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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 NameSECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
Classification Nameanalyzer,medical image
Generic Namecomputer-aided detection system
ApplicantICAD, INC.
PMA NumberP010038
Supplement NumberS009
Date Received01/18/2005
Decision Date03/07/2005
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track no user fee
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for private label distribution (hologic, inc. To distribute second look). The device, as modified, will be marketed under the trade name securlook and is indicated for: the securlook computer-aided detection system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas of the original mammogram that may warrant a second review.
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