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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.
 
DeviceSENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantHologic, Inc.
35 Crosby Dr.
Bedford, MA 01730
PMA NumberP010017
Supplement NumberS005
Date Received07/23/2004
Decision Date03/07/2005
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 ADDITION OF AUTOMATIC EXPOSURE SYSTEM, AND RELATED CHANGES IN OPERATOR'S MANUAL AND QC TEST AND QC MANUAL UNDER MQSA.
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