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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 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 NumberS019
Date Received04/18/2005
Decision Date05/25/2005
Reclassified Date 12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES IN TWO SOFTWARE MODIFICATIONS THAT HAVE BEEN MADE TO THE ACQUISITION WORKSTATION (AWS) AND FOR AN ADDITIONAL SUPPLIER FOR THE CONDITIONER (CHILLER FOR THE IMAGE RECEPTOR). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM AND IS INDICATED AS FOLLOWS: THE SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. THE SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM IS INTENDED TO BE USED IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHIC SYSTEM.
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