Cleared Abbreviated

K162190 - Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (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.

K162190 · Villa Sistemi Medicali S.P.A. · Radiology device
Jul 2017
Decision
336d
Days
Class 2
Risk

K162190 is an FDA 510(k) clearance for the Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade.... 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 6, 2017 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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 K162190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2016
Decision Date July 06, 2017
Days to Decision 336 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 128d · This submission: 336d
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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