Cleared Abbreviated

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) (K201382) - FDA 510(k) Clearance

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

K201382 · De Gotzen S.R.L. · Radiology device
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Nov 2020
Decision
176d
Days
Class 2
Risk

K201382 is an FDA 510(k) clearance for the X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Ra.... Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by De Gotzen S.R.L. (Olgiate Olona, IT). The FDA issued a Cleared decision on November 18, 2020 after a review of 176 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 De Gotzen S.R.L. devices

Submission Details

510(k) Number K201382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2020
Decision Date November 18, 2020
Days to Decision 176 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
69d slower than avg
Panel avg: 107d · This submission: 176d
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

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