Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)

K180601 is the FDA 510(k) clearance record for Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology), a class II device, cleared for Villa Sistemi Medicali S.P.A. on 2018-11-02 under FDA product code OAS (X-Ray, Tomography, Computed, Dental). FDA's definition for product code OAS reads: "Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth". FDA records list 13 510(k) clearances for Villa Sistemi Medicali S.P.A., from 1999-01-14 to 2018-11-02. As of 2026-09-10, FDA records show no recalls naming K180601.