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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namedigital mammographic x-ray system
Regulation Number892.1715
ApplicantGE HEALTHCARE
PMA NumberP990066
Supplement NumberS035
Date Received01/14/2010
Decision Date05/20/2010
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the amorphous silicon array design used in the detector of the senographe essential full field digital mammography system. The proposed modifications include the following: 1) reducing the number of layers in the detector amorphous silicon array; 2) change in the detector firmware to allow the detector configuration to be communicated to the system image detector controller (idc); 3) idc software to automatically determine is a detector with the proposed modification is installed on the system and properly select the proper configuration table; and 4) corresponding changes in the incoming acceptance criteria testing station for the modified detector.
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