KONING BREAST CT (MODEL CBCT1000)

FDA Premarket Approval P130025

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.

Pre-market Approval Supplement Details

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).

• Device: KONING BREAST CT (MODEL CBCT1000)
• Generic Name: Cross-sectional Mammographic Xray System
• Applicant: KONING CORPORATION
• Date Received: 2013-11-25
• Decision Date: 2015-01-14
• Notice Date: 2015-02-09
• PMA: P130025
• Supplement: S
• Product Code: OLQ
• Docket Number: 15M-0200
• Advisory Committee: Radiology
• Expedited Review: No
• Combination Product: No
• Applicant Address: KONING CORPORATION 150 Lucius Gordon Drive suite 112 w Henrietta, NY 14586
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P130025		Original Filing
S003	2017-09-05	Real-time Process
S002	2015-12-28	Normal 180 Day Track
S001

NIH GUDID Devices

Device ID	PMA	Supp
19764496368300	P130025	004