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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 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 NumberS014
Date Received06/03/2002
Decision Date06/13/2002
Reclassified Date12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF GRME AS AN ALTERNATIVE SUPPLIER OF THE GENERATOR COMPONENT OF THE GENERAL ELECTRIC MEDICAL SYSTEMS (GEMS) SENOGRAPHE 2000D FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) X-RAY SYSTEM.
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