KONING BREAST CT (MODEL CBCT 1000)
FDA premarket approval P130025/S002 · decided 2016-10-06
Approval details
- PMA number
- P130025
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 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
- Days to decision
- 283 days
- Decision code
- APPR
- Product code
- OLQ
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- W Henrietta, NY
- 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.
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