Search Results
Found 1 results
510(k) Data Aggregation
K Number
K991642Device Name
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
Manufacturer
Date Cleared
1999-08-03
(82 days)
Product Code
Regulation Number
882.1460Why did this record match?
Applicant Name (Manufacturer) :
BERTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EveTrak™ is used to non-invasively measure the vertical and horizontal eve 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 eve 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 results are used to provide documentation of a patient's performance on specific tests.
Device Description
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.
Ask a Question
Ask a specific question about this device
Page 1 of 1