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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 COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantIcad, Inc.
98 Spit Brook Rd., Suite 100
Nashua, NH 03062
PMA NumberP010034
Supplement NumberS001
Date Received03/04/2002
Decision Date05/07/2002
Withdrawal Date04/08/2011
Product Code MYN 
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 AN OVERALL UPGRADE TO THE HARDWARE AND SOFTWARE IN THE DEVICE. THESE CHANGES IMPROVED THE SENSITIVITY, DECREASED THE MARKS PER CASE AND MADE AN IMPROVEMENT IN FALSE NEGATIVES. IN ADDITION, SOFT-COPY, INCREASED STORAGE, AND DICOM INTERFACING WERE ADDED ALONG WITH SUNDRY OTHER OPERATING IMPROVEMENTS.
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