510(k) K942604 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
| Applicant | GE Medical Systems, Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 24, 1995 |
| Received | Jun 1, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2011 | GE Healthcare, LLC 2) Signa Advantage SP
(K942604 Signa Advantage SP MR System)
A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.