Cleared Abbreviated

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

K180601 · Villa Sistemi Medicali S.P.A. · Radiology
Nov 2018
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K180601 is an FDA 510(k) clearance for the Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology), a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Villa Sistemi Medicali S.P.A. (Buccinasco, IT). The FDA issued a Cleared decision on November 2, 2018, 240 days after receiving the submission on March 7, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K180601 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2018
Decision Date November 02, 2018
Days to Decision 240 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.