Clearance Summary
Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) received FDA 510(k) clearance under submission number K162190, sponsored by Villa Sistemi Medicali S.P.A.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-07-06.
- Submission: K162190
- Applicant / Sponsor: Villa Sistemi Medicali S.P.A.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2017-07-06
Classification & Regulation
This clearance is catalogued under FDA product code MUH and 21 CFR 872.1800, within the Dental review panel as a Class II device.