Device Classification Name |
system, x-ray, stationary
|
510(k) Number |
K050704 |
Device Name |
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING |
Applicant |
GENERAL ELECTRIC CO. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
JOHN L SCHMIDT |
Correspondent |
GENERAL ELECTRIC CO. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
JOHN L SCHMIDT |
Regulation Number | 892.1680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/18/2005 |
Decision Date | 04/08/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|