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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, KBCT (Model CBCT1000)
Generic NameCross-sectional mammographic xray system
ApplicantKoning Corporation
150 Lucius Gordon Dr.
Suite 112
W Henrietta, NY 14586
PMA NumberP130025
Supplement NumberS004
Date Received07/26/2023
Decision Date10/12/2023
Product Code OLQ 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for (1) modifications to hardware components, specifically the Xray Generator, Tube, and Detector, and (2) software enhancements such as improved GUI features for both the console and viewer, transition from touchscreen to hard buttons for motion control, and additional features tailored for health care provider convenience.
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