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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSECONDLOOK COMPUTER-AIDED DETECTION SYSTEM
Classification Nameanalyzer,medical image
Generic Namecomputer-aided detection system
ApplicantICAD, INC.
PMA NumberP010038
Supplement NumberS012
Date Received07/13/2006
Decision Date04/04/2008
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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