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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameMAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
Classification Namedigital breast tomosynthesis
Generic Namefull field digital mommamat (ffdm) system with tomosynthesis option
ApplicantSIEMENS MEDICAL SOLUTIONS USA, INC.
PMA NumberP140011
Date Received06/26/2014
Decision Date04/21/2015
Product Code
OTE[ Registered Establishments with OTE ]
Docket Number 15M-1460
Notice Date 05/18/2015
Advisory Committee Radiology
Clinical Trials NCT01373671
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the mammomat inspiration with tomosynthesis option. This device is indicated for the acquisition of 2d as well as 3d digital mammography images to be used in screening and diagnosis of breast cancer. Each screening examination may consist of cc and mlo views in: a 2d image set, or a 2d and 3d image set. Note: the screening examination may consist of 2d ffdm images set with or without the 3d image set.
Approval Order Approval Order
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