, Inc Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR
Nuclear Magnetic Resonance Imaging System and Tomographic Imager Terminated |
LNH | None listed |
| Feb 2, 2012 | Siemens Medical Solutions USA, Inc Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915.
Nuclear magnetic resonance imaging system. Terminated |
LNH | None listed |
| Aug 10, 2011 | Siemens Medical Solutions USA, Inc MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.