510(k) K041476 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
| Applicant | Ge Medical Systems, LLC, Milwaukee WI, US |
| Decision | Substantially Equivalent, Jun 17, 2004 |
| Received | Jun 3, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041476
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2022 | GE Healthcare, LLC 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance imaging system. Open, Classified |
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 |
| Mar 30, 2018 | GE Medical Systems, LLC MR Surgical Suite Option
Product The MR Surgical Option when integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole bo Terminated |
LNH | None listed |
| Nov 10, 2015 | GE Healthcare GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventi 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 6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T)
Signa Excite, 12x (K041476 Signa Excite 1.5T and 3.0T)
The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support h 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 |
| Sep 17, 2008 | GE Healthcare GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or Terminated |
LNH | None listed |
| Sep 16, 2008 | GE Healthcare GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System.
Model Numbers 5107849, 5107849-2, M3000PT, and M3000PW .
Indicated for use as a diagnostic imaging device to produce axial Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.