510(k) K052978 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE 1.5T SIGNA HDE MR SYSTEM
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 9, 2005 |
| Received | Oct 24, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052978
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| May 1, 2013 | GE Healthcare, LLC GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM.
Indicated for use as a diagnostic imaging device. Terminated |
LNH | None listed |
| Mar 11, 2013 | GE Healthcare, LLC Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System.
The GE Signa HDx MR system is a whole body magnetic resonance scann Terminated |
LNH | None listed |
| Feb 24, 2011 | GE Healthcare, LLC 4) Signa HDe (K052978 GE 1.5T Signa HDe MR System)
The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short Terminated |
LNH | None listed |
| Jan 11, 2010 | GE Medical Systems, LLC Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.