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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.
 
DeviceICAD
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantIcad, Inc.
98 Spit Brook Rd., Suite 100
Nashua, NH 03062
PMA NumberP010038
Supplement NumberS002
Date Received10/28/2002
Decision Date11/20/2002
Reclassified Date02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A DEVICE NAME CHANGE FROM "MAMMOREADER" TO "ICAD."
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