PMA P130025S002

Device: KONING BREAST CT (MODEL CBCT 1000)
Applicant: Koning Corporation
PMA number: P130025
Supplement: S002
Product code: OLQ
Decision date: 2016-10-06
Generic name: Cross-sectional mammographic xray system
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.

Current openFDA PMA Record#

Device: KONING BREAST CT (MODEL CBCT 1000)
Applicant: Koning Corporation
PMA number: P130025
Supplement: S002
Product code: OLQ
Generic name: Cross-sectional mammographic xray system
Decision date: 2016-10-06
Decision code: APPR
Date received: 2015-12-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.