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Device | MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION |
Generic Name | Digital breast tomosynthesis |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MALVERN, PA 19355-1406 |
PMA Number | P140011 |
Supplement Number | S001 |
Date Received | 11/23/2015 |
Decision Date | 05/12/2016 |
Product Code |
OTE |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for change to the indications for use statement. The device, as modified, will be marketed under the trade name MAMMOMAT Inspiration with Tomosynthesis Option and is indicated for acquisition of 2D as well as 3D digital mammography images to be used in screening and diagnosis of breast cancer. A screening examination may consist of a 3D DBT image set and/or a 2D FFDM image set. |