Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K212621 |
Device Name |
MAMMOVISTA B.smart |
Applicant |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard |
Malvern,
PA
19355
|
|
Applicant Contact |
Martin Rajchel |
Correspondent |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard |
Malvern,
PA
19355
|
|
Correspondent Contact |
Martin Rajchel |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/18/2021 |
Decision Date | 11/12/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|