Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K033400 |
Device Name |
SENO ADVANTAGE |
Applicant |
GE MEDICAL SYSTEMS W-400 |
3000 NORTH GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
LARRY A KROGER, PH.D. |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 10/24/2003 |
Decision Date | 12/04/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|