DEVICE: Instrumentation Difra (B516227090)
Device Identifier (DI) Information
Instrumentation Difra
NysStar II with VOR
In Commercial Distribution
22709
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution
22709
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. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. 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. NYSSTAR IU 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 specific 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. 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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Active | false |
45584 | Dynamic visual acuity testing system |
An assembly of devices used to track changes in visual acuity during head movements primarily to quantify visual acuity loss due to vestibular pathology. The assembly typically includes a three-dimensional (3-D) integrating gyrometer (or equivalent) fastened to the patient's head, a connected personal computer used to track the patient's ability to correctly identify an image according to a specified head movement, a mounted monitor for image viewing, and operating system software. The system helps to identify patients most likely to benefit from vestibular rehabilitation exercises.
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Active | false |
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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Premarket Submission Number Not Available/Not Released |
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
8b0fc8a6-567b-4320-9c4a-3a998fe77e9f
May 26, 2020
1
May 18, 2020
May 26, 2020
1
May 18, 2020
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