Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K122164 |
Device Name |
MR VESSELLQ XPRESS |
Applicant |
GE MEDICAL SYSTEMS SCS |
3000 NORTH GRANDVIEW |
W1140 |
waukesha,
WI
53188
|
|
Applicant Contact |
helen peng |
Correspondent |
GE MEDICAL SYSTEMS SCS |
3000 NORTH GRANDVIEW |
W1140 |
waukesha,
WI
53188
|
|
Correspondent Contact |
helen peng |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/20/2012 |
Decision Date | 09/07/2012 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|