|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
discovery mr750 3.0t, discovery mr450 1.5t, discovery mr750w 3.0t, optima mr450w 1.5t
|
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
|
K132376 |
11/15/2013
|
optima mr450w
|
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
|
K123522 |
03/13/2013
|
signa architect
|
GE Healthcare (GE Medical Systems, LLC)
|
K202966 |
11/13/2020
|
signa hero
|
GE Healthcare (GE Medical Systems, LLC)
|
K213668 |
01/20/2022
|
signa premier
|
GE Healthcare (GE Medical Systems, LLC)
|
K193282 |
04/10/2020
|
signa creator, signa explorer
|
GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC)
|
K143251 |
02/04/2015
|
1.5t infinity twinspeed mr system
|
GE MEDICAL SYSTEMS
|
K012200 |
08/03/2001
|
advantage windows tissue volume option
|
GE MEDICAL SYSTEMS
|
K963345 |
10/18/1996
|
advantage workstation pasting 1.1
|
GE MEDICAL SYSTEMS
|
K031396 |
05/13/2003
|
fiesta imaging option
|
GE MEDICAL SYSTEMS
|
K002997 |
04/11/2001
|