Instrumentation Difra SA 32629

GUDID B516326290

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
Primary Device IDB516326290
NIH Device Record Keyb1aab78d-3fdc-4cff-8a9f-68dbd7f6914b
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstrumentation Difra SA
Version Model NumberHeadStar V3.0
Catalog Number32629
Company DUNS370173410
Company NameInstrumentation Difra SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB516326290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWNNystagmograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-20
Device Publish Date2025-03-12

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B516311790The videonystagmography performed by a camera and infra red light measures and records the eye m
B516320980The videonystagmography performed by a camera and infra red light measures and records the eye m
B516308640The videonystagmography performed by a camera and infra red light measures and records the eye m
B516326380The videonystagmography performed by a camera and infra red light measures and records the eye m
B516326290The videonystagmography performed by a camera and infra red light measures and records the eye m
B516325950The videonystagmography performed by a camera and infra red light measures and records the eye m

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