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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 AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
Applicant
GE Healthcare
3000 n. grandview blvd
waukesha, WI 53188
PMA NumberP990066
Supplement NumberS028
Date Received02/21/2007
Decision Date04/13/2007
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR 1) A NEW COMPUTER; 2) MODIFICATION OF THE SOFTWARE; 3) ADDITION OF A THIRD PARTY SOFTWARE PROGRAM; 4) CHANGES IN THE PROPRIETARY SOFTWARE; AND 5) REPLACEMENT OF THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WITH A SMALLER TYPE.
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