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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA 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
Supplement NumberS001
Date Received10/09/2012
Decision Date05/16/2013
Product Code
OTE[ Registered Establishments with OTE ]
Docket Number 13M-0595
Notice Date 05/23/2013
Advisory Committee Radiology
Clinical Trials NCT00971087
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
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 a 2d mammography system for screening mammograms. Specifically, the selenia dimensions system can be used to generate 2d digital mammograms and 3d mammograms. Each screening examination may consist of: a 2d ffdm image set; or a 2d and 3d image set, where the 2d image can be either a ffdm or a 2d image generated from the 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
Labeling Part 2