Device Classification Name |
Full Field Digital, System, X-Ray, Mammographic
|
510(k) Number |
K151645 |
Device Name |
MAMMOMAT Fusion |
Applicant |
Siemens Medical Solutions USA, Inc. |
51 Valley Stream Parkway |
Malvern,
PA
19355
|
|
Applicant Contact |
Darren Dorman |
Correspondent |
Siemens Medical Solutions USA, Inc. |
51 Valley Stream Parkway |
Malvern,
PA
19355
|
|
Correspondent Contact |
Darren Dorman |
Regulation Number | 892.1715
|
Classification Product Code |
|
Date Received | 06/18/2015 |
Decision Date | 09/14/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|