Search Results
Found 1 results
510(k) Data Aggregation
K Number
K062015Device Name
CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
Manufacturer
Date Cleared
2006-10-31
(106 days)
Product Code
Regulation Number
882.1460Why did this record match?
Applicant Name (Manufacturer) :
CHRONOS VISION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
Device Description
The Chronos Vision Eye Tracking Device (C-ETD) facilitates measurement of three-dimensional eye movements and head movement (rotation and translation). It is a basic instrument for many types of vestibulo-oculomotor and visual research functions. The Eye Tracking Device will be used in combination with appropriate stimulus generators (rotating or translating devices, visual displays).
Ask a Question
Ask a specific question about this device
Page 1 of 1