Non-Normalizing Quantitative Electroencephalograph Software
FDA product code OLT · Class II (moderate risk) · 21 CFR 882.1400 · Neurology
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
56510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Teca, Inc. 2
- Neuro Scan Labs 2
- Brainz Instruments , Ltd. 2
- Stellate Systems 2
- Medelec , Ltd. 2
- Electrical Geodesics, Incorporated 2
- Aspect Medical Systems, Inc. 2
- Kvikna Ehf 2
- Infinite Biomedical Technologies, LLC 2
- Neurosoft, Inc. 2
- Tracor Northern, Inc. 2
- Pascall Systems, Inc. 2
- Hzi Research Center 1
- Mind Systems Corp. 1
- Biometrak Corp. 1
- Biosound, Inc. 1
- Brainstorms Monitoring Corp. 1
- Universal Brain 1
- Oxford Medilog, Inc. 1
- Neurometrics 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254213 | Pascall Sensor Unit (PSU1)OLT · Special | Pascall Systems, Inc. | 08/19/2026SE |
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| K251881 | HippoMind (v1.0)OLT · Traditional | Hippoclinic | 12/03/2025SE |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A…OLT · Traditional | Nihon Kohden Corporation | 10/09/2025SE |
| K240593 | VEEGix EEG SystemOLT · Traditional | NeuroServo, Inc. | 08/23/2024SE |
| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareOLT · Traditional | Neurosoft , Ltd. | 11/30/2022SE |
| K213299 | Wireless EEG SystemOLT · Traditional | Pascall Systems, Inc. | 05/11/2022SE |
| K191322 | E-Eegx, N-EegxOLT · Traditional | GE Healthcare Finland Oy | 01/22/2020SE |
| K192572 | CNS EnvisionOLT · Traditional | Moberg Research, Inc. | 12/17/2019SE |
| K190760 | Cadwell Bolt SoftwareOLT · Traditional | Cadwell Industries, Inc. | 11/23/2019SE |
| K143487 | Lifelines iEEGOLT · Traditional | Kvikna Ehf | 08/21/2015SE |
| K142834 | DiscoverEEG System, Model DE-401OLT · Traditional | Neurowave Systems, Inc. | 06/23/2015SE |
| K133995 | NEURON-SPECTRUM-4/P with Neuron-Spectrum.Net SoftwareOLT · Traditional | Neurosoft , Ltd. | 06/19/2015SE |
| K142064 | Galileo NTOLT · Traditional | Eb Neuro S.P.A. | 02/13/2015SE |
| K141316 | Cognision Eeg/Ep SystemOLT · Traditional | Neuronetrix Solutions | 02/13/2015SE |
| K131882 | Geodesiceeg System 400 Series (Ges 400)OLT · Traditional | Electrical Geodesics, Inc. | 02/12/2014SE |
| K123665 | Lifelines IeegOLT · Traditional | Kvikna Ehf | 03/25/2013SE |
| K091963 | Vigilant EEG Monitor, Vigilant 2.0OLT · Traditional | Infinite Biomedical Technologies, LLC | 11/06/2009SE |
| K082886 | ZOOM-100DCOLT · Traditional | Brainscope Company, Inc. | 08/10/2009SE |
| K080546 | Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200AOLT · Special | Nihon Kohden America, Inc. | 08/29/2008SE |
| K072382 | Model I-2000 MonitorOLT · Traditional | Infinite Biomedical Technologies | 02/15/2008SE |
| K063797 | Geodesic EEG System 300OLT · Special | Electrical Geodesics, Incorporated | 01/25/2007SE |
| K062533 | Bwii EEG Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524OLT · Traditional | Neurovirtual USA, Inc. | 12/22/2006SE |
| K051883 | Datex-Ohmeda S/5 EEG Module, E-Eeg and Datex-Ohmeda S/5 EEG Headbox, N-Eeg and…OLT · Special | GE Healthcare | 08/05/2005SE |
| K033010 | BRM2 Brain MonitorOLT · Traditional | Brainz Instruments , Ltd. | 10/10/2003SE |
| K030489 | BRM2 Brain MonitorOLT · Traditional | Brainz Instruments , Ltd. | 05/02/2003SE |
| K023536 | NuampsOLT · Abbreviated | Neuroscan | 01/15/2003SE |
| K001564 | Scan LT40 (40 Channels)OLT · Traditional | Neuro Scan Labs | 11/24/2000SE |
| K001324 | Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps (129-256 Channels)OLT · Traditional | Neuro Scan Labs | 07/11/2000SE |
| K000892 | Datex-Ohmeda EEG Module, M-Eeg and Datex-Ohmeda EEG Headbox, N-Eeg and AccessoriesOLT · Traditional | Datex-Ohmeda, Inc. | 06/16/2000SE |
| K000068 | Compumedics E-Series EEG SystemOLT · Traditional | Compumedics Neuro Science Pty , Ltd. | 03/13/2000SE |
| K991012 | Siemens Infinity EEG PodOLT · Traditional | Siemens Medical Solutions USA, Inc. | 06/24/1999SE |
| K982351 | LunaOLT · Special | Stellate Systems | 07/29/1998SE |
| K955577 | Eclipse Version 3.0OLT · Traditional | Stellate Systems | 09/20/1996SE |
| K954157 | DG Portable SystemOLT · Traditional | Medelec , Ltd. | 01/17/1996SE |
| K952347 | A-1050 EEG MonitorOLT · Traditional | Aspect Medical Systems, Inc. | 01/16/1996SE |
| K953799 | DG Examiner PlusOLT · Traditional | Medelec , Ltd. | 11/08/1995SE |
| K951724 | Quantitative EEG Analysis SoftwareOLT · Traditional | Neuroconcepts, Inc. | 07/14/1995SE |
| K940811 | BraintraceOLT · Traditional | Brainstorms Monitoring Corp. | 05/02/1995SE |
| K915820 | NEUROSEARCH-24 or NRS-24OLT · Traditional | Lexicor Medical Technology, Inc. | 02/08/1995SE |
| K934050 | Topographic Brain Mapping OptionOLT · Traditional | Biosound, Inc. | 02/03/1994SE |
| K923043 | Spectral EEG Monitor Model A1000OLT · Traditional | Aspect Medical Systems, Inc. | 12/03/1992SE |
| K913051 | Spectral EEG Monitor Model B500OLT · Traditional | Biometrak Corp. | 08/20/1991SE |
| K894889 | Teca Neuromapper 386OLT · Traditional | Teca, Inc. | 12/22/1989SE |
| K894088 | Teca Neuromapper 1620, Brain MapperOLT · Traditional | Teca, Inc. | 11/15/1989SE |
| K874733 | Guardian, EEG Brain Monitoring SystemOLT · Traditional | Tracor Northern, Inc. | 02/29/1988SE |
| K863783 | Hzi Ceeg/Ep System Software (Ceeg-Scan)TmOLT · Traditional | Hzi Research Center | 03/03/1987SE |
| K863650 | Quantimap IIIOLT · Traditional | Quantified Signal Imaging, Inc. | 09/26/1986SE |
| K860378 | Mind Map (20 Channel EEG)OLT · Traditional | Mind Systems Corp. | 08/12/1986SE |
| K853420 | Cartovar Brain Mapping ElectrodiagnosticsOLT · Traditional | Alvar | 02/07/1986SE |
| K852587 | Cdsa(Color Density, Spectral Arrray)OLT · Traditional | Tracor Northern, Inc. | 08/16/1985SE |
| K850541 | Sleep StagerOLT · Traditional | Oxford Medilog, Inc. | 08/02/1985SE |
| K843808 | Dual Chennel Brain Activity MonitorOLT · Traditional | Datex Division Instrumentarium Corp. | 11/08/1984SE |
| K841790 | Lifescan EEG MonitorOLT · Traditional | Neurometrics | 07/12/1984SE |
| K820653 | Ote Biomedica Berg Fourier AnalyzerOLT · Traditional | Del Mar Avionics | 05/07/1982SE |
| K810359 | ElectroencephalomyographOLT · Traditional | Thoracel Research Labs. | 03/13/1981SE |