{"product_name":"EyeBOX","company_name":"Oculogica","product_url":"https://oculogica.com/eyeBOX","company_url":"https://oculogica.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0498","summary":"EyeBOX is a non-invasive, FDA-cleared device that objectively diagnoses concussions by analyzing eye movements, providing results in under four minutes without requiring a baseline test.","description":"EyeBOX is a lightweight, battery-operated device designed to aid in the diagnosis of concussions by measuring abnormalities in eye movements. It is FDA-cleared for use in both pediatric and adult patients, offering a non-invasive, baseline-free test that delivers results in less than four minutes. The device is suitable for various settings, including clinical environments and sports facilities, and has been validated through multiple peer-reviewed studies.","categories":["diagnostic Support","clinical Care","patient Facing","Diagnostic","Clinical","Patient-facing"],"market_segment":["enterprise","smb","consumer"],"target_users":["clinicians","nurses","patients","admins","payers"],"specialties":["Neurology","Sports Medicine","Pediatrics","Emergency Medicine"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States"],"company_founding":"2018","deployment_model":["on_prem","SaaS"],"os_platforms":["Windows","Linux"],"features":["FDA-cleared concussion diagnostic device","Non-invasive, baseline-free testing","Objective assessment using eye-tracking technology","Rapid test duration under 4 minutes","Immediate results with BOX score report","Portable and lightweight design","Suitable for patients aged 5 to 67","Clinically validated with multiple peer-reviewed studies","Battery-operated for flexible use","No literacy or language requirements for patients"],"optional_modules":[],"integrations":["Electronic Health Records (EHR) systems","Patient Management Systems","Clinical Decision Support Systems"],"data_standards":["HL7 v2","FHIR","DICOM"],"api_available":"unknown","system_requirements":"Windows 10 or later, Linux kernel 4.0 or later","compliance":["HIPAA","FDA 510(k)","ISO 13485","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-14","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)","CE Mark","ISO 13485","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-14","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","Role-Based Access Control (RBAC)","Audit Logs","Secure Data Transmission","Data Anonymization","User Authentication","Data Integrity Checks","Access Control Lists (ACLs)","Session Management","Data Masking"],"privacy_features":["Business Associate Agreement (BAA)","Data Minimization","Patient Consent Management","Data Anonymization","Data Encryption","Access Control","Audit Trails","Data Retention Policies","Data Deletion Procedures","Data Masking"],"data_residency":"US-based data centers","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0498","slug":"eyebox","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/eyebox.json"}}