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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 NumberS008
Date Received06/25/2004
Decision Date09/01/2004
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 use of the second look digital computer-aided detection system with the hologic lorad selenia full-field digital mammographic system. The device, as modified, will be marketed under the trade name second look digital computer-aided detection system and is indicated for: the second look digital computer-aided detection system is intended to identify and mark regions of interest on screening and diagnostic mammograms from the hologic lorad selenia full-field digital mammographic system 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 on the original mammogram that may warrant a second review.
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