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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
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 NumberS015
Date Received10/03/2002
Decision Date11/21/2002
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODIFICATIONS TO THE APPROVED SYSTEM TO PERMIT USE OF AN OPTIONAL CONTRAST ENHANCEMENT ALGORITHM (DYNAMIC RANGE MANAGEMENT) INTRODUCTION OF NEW DISPLAY PROTOCOLS AND MINOR CHANGES IN THE DISPLAY SCENARIOS, AND ADDITION OF KEYBOARD SHORTCUTS FOR WINDOW WIDTH/WINDOW LEVEL SETTINGS. THE SUPPLEMENT ALSO INCLUDES CHANGES IN THE LABELING TO REFLECT THE MODIFICATIONS LISTED ABOVE.
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