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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 NameICAD
Classification Nameanalyzer,medical image
Generic Namecomputer-aided detection system
ApplicantICAD, INC.
PMA NumberP010038
Supplement NumberS001
Date Received10/28/2002
Decision Date02/24/2003
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 use of the 3. 9. 3. 7 version of the software. The new software is intended to improve the overall sensitivity, improve the breast segmentation process, reduce the false marker rate and improve the overall consistency of the algorithm. The clinical performance claims are not changed.
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