DEVICE: Instrumentation Difra (B516222210)

Device Identifier (DI) Information

Instrumentation Difra
NysStar II with VOR
In Commercial Distribution
22221
Instrumentation Difra SA
B516222210
HIBCC

1
370173410 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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?
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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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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FDA Product Code

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Product Code Product Code Name
GWN Nystagmograph
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K070670 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

11e18246-6439-4d10-a521-4e8a4e4dadb0
July 06, 2018
3
May 19, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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