Clearance Summary
VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E received FDA 510(k) clearance under submission number K230160, sponsored by Vinno Technology (Suzhou) Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-06-23.
- Submission: K230160
- Applicant / Sponsor: Vinno Technology (Suzhou) Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2023-06-23
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.