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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 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 NumberS009
Date Received11/24/2006
Decision Date01/17/2007
Reclassified Date12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MOUNTING HOLOGIC SECURVIEW REFERENCE IMAGE VIEWER INTO THE SELENIA ACQUISITION WORKSTATION (AWS) CABINET FOR RETRIEVING AND DISPLAYING PATIENT?S PRIOR IMAGES BUT NOT FOR PRIMARY IMAGE DIAGNOSIS.
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