|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
ge 1.5t signa hde mr system
|
GE MEDICAL SYSTEMS, LLC
|
K052978 |
11/09/2005
|
ge 1.5t and 3.0t signa hdx mr system
|
GE MEDICAL SYSTEMS, LLC
|
K052293 |
09/21/2005
|
ge 0.7t signa openspeed with excite mr system
|
GE MEDICAL SYSTEMS, LLC
|
K032795 |
10/08/2003
|
ge 0.35t signa ovation with excite mr system
|
GE MEDICAL SYSTEMS
|
K053009 |
11/17/2005
|
functional brain mapping option for mri
|
GE MEDICAL SYSTEMS
|
K003947 |
03/13/2001
|
fiesta imaging option
|
GE MEDICAL SYSTEMS
|
K002997 |
04/11/2001
|
discovery mr750w 3.0t
|
GE MEDICAL SYSTEMS, LLC
|
K130115 |
05/23/2013
|
discovery mr750 3.0t; discovery mr750w 3.0t;discovery mr450 1.5t; discovery mr450w 1.5t; signa architect and signa artist
|
GE Medical Systems, LLC
|
K163331 |
03/17/2017
|
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
|
discovery mr750 3.0t, discovery mr450 1.5t, discovery mr750w 3.0t, optima mr450w 1.5t
|
GE MEDICAL SYSTEMS, LLC
|
K160618 |
06/09/2016
|
|