Cleared Abbreviated

K160166 - X-MIND trium

K160166 is an FDA 510(k) clearance for X-MIND trium, manufactured by De Gotzen S.R.L.. The device is a Class 2 Radiology device with product code OAS cleared through the Abbreviated 510(k) pathway after a 293-day FDA review.

K160166 · De Gotzen S.R.L. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
293d
Days
Class 2
Risk

K160166 is an FDA 510(k) clearance for the X-MIND trium. 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 15, 2016 after a review of 293 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

FDA 510(k) Submission Details - K160166

510(k) Number K160166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date November 15, 2016
Days to Decision 293 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
186d slower than avg
Panel avg: 107d · This submission: 293d
Pathway characteristics
Standards-based clearance path.

OAS Device Classification - Class 2, Special Controls

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 126
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K160166.
Green16/Green18 (Model: PHT-65LHS)
K170066 · VATECH Co., Ltd. · Jun 2017
ORTHOPANTOMOGRAPH OP 3D
K170813 · Palodex Group OY · Apr 2017
HYPERION X5
K161900 · Cefla S.C. · Dec 2016
i-CAT FLX V series / KaVo 3D eXam+ V series
K162085 · Imaging Sciences International · Nov 2016
PaX-i3D Green Premium (Model: PCT-90LH)
K160882 · VATECH Co., Ltd. · Oct 2016
Green Smart (Model: PHT-35LHS)
K162660 · VATECH Co., Ltd. · Oct 2016