Cleared Traditional

K191719 - X-MIND Trium

K191719 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 MUH cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K191719 · De Gotzen S.R.L. · Radiology device
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Feb 2020
Decision
239d
Days
Class 2
Risk

K191719 is an FDA 510(k) clearance for the X-MIND Trium. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by De Gotzen S.R.L. (Olgiate Olona, IT). The FDA issued a Cleared decision on February 20, 2020 after a review of 239 days - an extended review 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all De Gotzen S.R.L. devices

FDA 510(k) Submission Details - K191719

510(k) Number K191719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2019
Decision Date February 20, 2020
Days to Decision 239 days
Submission Type Traditional
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
132d slower than avg
Panel avg: 107d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUH Device Classification - Class 2, Special Controls

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 152
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