Atlas FDA

SIGNA 3.0T MR750 SYSTEM

FDA 510(k) clearance K081028 · decided 2008-04-25

Clearance details

K-number
K081028
Device name
SIGNA 3.0T MR750 SYSTEM
Applicant
Ge Medical Systems, LLC
Decision
Substantially Equivalent
Date received
2008-04-11
Decision date
2008-04-25
Days to decision
14 days
Clearance type
Traditional
Product code
LNH
Device class
2
Regulation number
892.1000
Medical specialty
Radiology
Advisory committee
Radiology
Location
Waukesha, WI, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whol recall (Z-3025-2017)GE Medical Systems, LLC2017-08-02
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. recall (Z-0201-2019)GE Medical Systems, LLC2015-12-28
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with recall (Z-1533-2014)GE Healthcare, LLC2014-05-01
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discov recall (Z-1480-2014)GE Healthcare, LLC2014-04-21
GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanne recall (Z-2291-2013)GE Healthcare, LLC2013-09-27
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model recall (Z-2266-2013)GE Healthcare, LLC2013-09-23
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
GE Healthcare, 3.0T Signa MR750 (Marketing Name: GE Discovery MR750) Product Usage: The GE recall (Z-3122-2011)GE Healthcare, LLC2011-09-01
GE Healthcare Discovery MR750 3.0T The GE Signa MR750 System is a whole body magnetic reso recall (Z-1375-2011)GE Healthcare, LLC2011-02-18
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