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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameDigital breast tomosynthesis
ApplicantHOLOGIC, INC.
35 CROSBY DR.
BEDFORD, MA 01730
PMA NumberP080003
Date Received01/22/2008
Decision Date02/11/2011
Product Code OTE 
Docket Number 11M-0131
Notice Date 03/09/2011
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S004 S001 S003 S005 S006 S007 S008 
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