Clearance Summary
VUZE System received FDA 510(k) clearance under submission number K210830, sponsored by Vuze Medical , 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 2022-01-03.
- Submission: K210830
- Applicant / Sponsor: Vuze Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2022-01-03
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.