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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 (SL) CAD
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
ICAD, INC.
98 spit brook road
suite 100
nashua, NH 03062
PMA NumberP010038
Supplement NumberS015
Date Received05/19/2008
Decision Date10/09/2008
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at icad, inc. , nashua, new hampshire.
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