Device Classification Name |
system, x-ray, stationary
|
510(k) Number |
K992066 |
Device Name |
REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM |
Applicant |
GE MEDICAL SYSTEMS |
3000 N GRANDVIEW BLVD. |
W-709 |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
LARRY A KROGER |
Correspondent |
GE MEDICAL SYSTEMS |
3000 N GRANDVIEW BLVD. |
W-709 |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
LARRY A KROGER |
Regulation Number | 892.1680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/18/1999 |
Decision Date | 08/30/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|