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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.
 
DeviceSECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantIcad, Inc.
98 Spit Brook Rd., Suite 100
Nashua, NH 03062
PMA NumberP010034
Supplement NumberS005
Date Received10/03/2003
Decision Date10/08/2003
Withdrawal Date04/08/2011
Product Code MYN 
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 THE USE OF THE SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY WITH THE FISHER IMAGING'S SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
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