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/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/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](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K252565.md) | PreOp v3 | Clouds of Care | Feb 13, 2026 | SESE | | [K250239](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K250239.md) | NeuroMatch | LVIS Corporation | May 23, 2025 | SESE | | [K241513](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K241513.md) | Sourcerer | Brain Electrophysiology Laboratory Company, LLC | Sep 27, 2024 | SESE | | [K233985](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K233985.md) | TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY | May 15, 2024 | SESE | | [K210199](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K210199.md) | RICOH MEG | Ricoh Company, Ltd. | Jul 2, 2021 | SESE | | [K201910](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K201910.md) | EZTrack | Neurologic, LLC | Dec 22, 2020 | SESE | | [K172858](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K172858.md) | PreOp | Epilog | Jan 8, 2018 | SESE | | [K092844](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K092844.md) | GEOSOURCE | Electrical Geodesics, Inc. | Dec 21, 2010 | SESE | | [K100126](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K100126.md) | STELLATE GRIDVIEW | Excel-Tech Ltd. (Xltek) | Dec 3, 2010 | SESE | | [K091393](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K091393.md) | ELEKTA NEUROMAG WITH MAXFILTER | Elekta Neuromag OY | Oct 26, 2010 | SESE | | [K081430](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K081430.md) | ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING | Elekta Neuromag OY | Jul 28, 2008 | SESE | | [K070358](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K070358.md) | MAXINSIGHT | Eemagine Medical Imaging Solutions GmbH | Jul 30, 2007 | SESE | | [K050035](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K050035.md) | ELEKTA NEUROMAG WITH MAXWELL FILTER | Elekta Neuromag OY | Jan 25, 2005 | SESE | | [K041264](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K041264.md) | ELEKTA OY | Elekta Neuromag OY | Aug 10, 2004 | SESE | | [K040051](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K040051.md) | MEGVISION, MODEL EQ1000C SERIES | Eagle Technology, Inc. | Mar 24, 2004 | SESE | | [K030737](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K030737.md) | OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 | Ctf Systems (2001), Inc. | Oct 10, 2003 | SESE | | [K011241](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K011241.md) | NEUROSOFT'S SOURCE | Neurosoft, Inc. | Sep 19, 2001 | SESE | | [K001781](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K001781.md) | CURRY MULTIMODAL NEUROIMAGING SOFTWARE | Neurosoft, Inc. | Feb 5, 2001 | SESE | | [K002631](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/K002631.md) | ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG | Eemagine Medical Imaging Solutions GmbH | Oct 23, 2000 | SESE | | [K993708](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX/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/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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