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Panels › Neurology › Product code OLT · Class 2

Non-Normalizing Quantitative Electroencephalograph Software

Regulation 882.1400

4510(k)s in 12 months (57 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in OLT

Company510(k)sRecalls
Aspect Medical Systems, Inc.20
Brainz Instruments , Ltd.20
Electrical Geodesics, Inc.20
Infinite Biomedical Technologies20
Kvikna Ehf20
Medelec , Ltd.20
Neuro Scan Labs20
Neurosoft , Ltd.20
Pascall Systems, Inc.20
Stellate Systems20
Decided510(k)Device and applicantCode
Sep 16, 2026K261712Ceribell EEG Analysis Software
Ceribell, Inc.
OLT
Aug 19, 2026K254213Pascall Sensor Unit (PSU1)
Pascall Systems, Inc.
OLT
Jun 30, 2026K253767UB ERP System
Universal Brain
OLT
Dec 3, 2025K251881HippoMind (v1.0)
Hippoclinic
OLT
Oct 9, 2025K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
Nihon Kohden Corporation, JP
OLT
Aug 23, 2024K240593VEEGix EEG System
NeuroServo, Inc., CA
OLT
Nov 30, 2022K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
Neurosoft , Ltd., RU
OLT
May 11, 2022K213299Wireless EEG System
Pascall Systems, Inc.
OLT
Jan 22, 2020K191322E-EEGX, N-EEGX
GE Healthcare Finland Oy, FI
OLT
Dec 17, 2019K192572CNS Envision
Moberg Research, Inc.
OLT
Nov 23, 2019K190760Cadwell Bolt Software
Cadwell Industries, Inc.
OLT
Aug 21, 2015K143487Lifelines iEEG
Kvikna Ehf, IS
OLT
Jun 23, 2015K142834DiscoverEEG System, Model DE-401
Neurowave Systems, Inc.
OLT
Jun 19, 2015K133995NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
Neurosoft , Ltd., IT
OLT
Feb 13, 2015K142064GALILEO NT
Eb Neuro S.P.A.
OLT
Feb 13, 2015K141316COGNISION EEG/EP SYSTEM
Neuronetrix Solutions
OLT
Feb 12, 2014K131882GEODESICEEG SYSTEM 400 SERIES (GES 400)
Electrical Geodesics, Inc.
OLT
Mar 25, 2013K123665LIFELINES IEEG
Kvikna Ehf
OLT
Nov 6, 2009K091963VIGILANT EEG MONITOR, VIGILANT 2.0
Infinite Biomedical Technologies, LLC
OLT
Aug 10, 2009K082886ZOOM-100DC
Brainscope Company, Inc.
OLT
Aug 29, 2008K080546NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
Nihon Kohden America, Inc.
OLT
Feb 15, 2008K072382MODEL I-2000 MONITOR
Infinite Biomedical Technologies
OLT
Jan 25, 2007K063797GEODESIC EEG SYSTEM 300
Electrical Geodesics, Incorporated
OLT
Dec 22, 2006K062533BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524
Neurovirtual USA, Inc.
OLT
Aug 5, 2005K051883DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
GE Healthcare
OLT
Oct 10, 2003K033010BRM2 BRAIN MONITOR
Brainz Instruments , Ltd., NZ
OLT
May 2, 2003K030489BRM2 BRAIN MONITOR
Brainz Instruments , Ltd., NZ
OLT
Jan 15, 2003K023536NUAMPS
Neuroscan
OLT
Nov 24, 2000K001564SCAN LT40 (40 CHANNELS)
Neuro Scan Labs
OLT
Jul 11, 2000K001324SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
Neuro Scan Labs
OLT
Jun 16, 2000K000892DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
Datex-Ohmeda, Inc.
OLT
Mar 13, 2000K000068COMPUMEDICS E-SERIES EEG SYSTEM
Compumedics Neuro Science Pty , Ltd.
OLT
Jun 24, 1999K991012SIEMENS INFINITY EEG POD
Siemens Medical Solutions USA, Inc.
OLT
Jul 29, 1998K982351LUNA
Stellate Systems, CA
OLT
Sep 20, 1996K955577ECLIPSE VERSION 3.0
Stellate Systems, CA
OLT
Jan 17, 1996K954157DG PORTABLE SYSTEM
Medelec , Ltd., DE
OLT
Jan 16, 1996K952347A-1050 EEG MONITOR
Aspect Medical Systems, Inc.
OLT
Nov 8, 1995K953799DG EXAMINER PLUS
Medelec , Ltd., DE
OLT
Jul 14, 1995K951724QUANTITATIVE EEG ANALYSIS SOFTWARE
Neuroconcepts, Inc.
OLT
May 2, 1995K940811BRAINTRACE
Brainstorms Monitoring Corp.
OLT
Feb 8, 1995K915820NEUROSEARCH-24 OR NRS-24
Lexicor Medical Technology, Inc.
OLT
Feb 3, 1994K934050TOPOGRAPHIC BRAIN MAPPING OPTION
Biosound, Inc.
OLT
Dec 3, 1992K923043SPECTRAL EEG MONITOR MODEL A1000
Aspect Medical Systems, Inc.
OLT
Aug 20, 1991K913051SPECTRAL EEG MONITOR MODEL B500
Biometrak Corp.
OLT
Dec 22, 1989K894889TECA NEUROMAPPER 386
Teca, Inc.
OLT
Nov 15, 1989K894088TECA NEUROMAPPER 1620, BRAIN MAPPER
Teca, Inc.
OLT
Feb 29, 1988K874733GUARDIAN, EEG BRAIN MONITORING SYSTEM
Tracor Northern, Inc.
OLT
Mar 3, 1987K863783HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM
Hzi Research Center
OLT
Sep 26, 1986K863650QUANTIMAP III
Quantified Signal Imaging, Inc., CA
OLT
Aug 12, 1986K860378MIND MAP (20 CHANNEL EEG)
Mind Systems Corp.
OLT

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