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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
35 crosby dr.
bedford, MA 01730
PMA NumberP080003
Date Received01/22/2008
Decision Date02/11/2011
Product Code
OTE[ Registered Establishments with OTE ]
Docket Number 11M-0131
Notice Date 03/09/2011
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the selenia dimensions 3d system. This device is indicated to generate digital mammographic images that can be used for screening and diagnosis of breast cancer. The selenia dimensions (2d or 3d) system is intended for use in the same clinical applications as 2d mammography systems for screening mammograms. Specifically, the selenia dimensions system can be used to acquire 2d digital mammograms and 3d mammograms. The screening examination will consist of a 2d image set or a 2d and 3d image set. The selenia dimensions system may also be used for additional diagnostic workup of the breast.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S003