510(k) K113511 ยท LNH System, Nuclear Magnetic Resonance Imaging
ECHOSTAR SPICA 1.5T MR SYSTEM
| Applicant | Alltech Medical Systems America, Inc., Solon OH, US |
| Decision | Substantially Equivalent, May 2, 2012 |
| Received | Nov 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113511
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2015 | Alltech Medical Systems America Inc Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body. Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.