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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.
 
DeviceM-VU ALGOIRITHM ENGINE
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantIcad, Inc.
98 Spit Brook Rd., Suite 100
Nashua, NH 03062
PMA NumberP100005
Supplement NumberS001
Date Received05/21/2012
Decision Date10/01/2012
Reclassified Date02/21/2020
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 ALGORITHM UPDATES AND THE EXPANSION TO MULTIPLE MAMMOGRAPHY SYSTEMS.
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