Clearance Summary
Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) received FDA 510(k) clearance under submission number K180601, sponsored by Villa Sistemi Medicali S.P.A.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-11-02.
- Submission: K180601
- Applicant / Sponsor: Villa Sistemi Medicali S.P.A.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2018-11-02
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.