510(k) K962061 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
| Applicant | GE Medical Systems, Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 27, 1996 |
| Received | May 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, a Open, Classified |
LNH | None listed |
| Feb 24, 2011 | GE Healthcare, LLC 1) Signa Lx
( K962061 Signa Horizon Cx)
The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of th Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.