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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.
 
DeviceSECONDLOOK DIGITAL V7.2 CAD
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
ICAD, INC.
98 spit brook road
suite 100
nashua, NH 03062
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/material
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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