Instrumentation Difra
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…
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.
Who Else Makes It
Concentrated in Guangdong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Isen Tech.&Trading Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| E-Business International Inc. | Shenzhen | Guangdong | Exporter | 2 |
| Huizhou Maxway Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Instrumentation Difra SA |
|---|---|
| FDA product code | GWN |
| Device type | Nystagmograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1460 |
| 510(k) | K070670 |
| Record published | 2020-05-18 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NysStar II with VOR | In distribution | |
| NysStar II | In distribution | |
| NysStar I | In distribution | |
| NysStar II with VOR | In distribution | |
| VIDEOSTAR | In distribution | |
| Ideas III | In distribution | |
| VIDEOSTAR II | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Otometrics A/S | Natus Medical Denmark ApS | 17 |
| Interacoustics | Interacoustics A/S | 15 |
| VNG | Inventis SRL | 9 |
| Instrumentation Difra SA | Instrumentation Difra SA | 8 |
| Nystagmograph | Medtronic PS Medical | 7 |
| Otometrics | Natus Medical Denmark ApS | 5 |
| Vestibular First | Vestibular First | 4 |
| Micromedical Technologies | Micromedical Technologies, Inc. | 3 |
| Complete Monocular wireless Smart Cam system with Xpress mask | Synapsys SA | 2 |
| Synapsys Vhit | Inventis SRL | 2 |
| EYE-Sync | Neurosync, Inc. | 2 |
| I-Portal Super VNG | N K I | 2 |
Showing 12 of 37. All products under Nystagmograph
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.