Atlas FDA

GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM

FDA 510(k) clearance K052293 · decided 2005-09-21

Clearance details

K-number
K052293
Device name
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
Applicant
Ge Medical Systems, LLC
Decision
Substantially Equivalent
Date received
2005-08-23
Decision date
2005-09-21
Days to decision
29 days
Clearance type
Special
Product code
LNH
Device class
2
Regulation number
892.1000
Medical specialty
Radiology
Advisory committee
Radiology
Location
Milwaukee, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 recall (Z-2463-2024)GE Medical Systems, LLC2024-08-02
1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, recall (Z-2471-2024)GE Medical Systems, LLC2024-08-02
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Re recall (Z-0860-2022)GE Healthcare, LLC2022-04-04
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system recall (Z-0141-2022)GE Healthcare, LLC2021-10-16
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System recall (Z-2065-2021)GE Healthcare, LLC2021-07-12
SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, recall (Z-0877-2020)GE Healthcare, LLC2020-01-28
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant recall (Z-3027-2017)GE Medical Systems, LLC2017-08-02
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body m recall (Z-0258-2016)GE Healthcare2015-11-10
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HD recall (Z-0259-2016)GE Healthcare2015-11-10
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCI recall (Z-1943-2013)GE Healthcare, LLC2013-08-09
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa H recall (Z-1207-2013)GE Healthcare, LLC2013-05-01
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa V recall (Z-0935-2013)GE Healthcare, LLC2013-03-11
5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Sign recall (Z-1428-2011)GE Healthcare, LLC2011-02-24
Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY recall (Z-0592-2010)GE Medical Systems, LLC2010-01-11
GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to recall (Z-1890-2008)GE Healthcare2008-09-17
GE 1.5T and 3.0T Signa HDx MR System Model Numbers: 5127452, 2377062-61, and 2395001-2. In recall (Z-2210-2008)GE Healthcare2008-09-16
GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 239500 recall (Z-2225-2008)GE Healthcare2008-09-11