FDA.reportPublic FDA data

PMA P130025S004

Device
Koning Breast CT, KBCT (Model CBCT1000)
Applicant
Koning Corporation
PMA number
P130025
Supplement
S004
Product code
OLQ
Decision date
2023-10-12
Classification
Radiology
Generic name
Cross-sectional mammographic xray system
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.

Current openFDA PMA Record#

Device
Koning Breast CT, KBCT (Model CBCT1000)
Applicant
Koning Corporation
PMA number
P130025
Supplement
S004
Product code
OLQ
Generic name
Cross-sectional mammographic xray system
Decision date
2023-10-12
Decision code
APPR
Date received
2023-07-26
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
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.