Nystagmograph
FDA product code GWN · Class II (moderate risk) · 21 CFR 882.1460 · Neurology
60510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Interacoustics A/S 5
- Neuro Kinetics, Inc. 4
- Philadelphia Medical Specialties 3
- Ics Medical Corp. 3
- Micromedical Technologies, Inc. 3
- Fall Prevention Technologies, LLC 2
- Synapsys, Inc. 2
- Gn Otometrics 2
- Western Systems Research, Inc. 2
- Bio-Logic Systems Corp. 2
- Kelleher Corp. 2
- VertigoDx, Inc. 1
- Nicolet Instrument Corp. 1
- Life-Tech Intl., Inc. 1
- Eye Dynamics, Inc. 1
- Microguide, Inc. 1
- Nicolet Biomedical Instruments 1
- Teca, Inc. 1
- Bertec Corp. 1
- Servo Med, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260566 | SMARTVERTIGO Vestibular Assessment SystemGWN · Traditional | VertigoDx, Inc. | 07/30/2026SE |
| K243709 | NeuroEars-AnnaGWN · Traditional | Neuroears, Inc. | 08/25/2025SE |
| K242198 | ICS Dizcovery (1091)GWN · Traditional | Natus Medical Denmark Aps | 02/14/2025SE |
| K242726 | Synapsys VHITGWN · Traditional | Inventis S.R.L. | 01/03/2025SE |
| K223047 | NeuroSwift ProGWN · Traditional | Neurobit Technologies Co., Ltd. | 06/29/2023SE |
| K203082 | Insight Infrared Video GogglesGWN · Traditional | Vestibular First | 11/12/2020SE |
| K200534 | VisualEyesGWN · Traditional | Interacoustics A/S | 08/12/2020SE |
| K192186 | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal…GWN · Traditional | Neurolign USA, LLC | 11/29/2019SE |
| K181771 | RightEye Vision SystemGWN · Traditional | Righteye, LLC | 09/28/2018SE |
| K182214 | DizzyDoctor System 1.0.0GWN · Traditional | Dizzydoctor Systems, LLC | 09/14/2018SE |
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal…GWN · Special | Neuro Kinetics, Inc. | 07/24/2018SE |
| K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS)GWN · Traditional | Neuro Kinetics, Inc. | 11/22/2017SE |
| K163270 | ISEN-Goggles with Data ViewerGWN · Traditional | Isent Tech & Trading Company, Ltd. | 09/25/2017SE |
| K163149 | VisualEyesGWN · Traditional | Interacoustics A/S | 04/26/2017SE |
| K163558 | Synapsys Ulmer Video NystagmographGWN · Special | Synapsys SA | 03/23/2017SE |
| K152727 | ISEN-GogglesGWN · Traditional | Isen Tech & Trading Company, Ltd. | 04/26/2016SE |
| K152915 | Eye-SyncGWN · Traditional | Syncthink, Inc. | 01/29/2016SE |
| K152112 | VisualEyesGWN · Traditional | Interacoustics A/S | 12/29/2015SE |
| K151504 | ICS ImpulseGWN · Traditional | Gn Otometrics | 11/16/2015SE |
| K143607 | I-Portal NOTC, VNG and VOGGWN · Traditional | Neuro Kinetics, Inc. | 07/08/2015SE |
| K131681 | Eyeseecam VhitGWN · Traditional | Interacoustics A/S | 09/06/2013SE |
| K130201 | Nystagram Video Nystagmography SystemGWN · Traditional | Ototronix, LLC | 04/26/2013SE |
| K122550 | Ics ImpulseGWN · Traditional | Gn Otometrics | 02/01/2013SE |
| K083603 | I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography…GWN · Traditional | Neuro Kinetics | 08/06/2009SE |
| K072254 | VN415M, VN415B, VO425M, V0425B, 2D-VOG Goggles, 2D-VOG SystemGWN · Traditional | Interacoustics A/S | 02/05/2008SE |
| K070670 | Eyetracker/IdeasGWN · Traditional | S.A. Instrumentation Difra | 09/18/2007SE |
| K070729 | Balanceback Mobile Intuitive VNG SystemGWN · Traditional | Fall Prevention Technologies, LLC | 03/30/2007SE |
| K062015 | Chronos Vision Eye Tracking Device (C-Etd)GWN · Traditional | Chronos Vision | 10/31/2006SE |
| K061791 | Focus Vng/Eng Type 1068GWN · Traditional | Gn Otometrics A/S | 07/11/2006SE |
| K050098 | Ddat OmtGWN · Traditional | Ddat(Uk), Ltd. | 05/23/2005SE |
| K042529 | Balanceback VNG SystemGWN · Traditional | Fall Prevention Technologies, LLC | 10/06/2004SE |
| K013060 | Ics Medical Model VG-30 Video GogglesGWN · Traditional | Ics Medical | 12/10/2001SE |
| K010059 | EngplusGWN · Traditional | Western Systems Research, Inc. | 02/27/2001SE |
| K003644 | Eyetect Tremor Monitor Unit (Tmu)GWN · Traditional | Eyetect, LLC | 02/01/2001SE |
| K992473 | ExpresseyeGWN · Traditional | Optomotor Laboratories | 08/12/1999SE |
| K991642 | Eye Trak TM, Computerized Electronystagmograph (Eng), Model Etv-XxxxGWN · Abbreviated | Bertec Corp. | 08/03/1999SE |
| K991497 | Ics Medical Chartr Eng/Vng Diagnostic SystemGWN · Traditional | Ics Medical Corp. | 07/28/1999SE |
| K982103 | Ulmer (VNG) Video NystagmographGWN · Traditional | Synapsys, Inc. | 09/11/1998SE |
| K972631 | Ics Medical Vemr Video Eye Movement RecorderGWN · Traditional | Ics Medical Corp. | 09/22/1997SE |
| K972243 | 2D Vog - Video-OculographyGWN · Traditional | Sensomotoric Instruments, GmbH | 09/10/1997SE |
| K964646 | Video Eye TrakkerGWN · Traditional | Micromedical Technologies, Inc. | 07/15/1997SE |
| K964325 | Visualeyes: Video Eye MonitorGWN · Traditional | Micromedical Technologies, Inc. | 07/15/1997SE |
| K941928 | Various ElectrodesGWN · Traditional | Bio-Logic Systems Corp. | 02/03/1995SE |
| K926312 | Infrared Eye Movement MonitorGWN · Traditional | Microguide, Inc. | 12/15/1994SE |
| K925111 | House Infrared/Video Electronystagmograph SystemGWN · Traditional | Eye Dynamics, Inc. | 03/23/1994SE |
| K904385 | Janus Atac Eng Analysis SystemGWN · Traditional | Life-Tech Intl., Inc. | 06/10/1992SE |
| K884294 | Nicolet Nystar Plus SystemGWN · Traditional | Nicolet Instrument Corp. | 11/23/1988SE |
| K871466 | Vestibular Autorotation TestGWN · Traditional | Western Systems Research, Inc. | 07/24/1987SE |
| K863424 | Computer Eye Tracking Sys./Eng Exam. Chair & TableGWN · Traditional | Micromedical Technologies, Inc. | 03/23/1987SE |
| K860457 | Electrocardiograph Continuous MonitorGWN · Traditional | Oxford Medilog, Inc. | 04/30/1986SE |
| K851190 | Nystagmograph Eog/Eng AnalysesGWN · Traditional | Nicolet Biomedical Instruments | 11/27/1985SE |
| K850180 | Electronystagmograph (Eng Recorder)GWN · Traditional | Bio-Logic Systems Corp. | 07/22/1985SE |
| K842886 | Teca MS-20 Mystro ElectrophysiologicalGWN · Traditional | Teca, Inc. | 12/12/1984SE |
| K843004 | Servo Med Nystagmograph NG-1GWN · Traditional | Servo Med, Inc. | 10/30/1984SE |
| K834148 | Philly BoltsGWN · Traditional | Philadelphia Medical Specialties | 02/10/1984SE |
| K822268 | Nagashima Ns-Iii ElectronystagmographGWN · Traditional | Kelleher Corp. | 01/28/1983SE |
| K823459 | Philly Bolt Adult Procedure KitGWN · Traditional | Philadelphia Medical Specialties | 12/22/1982SE |
| K822266 | Nagashima KN-52 Saccade & Pursuit StimGWN · Traditional | Kelleher Corp. | 08/16/1982SE |
| K820151 | Philly Infant BoltGWN · Traditional | Philadelphia Medical Specialties | 01/28/1982SE |
| K812180 | Life-Tech #5102 VisulabGWN · Traditional | Life-Tech Instruments, Inc. | 08/21/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2730-2015 Class II | Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary…The devices that included the OVAR research test were not cleared for marketing and mTBI research package… | Neuro Kinetics, Inc. | 07/21/2015Terminated |
| Z-1795-2015 Class II | I-Portal NOTC and VNG; a device used to measure, record, or visually display the…complaints of system malfunction and unintended, sudden movement at start up. No injuries reported. | Neuro Kinetics, Inc. | 04/30/2015Terminated |
| Z-2072-2014 Class II | Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's.…Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised… | Integra LifeSciences Corp. | 07/09/2014Terminated |
| Z-0966-2014 Class II | Normative Data Template CD for use with the I-Portal devices. Used to measure, record…The data provided on the Normative Data Template CD for use with the I-Portal devices has not received… | Neuro Kinetics, Inc. | 11/21/2013Terminated |