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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.
 
DeviceSECONDLOOK COMPUTER-AIDED DETECTION SYSTEM
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantICAD, INC.
98 SPIT BROOK ROAD
SUITE 100
NASHUA, NH 03062
PMA NumberP010038
Supplement NumberS012
Date Received07/12/2006
Decision Date04/04/2008
Reclassified Date 02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF THE SECONDLOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY WITH FUJI MEDICAL SYSTEMS COMPUTED RADIOGRAPHY MAMMOGRAMS (CRM). THE DEVICE IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM FUJIFILM MEDICAL SYSTEMS COMPUTED RADIOGRAPHY SYSTEM (FUJI CRM) TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER AN INITIAL READING HAS BEEN COMPLETED.
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