Clearance Summary
VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP received FDA 510(k) clearance under submission number K221911, sponsored by Vinno Technology (Suzhou) Co.,Ltd. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-12-21.
- Submission: K221911
- Applicant / Sponsor: Vinno Technology (Suzhou) Co.,Ltd
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2022-12-21
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.