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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 DIGITAL V7.2 CAD
Classification Nameanalyzer,medical image
Generic Namecomputer-aided detection system
ApplicantICAD, INC.
PMA NumberP010038
Supplement NumberS016
Date Received08/10/2012
Decision Date11/09/2012
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the secondlook digital v7. 2 cad for use with the philips microdose full-field digital mammography (ffdm) system.
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