Device Classification Name |
system, x-ray, mammographic
|
510(k) Number |
K953250 |
Device Name |
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE |
Applicant |
GE MEDICAL SYSTEMS |
P.O. 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
LARRY A KROGER |
Correspondent |
GE MEDICAL SYSTEMS |
P.O. 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
LARRY A KROGER |
Regulation Number | 892.1710
|
Classification Product Code |
|
Date Received | 07/12/1995 |
Decision Date | 01/26/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|