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NeuroMatch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250239

by LVIS Corporation

Identifiers

510(k) Number
K250239 FDA 510(k)
FDA Product Code
OLX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1400 FDA 510(k)
Regulation Number
882.1400 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

NeuroMatch is a source localization software for electroencephalograph or magnetoencephalograph. It is designed to decode brain networks and deliver visualizations of brain activity to assist in neurological diagnosis.

NeuroMatch is supplied as a software platform, available in both traditional and cloud-based SaaS formats. It is intended for use in clinical settings to review and interpret EEG data, supporting quicker and more comprehensive analysis. The device has received FDA 510(k) clearance under product code OLX and regulation number 882.1400.

Frequently asked questions

What is NeuroMatch used for?

NeuroMatch is a source localization software designed to decode brain networks and deliver visualizations of brain activity from electroencephalograph or magnetoencephalograph data to assist in neurological diagnosis.

How is NeuroMatch supplied and accessed?

NeuroMatch is supplied as a software platform available in both traditional and cloud-based SaaS formats, intended for use in clinical settings to review and interpret EEG data.

Is NeuroMatch a single-use or reusable device?

NeuroMatch is a software platform, so it is not a physical device with single-use or reuse limitations; it is accessed via license or subscription for ongoing clinical use.

What regulatory pathway was used for NeuroMatch?

NeuroMatch received FDA 510(k) clearance under product code OLX and regulation number 882.1400, with a decision of substantially equivalent based on traditional review.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: See The Invisible With NeuroMatch | LVIS Corporation, NeuroMatch EEG Software Platform | LVIS Corporation, NeuroMatchWeb, LVIS Corporation Unveils Cloud-Based Platform for EEG Diagnostics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
LVIS Corporation

Sources (1)

  • FDA 510(k) K250239 24 fields · synced Sep 27, 2026