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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceKONING BREAST CT (MODEL CBCT1000)
Generic NameCross-sectional mammographic xray system
ApplicantKoning Corporation
150 Lucius Gordon Dr.
Suite 112
W Henrietta, NY 14586
PMA NumberP130025
Date Received11/25/2013
Decision Date01/14/2015
Product Code OLQ 
Docket Number 15M-0200
Notice Date 02/09/2015
Advisory Committee Radiology
Clinical TrialsNCT00972413
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE KONING BREAST CT (MODEL CBCT 1000). THIS DEVICE IS INDICATED AS FOLLOWS: KONING BREAST CT (CBCT1000) IS A CONE BEAM COMPUTED TOMOGRAPHY SYSTEM INTENDED TO PROVIDE THREE DIMENSIONAL IMAGES FOR DIAGNOSTIC IMAGING OF THE BREAST. KONING BREAST CT SHOULD BE READ ALONG WITH STANDARD 2-VIEW MAMMOGRAPHY (CC AND MLO VIEWS).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S003 S004 
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