510(k) K043262 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE SIGNA EXCITE MR SURGICAL OPTION
| Applicant | GE Healthcare, Milwaukee WI, US |
| Decision | Substantially Equivalent, Jan 12, 2005 |
| Received | Nov 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043262
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2015 | GE Medical Systems, LLC MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS.
UPDATE 11-4-2015: Model M0001SS Terminated |
LNH | None listed |
| Feb 21, 2012 | GE Healthcare, LLC GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite).
The MR Surgical Option when integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used t Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.