Eyetracker/IDEAS
510(k) K070670
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070670 | Date18 Sep 2007 | StatusActive |
Official records
- FDA 510(k) database K070670
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GWN
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1460
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Eyetracker/IDEAS is a nystagmograph, a device designed to record and analyze eye movements. It is classified under the device type Nystagmograph and is intended for use in neurology to assess ocular motility, including horizontal and vertical eye movements, which may aid in diagnosing vestibular or neurological disorders.
This device is supplied as a reusable medical instrument and is cleared for use in clinical settings. It operates under FDA 510(k) clearance (K070670) as a Class 2 Neurology device, adhering to regulatory standards for diagnostic equipment. The Eyetracker/IDEAS is not MRI-safe, and its specifications include multiple registration numbers (e.g., 3005581270) under the product code GWN. Storage and handling follow standard medical device protocols to ensure accuracy and reliability.
Devices cleared under K070670
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Instrumentation Difra Ideas III | 22315 / Ideas III | B516223150 | — | On the market |
| Instrumentation Difra NysStar I | 22128 / NysStar I | B516221280 | — | On the market |
| Instrumentation Difra NysStar II | 22134 / NysStar II | B516221340 | — | On the market |
| Instrumentation Difra NysStar II with VOR | 22221 / NysStar II with VOR | B516222210 | — | On the market |
| Instrumentation Difra SA HeadStar V2.0 | 32098 / HeadStar V2.0 | B516320980 | — | On the market |
| Instrumentation Difra SA HeadStar V3.0 | 32595 / HeadStar V3.0 | B516325950 | — | On the market |
| Instrumentation Difra SA HeadStar V3.0 | 32629 / HeadStar V3.0 | B516326290 | — | On the market |
| Instrumentation Difra SA HeadStar V3.0 | 32638 / HeadStar V3.0 | B516326380 | — | On the market |
| Instrumentation Difra SA NysStar II | 30864 / NysStar II | B516308640 | — | On the market |
| Instrumentation Difra SA NysStar II with VOR | 31179 / NysStar II with VOR | B516311790 | — | On the market |
| Instrumentation Difra SA NysStar PRO | 32727 / NysStar PRO | B516327270 | — | On the market |
| Instrumentation Difra SA VestiView | 32975 / VestiView | B516329750 | — | On the market |
| Intrumentation Difra HeadStar | 22135 / HeadStar | B516221350 | — | On the market |
Similar devices
Other devices filed under FDA product code GWN (Nystagmograph).
- DDAT OMT by Ddat(Uk), Ltd.
- ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM by Ics Medical Corp.
- VNG VIDEO-SCOPE WIRELESS 11447 by INVENTIS SRL
- Synapsys VHIT Basic 10738 by INVENTIS SRL
- VARIOUS ELECTRODES by Bio-Logic Systems Corp.
- ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER by Ics Medical Corp.
- Synapsys Ulmer Video Nystagmograph by Synapsys, Inc.
- DizzyDoctor System 1.0.0 by Dizzydoctor Systems, LLC
- NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM by Ototronix, LLC
- CHRONOS VISION EYE TRACKING DEVICE (C-ETD) by Chronos Vision