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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.
 
DeviceIMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantHologic, Inc.
35 Crosby Dr.
Bedford, MA 01730
PMA NumberP970058
Supplement NumberS024
Date Received09/18/2006
Decision Date02/09/2007
Reclassified Date02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT HOLOGIC, INC., BEDFORD, MASSACHUSETTS.
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