|
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
|
1.5t optima mr430s
|
GE MEDICAL SYSTEMS, LLC
|
K103238 |
02/11/2011
|
1.5t signa hdxt 3.0t signa hdxt signa vibrant
|
GE MEDICAL SYSTEMS, LLC
|
K121676 |
09/20/2012
|
3d asl
|
GE MEDICAL SYSTEMS, LLC
|
K092925 |
01/06/2010
|
brainstat software option for ge signa mr scanner
|
GE MEDICAL SYSTEMS, LLC
|
K073167 |
01/04/2008
|
discovery mr450
|
GE MEDICAL SYSTEMS, LLC
|
K083147 |
11/04/2008
|
|