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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 CAD SYSTEM FOR MAMMOGRAPHY
Classification Nameanalyzer,medical image
Generic Namecomputer-aided detection system for mammography
ApplicantCADX MEDICAL SYSTEMS INC.
PMA NumberP010034
Supplement NumberS003
Date Received02/27/2003
Decision Date08/11/2003
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the second look digital cad system for gems senographie 2000d full field digital mammography. The changes include software upgrade to accommodate digital image processing and an addition of rack mountable hardware. The device, as modified, will be marketed under the trade name second look digital cad system for mammography and is indicated for identification and marking regions of interest on screening and diagnostic mammograms from general electric medical systems senographie 2000d full field digital mammography system to bring them to the attention of the radiologist after the initial reading has been completed.
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