Koning Breast CT, KBCT
FDA premarket approval P130025/S003 · decided 2017-10-24
Approval details
- PMA number
- P130025
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Koning Breast CT, KBCT
- Generic name
- Cross-sectional mammographic xray system
- Applicant
- Koning Corporation
- Date received
- 2017-09-05
- Decision date
- 2017-10-24
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- OLQ
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- W Henrietta, NY
- Statement
- Approval for changes to the input power requirements to 210-240 VAC, 30 AMP service and software changes associated with an added light switch, camera and touch screen interface.
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