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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.
 
DeviceMAMMOGRAPHY CAD ENGINE
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantCARESTREAM HEALTH,INC.
150 Verona Street
ROCHESTER, NY 14608
PMA NumberP030007
Supplement NumberS001
Date Received07/05/2005
Decision Date09/16/2005
Withdrawal Date 11/13/2012
Product Code MYN 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MINOR UPDATED TO THE COMPUTER-ASSISTED DETECTION ALGORITHMS.
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