Device Dossier

Vision physiology/eye movement analysis system

Device Dossier for Vision physiology/eye movement analysis system (Vision physiology/eye movement analysis system, Class IIa, sponsor Sonic Equipment).…

Intended purpose

Videonystagmography devices are intended to provide information to assist in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. VNG testing evaluates nystagmus using a headset mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information can then be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for videonystagmography is five years of age and above.

TGA Public Summary