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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
Applicant
GE Healthcare
3000 n. grandview blvd
waukesha, WI 53188
PMA NumberP990066
Supplement NumberS030
Date Received03/26/2008
Decision Date05/27/2008
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE MODIFICATION OF AUTOMATIC OPTIMIZATION OF PARAMETERS (AOP) SOFTWARE TO INCREASE CONTRAST TO NOISE RATIO FOR THICKER DENSER BREASTS.
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