- Device
- Koning Breast CT, KBCT
- Applicant
- Koning Corporation
- PMA number
- P130025
- Supplement
- S003
- Product code
- OLQ
- Generic name
- Cross-sectional mammographic xray system
- Decision date
- 2017-10-24
- Decision code
- APPR
- Date received
- 2017-09-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.