VisionOne System
The VisionOne System is intended to facilitate perimetry visual field eye tests with the VisionOne medical device software running on a virtual reality (VR) headset to aid in the detection, diagnosis and monitoring of ocular and neurological diseases.
Basic Information
- Primary DI
- 07640255020694
- Basic UDI-DI Code
- 764025502TD016S22
- Reference
- 016.001.005
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
Additional Description
The VisionOne system allows perimetry visual field eye tests through a medical software applied with the help of a CE-marked virtual reality (VR) headset.
Medical Purpose
The VisionOne System is intended to facilitate perimetry visual field eye tests with the VisionOne medical device software running on a virtual reality (VR) headset to aid in the detection, diagnosis and monitoring of ocular and neurological diseases.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1212012001 | VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT |
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).