Device Classification Name |
Full Field Digital, System, X-Ray, Mammographic
|
510(k) Number |
K122286 |
Device Name |
MAMMOMAL INSPIRATION |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PKWY. |
MALVERN,
PA
19355 -1406
|
|
Applicant Contact |
PATRICIA D JONES |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PKWY. |
MALVERN,
PA
19355 -1406
|
|
Correspondent Contact |
PATRICIA D JONES |
Regulation Number | 892.1715
|
Classification Product Code |
|
Date Received | 07/30/2012 |
Decision Date | 02/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|