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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
Classification Namefull field digital,system,x-ray,mammographic
Generic Namedigital mammographic x-ray system
Regulation Number892.1715
ApplicantGE MEDICAL SYSTEMS
PMA NumberP990066
Supplement NumberS015
Date Received10/03/2002
Decision Date11/21/2002
Product Code
MUE[ Registered Establishments with MUE ]
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 modifications to the approved system to permit use of an optional contrast enhancement algorithm (dynamic range management) introduction of new display protocols and minor changes in the display scenarios, and addition of keyboard shortcuts for window width/window level settings. The supplement also includes changes in the labeling to reflect the modifications listed above.
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