ClearanceBrief
510(k) K052293 ยท LNH System, Nuclear Magnetic Resonance Imaging

GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM

ApplicantGe Medical Systems, LLC, Milwaukee WI, US
DecisionSubstantially Equivalent, Sep 21, 2005
ReceivedAug 23, 2005
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K052293

DateFirm and productCodeLinked 510(k)
Aug 2, 2024GE 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
LNHNone listed
Aug 2, 2024GE 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
LNHNone listed
Apr 4, 2022GE 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
LNHNone listed
Dec 23, 2021GE 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
LNHNone listed
Oct 16, 2021GE Healthcare, LLC
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Terminated
LNHNone listed
Jul 12, 2021GE Healthcare, LLC
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
Open, Classified
LNHNone listed
Jan 28, 2020GE 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
LNHNone listed
Jun 7, 2018GE 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
LNHNone listed
Jun 7, 2018GE 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
LNHNone listed
Jun 7, 2018GE 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
LNHNone listed
Aug 2, 2017GE 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
LNHNone listed
Nov 10, 2015GE 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
LNHNone listed
Nov 10, 2015GE 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
LNHNone listed
Aug 9, 2013GE 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
LNHNone listed
May 1, 2013GE 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
LNHNone listed
Mar 11, 2013GE 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
LNHNone listed
Feb 24, 2011GE 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
LNHNone listed
Jan 11, 2010GE 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
LNHNone listed
Sep 17, 2008GE 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
LNHNone listed
Sep 16, 2008GE 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
LNHNone listed
Sep 11, 2008GE 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
LNHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.