Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400) → OLX — Source Localization Software For Electroencephalograph Or Magnetoencephalograph

# OLX · Source Localization Software For Electroencephalograph Or Magnetoencephalograph

_Neurology · 21 CFR 882.1400 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/OLX

## Overview

- **Product Code:** OLX
- **Device Name:** Source Localization Software For Electroencephalograph Or Magnetoencephalograph
- **Regulation:** [21 CFR 882.1400](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1400)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 24)

Showing 20 most recent of 24 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252565](/device/K252565.md) | PreOp v3 | Clouds of Care | Feb 13, 2026 | SESE |
| [K250239](/device/K250239.md) | NeuroMatch | LVIS Corporation | May 23, 2025 | SESE |
| [K241513](/device/K241513.md) | Sourcerer | Brain Electrophysiology Laboratory Company, LLC | Sep 27, 2024 | SESE |
| [K233985](/device/K233985.md) | TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY | May 15, 2024 | SESE |
| [K210199](/device/K210199.md) | RICOH MEG | Ricoh Company, Ltd. | Jul 2, 2021 | SESE |
| [K201910](/device/K201910.md) | EZTrack | Neurologic, LLC | Dec 22, 2020 | SESE |
| [K172858](/device/K172858.md) | PreOp | Epilog | Jan 8, 2018 | SESE |
| [K092844](/device/K092844.md) | GEOSOURCE | Electrical Geodesics, Inc. | Dec 21, 2010 | SESE |
| [K100126](/device/K100126.md) | STELLATE GRIDVIEW | Excel-Tech Ltd. (Xltek) | Dec 3, 2010 | SESE |
| [K091393](/device/K091393.md) | ELEKTA NEUROMAG WITH MAXFILTER | Elekta Neuromag OY | Oct 26, 2010 | SESE |
| [K081430](/device/K081430.md) | ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING | Elekta Neuromag OY | Jul 28, 2008 | SESE |
| [K070358](/device/K070358.md) | MAXINSIGHT | Eemagine Medical Imaging Solutions GmbH | Jul 30, 2007 | SESE |
| [K050035](/device/K050035.md) | ELEKTA NEUROMAG WITH MAXWELL FILTER | Elekta Neuromag OY | Jan 25, 2005 | SESE |
| [K041264](/device/K041264.md) | ELEKTA OY | Elekta Neuromag OY | Aug 10, 2004 | SESE |
| [K040051](/device/K040051.md) | MEGVISION, MODEL EQ1000C SERIES | Eagle Technology, Inc. | Mar 24, 2004 | SESE |
| [K030737](/device/K030737.md) | OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 | Ctf Systems (2001), Inc. | Oct 10, 2003 | SESE |
| [K011241](/device/K011241.md) | NEUROSOFT'S SOURCE | Neurosoft, Inc. | Sep 19, 2001 | SESE |
| [K001781](/device/K001781.md) | CURRY MULTIMODAL NEUROIMAGING SOFTWARE | Neurosoft, Inc. | Feb 5, 2001 | SESE |
| [K002631](/device/K002631.md) | ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG | Eemagine Medical Imaging Solutions GmbH | Oct 23, 2000 | SESE |
| [K993708](/device/K993708.md) | BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG | Biomagnetic Technologies, Inc. | Dec 3, 1999 | SESE |

## Top Applicants

- Elekta Neuromag OY — 4 clearances
- Biomagnetic Technologies, Inc. — 3 clearances
- Eemagine Medical Imaging Solutions GmbH — 2 clearances
- Neurosoft, Inc. — 2 clearances
- Brain Electrophysiology Laboratory Company, LLC — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/OLX](https://fda.innolitics.com/productcode/OLX)

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