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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 NameSENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namedigital mammographic x-ray system
Regulation Number892.1715
ApplicantGE MEDICAL SYSTEMS
PMA NumberP990066
Supplement NumberS004
Date Received06/08/2001
Decision Date12/06/2001
Product Code
MUE[ Registered Establishments with MUE ]
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 changes to the image chain software, specifically the automatic operating parameters (aop) and the auto-contrast and thickness compensation algorithms; the addition of some new features to the acquisition work station and the review work station that provide more options for image display and printing; and revised labeling to address the changes.
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