Cleared Abbreviated

K180601 - Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) (FDA 510(k) Clearance)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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

K180601 is an FDA 510(k) clearance for the Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under.... Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Villa Sistemi Medicali S.P.A. (Buccinasco, IT). The FDA issued a Cleared decision on November 2, 2018 after a review of 240 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

Submission Details

510(k) Number K180601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 128d · This submission: 240d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OAS X-ray, Tomography, Computed, Dental

All 25
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K180601.
myray ProXIma X6
K252353 · Cefla S.C. · Mar 2026
Primevision 3D
K253959 · Dentsply Sirona · Feb 2026
RCT700
K251798 · Ray Co., Ltd. · Nov 2025
Dental Computed Tomography X-ray System
K251842 · Fussen Technology Co., Ltd. · Nov 2025
GT300
K250060 · Genoray Co., Ltd. · Oct 2025
Dental CBCT X-ray System
K251642 · Yian Medical Technology (Haining) Co., Ltd. · Jun 2025