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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.
 
DeviceSENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantGE Healthcare
3000 N. GRANDVIEW BLVD
WAUKESHA, WI 53188
PMA NumberP990066
Supplement NumberS020
Date Received05/03/2005
Decision Date07/01/2005
Reclassified Date 12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SOFTWARE CHANGES TO THE SENOGRAPHE DS AND (2000D) FFDM ACQUITION WORKSTATION (AWS) AND REVIEW WORKSTATION TO ALLOW USERS TO SELECT THE PREMIUM VIEW (PV) ALGORITHM AS PRIMARY IMAGE PROCESSING.
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