KONING BREAST CT (MODEL CBCT 1000)

FDA Premarket Approval P130025 S002

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.

Pre-market Approval Supplement Details

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.

• Device: KONING BREAST CT (MODEL CBCT 1000)
• Generic Name: Cross-sectional Mammographic Xray System
• Applicant: KONING CORPORATION
• Date Received: 2015-12-28
• Decision Date: 2016-10-06
• PMA: P130025
• Supplement: S002
• Product Code: OLQ
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: KONING CORPORATION 150 Lucius Gordon Drive suite 112 w Henrietta, NY 14586

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