Atlas FDA

GWQ

189 FDA 510(k) clearances · Product code

107 daysmedian time to decision
285 days90th percentile
189clearances measured

FDA profile

Official device name
Full-Montage Standard Electroencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Medical specialty
Neurology
Flags
Third-party review eligible
FDA definition
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
Adverse events (MAUDE)
2020: 30 · 2021: 20 · 2022: 16 · 2023: 20 · 2024: 17 · 2026: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (K261604)Neuroelectrics Barcelona S.L.U.2026-06-13
New Wave System (K260455)Zeto, Inc.2026-03-13
Flexset System (K233403)Zeto, Inc.2024-04-30
Neuronaute Plus (K231366)Bioserenity Sas2023-11-09
Q21 (K221959)Neurofield, Inc.2023-08-31
SPARK Scan (K231457)Spark Neuro, Inc.2023-08-18
Cumulus Functional Neurophysiology Platform (K221963)Cumulus Neuroscience Limited2023-04-27
Okti (K230073)Compumedics Limited2023-02-09
Neuronaute with IceCap 2 & IceCap 2 Small (K223644)Bioserenity2023-01-12
iSyncWave (K220056)iMediSync, Inc.2022-08-10
Seer Home (K212788)Seer Medical Pty, Ltd.2022-06-16
WAVi SCAN EEG System and Accessories (K213900)Wavi Co.2022-05-06
NeuroAmp II, NeuroAmp II.5s (K193159)Corscience GmbH & Co. KG2020-12-30
Neuronaute (K202334)Bioserenity Sas2020-12-10
Cadwell Apollo System (K201819)Cadwell Industries, Inc.2020-09-29
Maxxi Position Sensor (K191492)Neurovirtual USA, Inc.2020-04-24
iCEWav Neuromonitoring Platform (K191868)Ice Neurosystems, Inc.2020-03-31
NeuralScan System (K192753)Medeia, Inc.2020-03-17
Cadwell Zenith System (K181466)Cadwell Industries, Inc.2018-09-01
Cadwell Apollo System (K180269)Cadwell Industries, Inc.2018-07-17
Natus Brain Monitor Amplifier (K180290)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-06-14
Trackit T4 EEG Amplifier (K172271)Lifelines , Ltd.2018-05-04
WR19 System (K172735)Zeto, Inc.2018-04-17
Natus Quantum (K180181)Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)2018-02-22
NeuroEEG (K173460)Memory MD, Inc.2018-02-16
Micromed BRAIN QUICK system (K171384)Micromed S.P.A.2018-02-01
NEURONAUTE (K170138)Bioserenity2017-12-26
eVox System (K171781)Evoke Neuroscience, Inc.2017-12-13
Nihon Kohden Wireless Input Unit WEE-1200 (K171124)Nihon Kohden Corporation2017-08-25
ElectroTek (K170441)Mobilemedtek2017-06-05
Enobio Wireless EEG (K162681)Neuroelectrics Barcelona S.L.U.2017-06-02
XLTEK EMU40EX EEG Headbox (K163163)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2016-12-14
Trex_HD (K162595)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2016-11-04
Discovery 24 (K150498)Brainmaster Technologies, Inc.2016-01-26
Mitsar-EEG (K143233)Mitsar Co., Ltd.2015-08-13
Natus Quantum (K143440)Natus Medical Incorporated2015-04-20
BWMINI EEG, BWMINIHST, BWMINI PSG (K131335)Neurovirtual USA, Inc.2015-02-03
TREZ_HD (K131266)Excel-Tech Ltd. (Xltek)2014-02-14
CADWELL FLEX EEG/PSG (K133355)Cadwell Industries, Inc.2014-01-29
X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE (K131383)Advanced Brain Monitoring, Inc.2013-11-27
CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY (K122196)Blackrock Neuromed, LLC2013-05-02
PSG-1100 SLEEP DIAGNOSTIC SYSTEM (K120888)Nihon Kohden Corp.2012-11-09
MICROEEG SYSTEM (K112817)Bio-Signal Group Corporation2012-06-19
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX (K113117)Nihon Kohden America, Inc.2012-03-22
GEODESIC EEG MOBILE 100 (GEM 100) (K112353)Electrical Geodesics, Inc.2012-02-17
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS (K112107)Neurovirtual USA, Inc.2011-10-28
HARMONIE SYSTEM (K083577)Stellate Systems2011-08-29
PE-210AK SWITCH BOX (K110376)Nihon Kohden Corp.2011-07-29
ENTROPY EASYFIT SENSOR (K103129)GE Healthcare2011-07-19
VIGILANT EEG MONITOR MODEL VIGILANT 2.0 (K101386)Infinite Biomedical Technologies, LLC2010-07-30
NEUROLINK IP MODEL: PK1117 (K100683)Natus Medical Incorporated2010-04-09
COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG (K093223)Compumedics Limited2010-01-15
NEUROLINK IP, MODEL PK1113 (K081741)Excel-Tech Ltd. (Xltek)2008-10-31
COMPUMEDICS NEUVO (K081151)Compumedics USA, Ltd.2008-09-08
SACS EEG WORKSTATION A7 (K071109)Sacs Medical AB2007-06-07
NICOLETONE SYSTEM V32 AMPLIFIER (K061908)Viasys Neuro Care2006-11-06
XLTEK EMU40 EEG HEADBOX, MODEL PK1072 (K053386)Excel Tech. , Ltd.2006-04-21
COGNITRACE (K051825)Eemagine Medical Imaging Solutions GmbH2005-09-12
NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM (K042626)Cyberkinetics, Inc.2005-03-28
GEODESIC PHOTOGRAMMETRY SYSTEM (K043309)Electrical Geodesics, Incorporated2005-01-26
XLTEK TREX MODEL#10309 (K042150)Excel Tech. , Ltd.2004-08-27
GEODESIC EEG SYSTEM SERIES 100 (K033399)Electrical Geodesics, Incorporated2004-08-04
ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 (K040554)Manufacturing Technology, Inc.2004-07-16
EMU128S, MODEL EX-NW-128S (K040360)Excel Tech. , Ltd.2004-03-12
ADAM (K033978)Astro-Med, Inc.2004-02-18
SYNAMPS2 (K023771)Neuroscan2003-02-06
EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION (K022785)Axon Systems, Inc.2002-10-09
96 CHANNEL EEG HEADBOX MODEL EMU96 (K021599)Excel Tech. , Ltd.2002-08-13
80 CHANNEL EEG (K014147)Xltek2002-01-14
84 CHANNEL EEG (K014146)Xltek2002-01-14
PAM-RL (K010997)Individual Monitoring Systems, Inc.2001-10-15
GEODESIC EEG SYSTEM, MODEL 200 (K012079)Electrical Geodesics, Incorporated2001-09-19
UNIQUE AMBULATORY EEG (K010697)Axon Systems, Inc.2001-06-06
NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 (K010669)Thuris Corp.2001-06-04
ACTIWARE-PLMS (K011430)Mini-Mitter Co., Inc.2001-05-31
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) (K010086)Excel Tech. , Ltd.2001-04-09
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) (K010088)Excel Tech. , Ltd.2001-03-26
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) (K010089)Excel Tech. , Ltd.2001-03-26
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP (K010084)Excel Tech. , Ltd.2001-03-16
64 CHANNEL EEG / MODEL NUMBER EX-NW-64 (K010150)Excel Tech. , Ltd.2001-02-09
EEG WITH VIDEO, MODEL EX-NW (K010091)Excel Tech. , Ltd.2001-02-01
PHOENIX DIGITAL EEG (K002316)Axon Systems, Inc.2000-10-26
BIO-LOGIC CEEGRAPH NETLINK (K002570)Bio-Logic Systems Corp.2000-09-14
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 (K000919)Excel Tech. , Ltd.2000-08-31
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) (K001103)Excel Tech. , Ltd.2000-06-30
EEG WITH VIDEO, MODEL EX-NW (K000898)Excel Tech. , Ltd.2000-04-14
BRAVO MULTI-MODALITY SYSTEM (K991054)Nicolet Biomedical, Inc.1999-11-03
ACTITRAC (K992410)Individual Monitoring Systems, Inc.1999-10-15
ACTIWATCH-SCORE (K991033)Mini-Mitter Co., Inc.1999-06-23
ACTIWATCH (K983533)Mini-Mitter Co., Inc.1999-03-23
EXCEL AMBULATORY EEG (K982479)Excel Tech. , Ltd.1998-10-14
EXCEL NEURO WORKS (K980214)Excel Tech. , Ltd.1998-04-21
BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM (K973883)Bio-Logic Systems Corp.1998-03-05
NEUROAMP EEG AMPLIFIER (K974495)Neurocorp, Ltd.1998-02-26
CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM) (K971329)Ctf Systems, Inc.1997-11-20
DEEG-LITE (K972202)Grass-Telefactor Product Group1997-07-23
SATELLITE (K971331)Nicolet Biomedical, Inc.1997-06-25
MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM (K970942)Physiometrix, Inc.1997-06-02
GALILEO HALLEY (K970703)Biosound Esaote, Inc.1997-05-19
DG NERVUS (K964280)Medelec , Ltd.1997-01-27
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