DEVICE: Intrumentation Difra (B516221350)
Device Identifier (DI) Information
Intrumentation Difra
HeadStar
In Commercial Distribution
22135
Instrumentation Difra SA
HeadStar
In Commercial Distribution
22135
Instrumentation Difra SA
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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11479 | Electronystagmograph |
A graphic recorder used for detecting the electrical potential caused by eye movements. This recorder includes an electrode for each eye and one on the forehead (multichannel recording) for measuring the potential from both eyes simultaneously, or repositioning of the electrodes before each test for single channel recording. Electronystagmographs are used for detecting multiple sclerosis, vestibular dysfunctions, the presence of drugs and other specific disorders characterized by involuntary eye movement (nystagmus).
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FDA Product Code
[?]Product Code | Product Code Name |
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GWN | Nystagmograph |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K070670 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
5ee02e8c-451d-493b-9b1b-629f82d0a0d9
July 06, 2018
3
May 19, 2017
July 06, 2018
3
May 19, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Unit of Use DI
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined