Atlas FDA

GWN

60 FDA 510(k) clearances · Product code

115 daysmedian time to decision
273 days90th percentile
60clearances measured

FDA profile

Official device name
Nystagmograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1460
Medical specialty
Neurology
Flags
Third-party review eligible
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RecordFirmDate
SMARTVERTIGO™ Vestibular Assessment System (K260566)VertigoDx, Inc.2026-07-30
NeuroEars-Anna™ (K243709)Neuroears, Inc.2025-08-25
ICS Dizcovery (1091) (K242198)Natus Medical Denmark Aps2025-02-14
Synapsys VHIT (K242726)Inventis S.R.L.2025-01-03
NeuroSwift Pro (K223047)Neurobit Technologies Co., Ltd.2023-06-29
Insight Infrared Video Goggles (K203082)Vestibular First2020-11-12
VisualEyes (K200534)Interacoustics A/S2020-08-12
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph (K192186)Neurolign USA, LLC2019-11-29
RightEye Vision System (K181771)Righteye, LLC2018-09-28
DizzyDoctor System 1.0.0 (K182214)Dizzydoctor Systems, LLC2018-09-14
I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System (K181025)Neuro Kinetics, Inc.2018-07-24
I-Portal Portable Assessment System - Nystagmograph (I-PAS) (K171884)Neuro Kinetics, Inc.2017-11-22
ISEN-Goggles with Data Viewer (K163270)Isent Tech & Trading Company, Ltd.2017-09-25
VisualEyes (K163149)Interacoustics A/S2017-04-26
Synapsys Ulmer Video Nystagmograph (K163558)Synapsys SA2017-03-23
ISEN-Goggles (K152727)Isen Tech & Trading Company, Ltd.2016-04-26
EYE-SYNC (K152915)Syncthink, Inc.2016-01-29
VisualEyes (K152112)Interacoustics A/S2015-12-29
ICS Impulse (K151504)Gn Otometrics2015-11-16
I-Portal NOTC, VNG and VOG (K143607)Neuro Kinetics, Inc.2015-07-08
EYESEECAM VHIT (K131681)Interacoustics A/S2013-09-06
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM (K130201)Ototronix, LLC2013-04-26
ICS IMPULSE (K122550)Gn Otometrics2013-02-01
I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL (K083603)Neuro Kinetics2009-08-06
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM (K072254)Interacoustics A/S2008-02-05
EYETRACKER/IDEAS (K070670)S.A. Instrumentation Difra2007-09-18
BALANCEBACK MOBILE INTUITIVE VNG SYSTEM (K070729)Fall Prevention Technologies, LLC2007-03-30
CHRONOS VISION EYE TRACKING DEVICE (C-ETD) (K062015)Chronos Vision2006-10-31
FOCUS VNG/ENG TYPE 1068 (K061791)Gn Otometrics A/S2006-07-11
DDAT OMT (K050098)Ddat(Uk), Ltd.2005-05-23
BALANCEBACK VNG SYSTEM (K042529)Fall Prevention Technologies, LLC2004-10-06
ICS MEDICAL MODEL VG-30 VIDEO GOGGLES (K013060)Ics Medical2001-12-10
ENGPLUS (K010059)Western Systems Research, Inc.2001-02-27
EYETECT TREMOR MONITOR UNIT (TMU) (K003644)Eyetect, LLC2001-02-01
EXPRESSEYE (K992473)Optomotor Laboratories1999-08-12
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX (K991642)Bertec Corp.1999-08-03
ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM (K991497)Ics Medical Corp.1999-07-28
ULMER (VNG) VIDEO NYSTAGMOGRAPH (K982103)Synapsys, Inc.1998-09-11
ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER (K972631)Ics Medical Corp.1997-09-22
2D VOG - VIDEO-OCULOGRAPHY (K972243)Sensomotoric Instruments, GmbH1997-09-10
VIDEO EYE TRAKKER (K964646)Micromedical Technologies, Inc.1997-07-15
VISUALEYES: VIDEO EYE MONITOR (K964325)Micromedical Technologies, Inc.1997-07-15
VARIOUS ELECTRODES (K941928)Bio-Logic Systems Corp.1995-02-03
INFRARED EYE MOVEMENT MONITOR (K926312)Microguide, Inc.1994-12-15
HOUSE INFRARED/VIDEO ELECTRONYSTAGMOGRAPH SYSTEM (K925111)Eye Dynamics, Inc.1994-03-23
JANUS ATAC ENG ANALYSIS SYSTEM (K904385)Life-Tech Intl., Inc.1992-06-10
NICOLET NYSTAR PLUS SYSTEM (K884294)Nicolet Instrument Corp.1988-11-23
VESTIBULAR AUTOROTATION TEST (K871466)Western Systems Research, Inc.1987-07-24
COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE (K863424)Micromedical Technologies, Inc.1987-03-23
ELECTROCARDIOGRAPH CONTINUOUS MONITOR (K860457)Oxford Medilog, Inc.1986-04-30
NYSTAGMOGRAPH EOG/ENG ANALYSES (K851190)Nicolet Biomedical Instruments1985-11-27
ELECTRONYSTAGMOGRAPH (ENG RECORDER) (K850180)Bio-Logic Systems Corp.1985-07-22
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL (K842886)Teca, Inc.1984-12-12
SERVO MED NYSTAGMOGRAPH NG-1 (K843004)Servo Med, Inc.1984-10-30
PHILLY BOLTS (K834148)Philadelphia Medical Specialties1984-02-10
NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH (K822268)Kelleher Corp.1983-01-28
PHILLY BOLT ADULT PROCEDURE KIT (K823459)Philadelphia Medical Specialties1982-12-22
NAGASHIMA KN-52 SACCADE & PURSUIT STIM (K822266)Kelleher Corp.1982-08-16
PHILLY INFANT BOLT (K820151)Philadelphia Medical Specialties1982-01-28
LIFE-TECH #5102 VISULAB (K812180)Life-Tech Instruments, Inc.1981-08-21

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