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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
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantGE Healthcare
3000 N. GRANDVIEW BLVD
WAUKESHA, WI 53188
PMA NumberP990066
Supplement NumberS034
Date Received10/13/2009
Decision Date11/24/2009
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 A MODIFICATION TO THE SENOGRAPHE DS AND SENOGRAPHE ESSENTIAL FFDM SYSTEMS THAT WILL REMOVE BOTH MAGNIFICATION STANDS, AND CORRESPONDING MAGNIFICATION COMPRESSION PADDLES FOR BOTH SYSTEMS. THE COMPONENTS THAT ARE REMOVED FROM THE CONFIGURATION WILL STILL BE AVAILABLE TO THE CUSTOMER AS OPTIONAL EQUIPMENT.
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