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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSELENIA DIMENSIONS 3D SYSTEM
Generic NameDigital breast tomosynthesis
ApplicantHOLOGIC, INC.
35 CROSBY DR.
BEDFORD, MA 01730
PMA NumberP080003
Supplement NumberS001
Date Received10/09/2012
Decision Date05/16/2013
Product Code OTE 
Docket Number 13M-0595
Notice Date 05/23/2013
Advisory Committee Radiology
Clinical TrialsNCT00971087
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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