510(k) K053009 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
| Applicant | GE Medical Systems, Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 17, 2005 |
| Received | Oct 26, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053009
| 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 |
| May 1, 2013 | GE Healthcare, LLC GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System.
Indicated for use as a diagnostic imaging device. Terminated |
LNH | None listed |
| Aug 25, 2009 | GE Medical Systems, LLC GE Healthcare Signa Ovation 0.35T, Model Numbers:
Ovation 1-3 (2276937), Ovation 4 (2377062-2, 2377062-5, 2377062-8, or 5118172), and Ovation 5 (5148725).
The 0.35T Signa Ovation with Excite Magnetic Terminated |
LNH | None listed |
| Jun 30, 2009 | GE Medical Systems, LLC GE Signa Ovation 0.35 T MR System.
The Signa Ovation System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.