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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.
 
DeviceHOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantHOLOGIC, INC.
36 Apple Ridge Road
Danbury, CT 06810
PMA NumberP010025
Supplement NumberS019
Date Received06/01/2010
Decision Date11/16/2010
Reclassified Date 12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDITIONAL AUTOMATIC EXPOSURE CONTROL (AEC) TECHNIQUE TABLES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
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