510(k) K002611 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
| Applicant | GE Medical Systems, Milwaukee WI, US |
| Decision | Substantially Equivalent, Oct 31, 2000 |
| Received | Aug 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002611
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2010 | GE Healthcare, LLC Signa Ovation, 0.35T MR Systems (MFO 1-4).
Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and Terminated |
LNH | None listed |
| Nov 7, 2007 | GE Healthcare Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2 Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.