Koning Breast CT, KBCT (Model CBCT1000)
FDA premarket approval P130025/S004 · decided 2023-10-12
Approval details
- PMA number
- P130025
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Koning Breast CT, KBCT (Model CBCT1000)
- Generic name
- Cross-sectional mammographic xray system
- Applicant
- Koning Corporation
- Date received
- 2023-07-26
- Decision date
- 2023-10-12
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- OLQ
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- W Henrietta, NY
- 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.
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