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OLT

55 FDA 510(k) clearances · Product code

160 daysmedian time to decision
303 days90th percentile
55clearances measured

FDA profile

Official device name
Non-Normalizing Quantitative Electroencephalograph Software
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Medical specialty
Neurology
Flags
Third-party review eligible
FDA definition
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
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RecordFirmDate
UB ERP System (K253767)Universal Brain2026-06-30
HippoMind (v1.0) (K251881)Hippoclinic2025-12-03
EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) (K251366)Nihon Kohden Corporation2025-10-09
VEEGix EEG System (K240593)NeuroServo, Inc.2024-08-23
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (K220254)Neurosoft , Ltd.2022-11-30
Wireless EEG System (K213299)Pascall Systems, Inc.2022-05-11
E-EEGX, N-EEGX (K191322)GE Healthcare Finland Oy2020-01-22
CNS Envision (K192572)Moberg Research, Inc.2019-12-17
Cadwell Bolt Software (K190760)Cadwell Industries, Inc.2019-11-23
Lifelines iEEG (K143487)Kvikna Ehf2015-08-21
DiscoverEEG System, Model DE-401 (K142834)Neurowave Systems, Inc.2015-06-23
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE (K133995)Neurosoft , Ltd.2015-06-19
COGNISION EEG/EP SYSTEM (K141316)Neuronetrix Solutions2015-02-13
GALILEO NT (K142064)Eb Neuro S.P.A.2015-02-13
GEODESICEEG SYSTEM 400 SERIES (GES 400) (K131882)Electrical Geodesics, Inc.2014-02-12
LIFELINES IEEG (K123665)Kvikna Ehf2013-03-25
VIGILANT EEG MONITOR, VIGILANT 2.0 (K091963)Infinite Biomedical Technologies, LLC2009-11-06
ZOOM-100DC (K082886)Brainscope Company, Inc.2009-08-10
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A (K080546)Nihon Kohden America, Inc.2008-08-29
MODEL I-2000 MONITOR (K072382)Infinite Biomedical Technologies2008-02-15
GEODESIC EEG SYSTEM 300 (K063797)Electrical Geodesics, Incorporated2007-01-25
BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 (K062533)Neurovirtual USA, Inc.2006-12-22
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. (K051883)GE Healthcare2005-08-05
BRM2 BRAIN MONITOR (K033010)Brainz Instruments , Ltd.2003-10-10
BRM2 BRAIN MONITOR (K030489)Brainz Instruments , Ltd.2003-05-02
NUAMPS (K023536)Neuroscan2003-01-15
SCAN LT40 (40 CHANNELS) (K001564)Neuro Scan Labs2000-11-24
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS) (K001324)Neuro Scan Labs2000-07-11
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES (K000892)Datex-Ohmeda, Inc.2000-06-16
COMPUMEDICS E-SERIES EEG SYSTEM (K000068)Compumedics Neuro Science Pty , Ltd.2000-03-13
SIEMENS INFINITY EEG POD (K991012)Siemens Medical Solutions USA, Inc.1999-06-24
LUNA (K982351)Stellate Systems1998-07-29
ECLIPSE VERSION 3.0 (K955577)Stellate Systems1996-09-20
DG PORTABLE SYSTEM (K954157)Medelec , Ltd.1996-01-17
A-1050 EEG MONITOR (K952347)Aspect Medical Systems, Inc.1996-01-16
DG EXAMINER PLUS (K953799)Medelec , Ltd.1995-11-08
QUANTITATIVE EEG ANALYSIS SOFTWARE (K951724)Neuroconcepts, Inc.1995-07-14
BRAINTRACE (K940811)Brainstorms Monitoring Corp.1995-05-02
NEUROSEARCH-24 OR NRS-24 (K915820)Lexicor Medical Technology, Inc.1995-02-08
TOPOGRAPHIC BRAIN MAPPING OPTION (K934050)Biosound, Inc.1994-02-03
SPECTRAL EEG MONITOR MODEL A1000 (K923043)Aspect Medical Systems, Inc.1992-12-03
SPECTRAL EEG MONITOR MODEL B500 (K913051)Biometrak Corp.1991-08-20
TECA NEUROMAPPER 386 (K894889)Teca, Inc.1989-12-22
TECA NEUROMAPPER 1620, BRAIN MAPPER (K894088)Teca, Inc.1989-11-15
GUARDIAN, EEG BRAIN MONITORING SYSTEM (K874733)Tracor Northern, Inc.1988-02-29
HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM (K863783)Hzi Research Center1987-03-03
QUANTIMAP III (K863650)Quantified Signal Imaging, Inc.1986-09-26
MIND MAP (20 CHANNEL EEG) (K860378)Mind Systems Corp.1986-08-12
CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS (K853420)Alvar1986-02-07
CDSA(COLOR DENSITY, SPECTRAL ARRRAY) (K852587)Tracor Northern, Inc.1985-08-16
SLEEP STAGER (K850541)Oxford Medilog, Inc.1985-08-02
DUAL CHENNEL BRAIN ACTIVITY MONITOR (K843808)Datex Division Instrumentarium Corp.1984-11-08
LIFESCAN EEG MONITOR (K841790)Neurometrics1984-07-12
OTE BIOMEDICA BERG FOURIER ANALYZER (K820653)Del Mar Avionics1982-05-07
ELECTROENCEPHALOMYOGRAPH (K810359)Thoracel Research Labs.1981-03-13

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