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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 FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantHologic, Inc.
36 Apple Ridge Rd.
Danbury, CT 06810
PMA NumberP010025
Supplement NumberS003
Date Received04/15/2003
Decision Date10/10/2003
Reclassified Date12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING USER ENHANCEMENTS AND COMPONENTS; AN ADDITIONAL PERIPHERAL CONTRAST ENHANCEMENT (PCE) BASED IMAGE PROCESSING MECHANISM; THE ADDITION OF A HIGH RESOLUTION FUJI FM-DP L IMAGE PRINTER; AND UPDATED LABELING CHANGES FOR THE SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (FFDM).
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