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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 NumberS010
Date Received11/16/2001
Decision Date12/03/2001
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 A MODIFIED CONTROL CONSOLE INCLUDING MINOR HARDWARE AND SOFTWARE MODIFICATIONS TO THE APPROVED SYSTEM. THE SUPPLEMENT ALSO INCLUDES APPROPRIATE CHANGES IN THE LABELING TO REFLECT THESE CHANGES.
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