# K991642: Eye Trak TM, Computerized Electronystagmograph (Eng), Model Etv-XXXX

- Pathway: 510(k) (Abbreviated)
- Applicant: Bertec Corp.
- Decided: Aug 3, 1999 after 82 days
- Product code: GWN (Nystagmograph)
- Device class: 2
- Regulation: 21 CFR 882.1460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EyeTrak™ is used to non-invasively measure the vertical and horizontal eye movements during a variety of tests performed during electronystagmography (ENG) testing. This testing includes, but is not limited to: saccadic test, smooth pursuit, optokinetic nystagmus, and kinetic vestibular tests. It provides a trained clinician with data and graphs representing a patient's ability to perform certain eye movements voluntarily, as well as the patient's involuntary eye movements due to head movement, eye movement and/or body movement as is normally performed in vestibular diagnostic testing such as in Hallpike positional tests. It is used, then, to aide in the detection and diagnosis of vestibular disorders. The EyeTrak™ does not incorporate a camera for vertical and horizontal eye movement measurement, therefore it is not as cumbersome as other similar devices, and does not have focal length and resolution limitations based on the camera and camera lens used. The EyeTrak™ instead measures horizontal and vertical eye movement non-invasively using infra-red sensors and an IR oculography method with background light suppression. This allows for direct transmission of sensor signals to a processing unit, which in turn provides the signals to the software for processing, saving, and presentation. A camera and monitor can be used to monitor torsional eye movements, and a sensor can be added to measure head movement. The results are used to provide documentation of a patient’s performance on specific tests.

Source page: https://510kreport.com/device/K991642
Methodology: https://510kreport.com/methodology