Device Classification Name |
System, X-Ray, Mammographic
|
510(k) Number |
K003945 |
Device Name |
OPDIMA |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Applicant Contact |
PRAVEEN NADKARNI |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Correspondent Contact |
PRAVEEN NADKARNI |
Regulation Number | 892.1710
|
Classification Product Code |
|
Date Received | 12/21/2000 |
Decision Date | 02/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|