510(k) K180601

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) by Villa Sistemi Medicali S.P.A. — Product Code OAS

K180601 is an FDA 510(k) premarket notification submitted by Villa Sistemi Medicali S.P.A. for the device "Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)". The FDA issued a decision of Substantially Equivalent on November 2, 2018. The device falls under product code OAS (X-Ray, Tomography, Computed, Dental), a Class II device regulated under 21 CFR 892.1750. Villa Sistemi Medicali S.P.A. has at least 10 other 510(k) clearances on record.