Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K081985 |
Device Name |
AW SERVER |
Applicant |
GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW BLVD. |
W706 |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
STEPHEN SLAVENS |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
JAY Y KOGOMA |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/14/2008 |
Decision Date | 09/25/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|