Clearance Summary
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) received FDA 510(k) clearance under submission number K201382, sponsored by De Gotzen S.R.L.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-11-18.
- Submission: K201382
- Applicant / Sponsor: De Gotzen S.R.L.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2020-11-18
Classification & Regulation
This clearance is catalogued under FDA product code OAS and 21 CFR 892.1750, within the Radiology review panel as a Class II device.