Device Classification Name |
System, X-Ray, Mammographic
|
510(k) Number |
K964069 |
Device Name |
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVE. SOUTH |
ISELIN,
NJ
08830
|
|
Applicant Contact |
KATHLEEN RUTHERFORD |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVE. SOUTH |
ISELIN,
NJ
08830
|
|
Correspondent Contact |
KATHLEEN RUTHERFORD |
Regulation Number | 892.1710
|
Classification Product Code |
|
Date Received | 10/10/1996 |
Decision Date | 05/08/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|