510(k) K032795 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 8, 2003 |
| Received | Sep 8, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| Feb 24, 2011 | GE Healthcare, LLC 7) Signa OpenSpeed
(K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System)
The 0.7T Signa Openspeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support Terminated |
LNH | None listed |
| Nov 19, 2010 | GE Healthcare, LLC Signa OpenSpeed, 0.7T MR Systems (HFO3-5). Terminated |
LNH | None listed |
| Aug 25, 2009 | GE Medical Systems, LLC Signa Openspeed 0.7T MR Systems, Model Numbers:
Openspeed 3 (2138300-30), Openspeed 4 (2377062-5), Openspeed 5 (2377062-5, 2377062-30) Terminated |
LNH | None listed |
| Jun 30, 2009 | GE Medical Systems, LLC GE Signa OpenSpeed 0.7T MR System.
The 0.7T Signa OpenSpeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter sca Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.