Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K960613 |
Device Name |
GE ADVANTAGE WINDOWS REVIEW WORKSTATION |
Applicant |
GE MEDICAL SYSTEMS |
PO BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
LARRY A KROGER, PH.D. |
Correspondent |
GE MEDICAL SYSTEMS |
PO BOX 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
LARRY A KROGER, PH.D. |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 02/13/1996 |
Decision Date | 04/30/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|