Cleared Abbreviated

K111152 - ROTOGRAPH EVO 3D (FDA 510(k) Clearance)

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

K111152 · Villa Sistemi Medicali S.P.A. · Radiology device
Jul 2011
Decision
88d
Days
Class 2
Risk

K111152 is an FDA 510(k) clearance for the ROTOGRAPH EVO 3D. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Villa Sistemi Medicali S.P.A. (Buccinasco, IT). The FDA issued a Cleared decision on July 22, 2011 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 K111152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2011
Decision Date July 22, 2011
Days to Decision 88 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - MUH System, X-ray, Extraoral Source, Digital

All 11
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