Cleared Abbreviated

K180601 - Rotograph Prime 3D (under Trade mark Vi...

K180601 is the FDA 510(k) clearance for Rotograph Prime 3D (under Trade mark Vi... by Villa Sistemi Medicali S.P.A.. It is a Class 2 Radiology device (product code OAS) cleared through the Abbreviated 510(k) pathway after a 240-day FDA review.

K180601 · Villa Sistemi Medicali S.P.A. · Radiology device
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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.

View all Villa Sistemi Medicali S.P.A. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 107d · 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.