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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.
 
DeviceGE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM
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 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/material
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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