Instrumentation Difra SA 32098

GUDID B516320980

The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. HEADSTAR is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus), the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests and the Video Head Impulse Test. HEADSTAR is a nystagmography system and is able to record movements of one eye: horizontal, vertical and rotary on option. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. HEADSTAR is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run VHIT tests and other oculomotor tests.

Instrumentation Difra SA

Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph Electronystagmograph

• Primary Device ID: B516320980
• NIH Device Record Key: ee6548e3-a111-4f6f-98d5-86a3790e7d76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrumentation Difra SA
• Version Model Number: HeadStar V2.0
• Catalog Number: 32098
• Company DUNS: 370173410
• Company Name: Instrumentation Difra SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B516320980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070670

FDA Product Code

• GWN: Nystagmograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-08
• Device Publish Date: 2024-01-31

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• B516310120: The air caloric stimulator is a device that delivers a stream of air to the ear canal at control
• B516311790: The videonystagmography performed by a camera and infra red light measures and records the eye m
• B516320980: The videonystagmography performed by a camera and infra red light measures and records the eye m