Device Classification Name |
solid state x-ray imager (flat panel/digital imager)
|
510(k) Number |
K042602 |
Device Name |
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING |
Applicant |
GE MEDICAL SYSTEMS, LLC |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
MARK M STAUFFER |
Correspondent |
GE MEDICAL SYSTEMS, LLC |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
MARK M STAUFFER |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 09/24/2004 |
Decision Date | 01/13/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|