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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.
 
DeviceKONING BREAST CT (MODEL CBCT 1000)
Generic NameCross-sectional mammographic xray system
ApplicantKoning Corporation
150 Lucius Gordon Dr.
Suite 112
W Henrietta, NY 14586
PMA NumberP130025
Supplement NumberS002
Date Received12/28/2015
Decision Date10/06/2016
Product Code OLQ 
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 changes to the patient table shape; detector upgrade; new quality control phantom and labeling; x-ray generator upgrade; image storage, display server and command processor upgrade; minor replacements of electrical components.
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