Cleared Traditional

K233985 - TRIUX neo (NM27000N )

Also marketed or referenced as:
MEGreview (SW26241N-B)

K233985 is an FDA 510(k) clearance for TRIUX neo (NM27000N ), manufactured by Megin OY. The device is a Class 2 Neurology device with product code OLX cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K233985 · Megin OY · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
149d
Days
Class 2
Risk

K233985 is an FDA 510(k) clearance for the TRIUX™ neo (NM27000N ). Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Megin OY (Espoo, FI). The FDA issued a Cleared decision on May 15, 2024 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Megin OY devices

FDA 510(k) Submission Details - K233985

510(k) Number K233985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2023
Decision Date May 15, 2024
Days to Decision 149 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 148d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLX Device Classification - Class 2, Special Controls

Product Code OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization
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 Neurology devices follow this clearance model.

Regulatory Peers - OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph

All 7
Devices cleared under the same product code (OLX) and FDA review panel - the closest regulatory comparables to K233985.
PreOp v3
K252565 · Clouds of Care · Feb 2026
NeuroMatch
K250239 · LVIS Corporation · May 2025
Sourcerer
K241513 · Brain Electrophysiology Laboratory Company, LLC · Sep 2024
RICOH MEG
K210199 · Ricoh Company, Ltd. · Jul 2021
EZTrack
K201910 · Neurologic, LLC · Dec 2020
PreOp
K172858 · Epilog · Jan 2018