Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K050943 |
Device Name |
GE VIEWPOINT |
Applicant |
GENERAL ELECTRIC CO. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
ALLEN SCHUH |
Correspondent |
GENERAL ELECTRIC CO. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
ALLEN SCHUH |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/14/2005 |
Decision Date | 05/23/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|