510(k) K013636 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
| Applicant | GE Medical Systems, Milwaukee WI, US |
| Decision | Substantially Equivalent, Jan 24, 2002 |
| Received | Nov 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013636
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuclear magnetic resonance imaging 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 |
| Nov 10, 2015 | GE Healthcare GE Healthcare, SIGNA 3.0T.
Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil 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 |
| Aug 9, 2013 | GE Healthcare, LLC SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
GE SIGNA EXCITE 1.5T MR SYSTEM
GE SIGNA EXCITE 3.0T MR SYST Terminated |
LNH | None listed |
| Feb 24, 2011 | GE Healthcare, LLC 9) Signa Excite 1.5 T (Excite II)
(K013636 Signa Infinity MR System with EXCITE Technology)
Signa Infinity MR System with EXCITE
(K013636 Signa Infinity MR System with EXCITE Technology)
The Terminated |
LNH | None listed |
| Nov 24, 2010 | GE Healthcare, LLC Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201. Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.