510(k) K012200 ยท LNH System, Nuclear Magnetic Resonance Imaging
1.5T INFINITY TWINSPEED MR SYSTEM
| Applicant | GE Medical Systems, Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 3, 2001 |
| Received | Jul 13, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012200
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2022 | GE Healthcare, LLC Signa 1.5T TwinSpeed Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system. Open, Classified |
LNH | None listed |
| 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 |
| Jun 7, 2018 | GE Medical Systems, LLC GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names:
1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS,
1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1. Terminated |
LNH | None listed |
| Jun 7, 2018 | GE Medical Systems, LLC GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names:
SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II Terminated |
LNH | None listed |
| Jun 7, 2018 | GE Medical Systems, LLC GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names:
*ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *T Terminated |
LNH | None listed |
| Aug 5, 2015 | GE Healthcare GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Si Terminated |
LNH | None listed |
| Mar 20, 2015 | GE Healthcare GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Disc Terminated |
LNH | None listed |
| Feb 18, 2015 | GE Healthcare This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.