510(k) K052293 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
| Applicant | Ge Medical Systems, LLC, Milwaukee WI, US |
| Decision | Substantially Equivalent, Sep 21, 2005 |
| Received | Aug 23, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052293
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2024 | GE Medical Systems, LLC 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Apr 4, 2022 | GE Healthcare, LLC 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIG Open, Classified |
LNH | None listed |
| Oct 16, 2021 | GE Healthcare, LLC 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system Terminated |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Jan 28, 2020 | GE Healthcare, LLC SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, hig 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 2, 2017 | GE Medical Systems, LLC 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant
Product Usage:
The GE Signa HDx MR system is a whole body magnetic resonance scanner designed to support Terminated |
LNH | None listed |
| Nov 10, 2015 | GE Healthcare GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device. Terminated |
LNH | None listed |
| Nov 10, 2015 | GE Healthcare GE Healthcare, SIGNA HDxt 3.0T.
Product Usage:
The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device. 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 |
| May 1, 2013 | GE Healthcare, LLC GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant.
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 5) Signa HDx (K052293 Signa HDx and HDxt MR Systems)
Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems)
Signa HDxt (K052293 Signa HDx and HDxt MR Systems )
The GE Signa HD 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 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of Terminated |
LNH | None listed |
| Sep 16, 2008 | GE Healthcare GE 1.5T and 3.0T Signa HDx MR System
Model Numbers: 5127452, 2377062-61, and 2395001-2.
Indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectr Terminated |
LNH | None listed |
| Sep 11, 2008 | GE Healthcare GE 1.5T and 3.0T Signa HDX MR System
Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is 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.