{"product_name":"RightEye Vision System","company_name":"RightEye","product_url":"https://righteye.com/righteye-visiontracker2/","company_url":"https://righteye.com/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0581","summary":"RightEye Vision System is an FDA-cleared eye-tracking device designed to identify visual tracking impairments and support various health assessments.","description":"The RightEye Vision System utilizes advanced eye-tracking technology to record, view, and analyze eye movements, aiding in the detection of visual tracking impairments and supporting assessments in functional vision, reading proficiency, sports vision, and brain health. It includes the RightEye VisionTracker2 device, a portable, lightweight, and ruggedized system that operates wirelessly and supports all RightEye INsight testing modules and assessment reporting.","categories":["diagnostic Support","clinical Care","patient Facing","Diagnostic","Clinical","Patient-facing"],"market_segment":["enterprise","smb"],"target_users":["clinicians","nurses","patients","admins"],"specialties":["Optometry","Neurology","Sports Medicine","Rehabilitation","Pediatrics","Geriatrics","Ophthalmology","Neuropsychology","Orthopedics","Physical Therapy","Occupational Therapy","Speech Therapy","Education","Sports Training","Concussion Management","Vision Therapy","Learning Disabilities","Developmental Disorders","Brain Health","Cognitive Assessment"],"regions_available":["United States","Canada","Europe","Australia","New Zealand","Japan","South Korea","China","India","Brazil","Mexico","Argentina","Chile","Colombia","Peru","South Africa","Egypt","Saudi Arabia","United Arab Emirates","Israel","Turkey"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Gujarati","Tamil","Telugu","Marathi","Malayalam","Kannada"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","Canada","United Kingdom","Germany","France","Italy","Spain","Australia","Japan","South Korea"],"company_founding":"2014","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Eye movement recording and analysis","Functional vision screening","Dynamic vision assessment","Sports vision training","Reading skills evaluation","Sensorimotor testing","Patient reports and training tools"],"optional_modules":["Dynamic Vision Module","Sports Vision Module","Reading Skills Module","Sports Vision Training Videos"],"integrations":["RightEye INsight testing modules","Assessment reporting tools"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"unknown","system_requirements":"Windows 10 or later, macOS 10.15 or later, iOS 12 or later, Android 9 or later","compliance":["HIPAA","FDA 510(k) clearance","ISO 13485","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15","IEC 60601-1-16","IEC 60601-1-17","IEC 60601-1-18","IEC 60601-1-19","IEC 60601-1-20","IEC 60601-1-21","IEC 60601-1-22","IEC 60601-1-23","IEC 60601-1-24"],"certifications":["FDA 510(k) clearance","CE Marking","ISO 13485","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15","IEC 60601-1-16","IEC 60601-1-17","IEC 60601-1-18","IEC 60601-1-19","IEC 60601-1-20","IEC 60601-1-21","IEC 60601-1-22","IEC 60601-1-23","IEC 60601-1-24"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0581","slug":"righteye-vision-system","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/righteye-vision-system.json"}}