Cleared Traditional

NeuroMatch

K250239 · LVIS Corporation · Neurology
May 2025
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K250239 is an FDA 510(k) clearance for the NeuroMatch, a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II — Special Controls, product code OLX), submitted by LVIS Corporation (Palo Alto, US). The FDA issued a Cleared decision on May 23, 2025, 116 days after receiving the submission on January 27, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K250239 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2025
Decision Date May 23, 2025
Days to Decision 116 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLX — Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization