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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namedigital breast tomosynthesis
Generic Namedigital breast tomosynthesis
51 valley stream pkwy.
malvern, PA 19355-1406
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
Recalls CDRH Recalls
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002