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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 COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY
Classification Nameanalyzer,medical image
Generic Namecomputer-aided detection system for mammography
ApplicantCADX MEDICAL SYSTEMS INC.
PMA NumberP010034
Supplement NumberS001
Date Received03/04/2002
Decision Date05/07/2002
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an overall upgrade to the hardware and software in the device. These changes improved the sensitivity, decreased the marks per case and made an improvement in false negatives. In addition, soft-copy, increased storage, and dicom interfacing were added along with sundry other operating improvements.
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