510(k) K033504 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Nov 25, 2003 |
| Received | Nov 5, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033504
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2018 | GE Healthcare, LLC Various GE Magnetic Resonance System on-site software version
Product Usage:
Magnetic resonance imaging equipment for general diagnostic use Terminated |
LNH | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.