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) → OLT — Non-Normalizing Quantitative Electroencephalograph Software # OLT · Non-Normalizing Quantitative Electroencephalograph Software _Neurology · 21 CFR 882.1400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT ## Overview - **Product Code:** OLT - **Device Name:** Non-Normalizing Quantitative Electroencephalograph Software - **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 54) Showing 20 most recent of 54 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251881](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K251881.md) | HippoMind (v1.0) | Hippoclinic | Dec 3, 2025 | SESE | | [K251366](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K251366.md) | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | Nihon Kohden Corporation | Oct 9, 2025 | SESE | | [K240593](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K240593.md) | VEEGix EEG System | NeuroServo, Inc. | Aug 23, 2024 | SESE | | [K220254](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K220254.md) | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft , Ltd. | Nov 30, 2022 | SESE | | [K213299](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K213299.md) | Wireless EEG System | Pascall Systems, Inc. | May 11, 2022 | SESE | | [K191322](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K191322.md) | E-EEGX, N-EEGX | GE Healthcare Finland Oy | Jan 22, 2020 | SESE | | [K192572](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K192572.md) | CNS Envision | Moberg Research, Inc. | Dec 17, 2019 | SESE | | [K190760](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K190760.md) | Cadwell Bolt Software | Cadwell Industries, Inc. | Nov 23, 2019 | SESE | | [K143487](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K143487.md) | Lifelines iEEG | Kvikna Ehf | Aug 21, 2015 | SESE | | [K142834](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K142834.md) | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | Jun 23, 2015 | SESE | | [K133995](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K133995.md) | NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE | Neurosoft , Ltd. | Jun 19, 2015 | SESE | | [K142064](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K142064.md) | GALILEO NT | Eb Neuro S.P.A. | Feb 13, 2015 | SESE | | [K141316](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K141316.md) | COGNISION EEG/EP SYSTEM | Neuronetrix Solutions | Feb 13, 2015 | SESE | | [K131882](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K131882.md) | GEODESICEEG SYSTEM 400 SERIES (GES 400) | Electrical Geodesics, Inc. | Feb 12, 2014 | SESE | | [K123665](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K123665.md) | LIFELINES IEEG | Kvikna Ehf | Mar 25, 2013 | SESE | | [K091963](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K091963.md) | VIGILANT EEG MONITOR, VIGILANT 2.0 | Infinite Biomedical Technologies, LLC | Nov 6, 2009 | SESE | | [K082886](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K082886.md) | ZOOM-100DC | Brainscope Company, Inc. | Aug 10, 2009 | SESE | | [K080546](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K080546.md) | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | Nihon Kohden America, Inc. | Aug 29, 2008 | SESE | | [K072382](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K072382.md) | MODEL I-2000 MONITOR | Infinite Biomedical Technologies | Feb 15, 2008 | SESE | | [K063797](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT/K063797.md) | GEODESIC EEG SYSTEM 300 | Electrical Geodesics, Incorporated | Jan 25, 2007 | SESE | ## Top Applicants - Aspect Medical Systems, Inc. — 2 clearances - Brainz Instruments , Ltd. — 2 clearances - Kvikna Ehf — 2 clearances - Medelec , Ltd. — 2 clearances - Neuro Scan Labs — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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