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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 FOR MAMMOGRAPHY
Classification Nameanalyzer,medical image
Generic Namecomputer-aided detection system for mammography
ApplicantICAD, INC.
PMA NumberP010034
Supplement NumberS005
Date Received10/03/2003
Decision Date10/08/2003
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typereal-time process
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 cad system for mammography with the fisher imaging's senoscan full field digital mammography system.
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