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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.
 
DeviceFISCHER IMAGING CORPORATION SENOSCAN 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 NumberS007
Date Received01/20/2006
Decision Date02/13/2006
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR SOFTWARE CHANGES TO CORRECT SEVERAL "BUGS" THAT IMPROVE SERVICE WORKFLOW EFFICIENCY, IMPROVE USER WORKFLOW EFFICIENCY, AND IMPROVE IMAGE ARCHIVING.
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