Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K955185 |
Device Name |
GE ADVANTAGE DICOM CR REPROCESSING STATION |
Applicant |
GE MEDICAL SYSTEMS |
3000 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
ALLEN SCHUH |
Correspondent |
GE MEDICAL SYSTEMS |
3000 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
ALLEN SCHUH |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/13/1995 |
Decision Date | 01/03/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|