456f4dc6-f015-4e4d-a066-671701402321UpdatePublished22024-12-112020-07-01In Commercial DistributionB818NOTC0PrimaryHIBCCB290NOTC0PreviousHIBCCNeurolign Dx NOTCDx NOTCDx NOTC119206320Spryson America, Inc.1NystagmographfalsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse46390Vision/eye movement analysis systemAn electronic unit or device assembly intended to measure, record, and display a range of parameters associated with vision electrophysiology [e.g., electroretinogram (ERG), visual evoked potential (VEP), electrooculogram (EOG)], and/or psychophysical vision (e.g., visual acuity/fields, refractive error, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation/screening. Features may include visual stimuli (e.g., patterns of light/images) and/or devices for sensing/tracking (e.g., bioelectric amplifiers, video or infrared cameras). It is intended to be used by a healthcare professional in a clinical setting.falseObsoleteGWNNystagmographfalsefalse