Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1460](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1460) → GWN — Nystagmograph # GWN · Nystagmograph _Neurology · 21 CFR 882.1460 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN ## Overview - **Product Code:** GWN - **Device Name:** Nystagmograph - **Regulation:** [21 CFR 882.1460](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1460) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 59) Showing 20 most recent of 59 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243709](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K243709.md) | NeuroEars-Anna™ | Neuroears, Inc. | Aug 25, 2025 | SESE | | [K242198](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K242198.md) | ICS Dizcovery (1091) | Natus Medical Denmark Aps | Feb 14, 2025 | SESE | | [K242726](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K242726.md) | Synapsys VHIT | Inventis S.R.L. | Jan 3, 2025 | SESE | | [K223047](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K223047.md) | NeuroSwift Pro | Neurobit Technologies Co., Ltd. | Jun 29, 2023 | SESE | | [K203082](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K203082.md) | Insight Infrared Video Goggles | Vestibular First | Nov 12, 2020 | SESE | | [K200534](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K200534.md) | VisualEyes | Interacoustics A/S | Aug 12, 2020 | SESE | | [K192186](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K192186.md) | I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph | Neurolign USA, LLC | Nov 29, 2019 | SESE | | [K181771](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K181771.md) | RightEye Vision System | Righteye, LLC | Sep 28, 2018 | SESE | | [K182214](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K182214.md) | DizzyDoctor System 1.0.0 | Dizzydoctor Systems, LLC | Sep 14, 2018 | SESE | | [K181025](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K181025.md) | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System | Neuro Kinetics, Inc. | Jul 24, 2018 | SESE | | [K171884](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K171884.md) | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | Neuro Kinetics, Inc. | Nov 22, 2017 | SESE | | [K163270](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K163270.md) | ISEN-Goggles with Data Viewer | Isent Tech & Trading Company, Ltd. | Sep 25, 2017 | SESE | | [K163149](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K163149.md) | VisualEyes | Interacoustics A/S | Apr 26, 2017 | SESE | | [K163558](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K163558.md) | Synapsys Ulmer Video Nystagmograph | Synapsys SA | Mar 23, 2017 | SESE | | [K152727](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K152727.md) | ISEN-Goggles | Isen Tech & Trading Company, Ltd. | Apr 26, 2016 | SESE | | [K152915](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K152915.md) | EYE-SYNC | Syncthink, Inc. | Jan 29, 2016 | SESE | | [K152112](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K152112.md) | VisualEyes | Interacoustics A/S | Dec 29, 2015 | SESE | | [K151504](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K151504.md) | ICS Impulse | Gn Otometrics | Nov 16, 2015 | SESE | | [K143607](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K143607.md) | I-Portal NOTC, VNG and VOG | Neuro Kinetics, Inc. | Jul 8, 2015 | SESE | | [K131681](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN/K131681.md) | EYESEECAM VHIT | Interacoustics A/S | Sep 6, 2013 | SESE | ## Top Applicants - Interacoustics A/S — 5 clearances - Micromedical Technologies, Inc. — 3 clearances - Neuro Kinetics, Inc. — 3 clearances - Philadelphia Medical Specialties — 3 clearances - Bio-Logic Systems Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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