{"product_name":"Kardia 12L ECG System","company_name":"AliveCor","product_url":"https://alivecor.com/products/kardia12L","company_url":"https://alivecor.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0488","summary":"Kardia 12L ECG System is a portable, AI-powered device that enables rapid acquisition of 12-lead ECGs, facilitating quick detection of critical cardiac conditions.","description":"The Kardia 12L ECG System is a handheld, FDA-cleared device designed for healthcare professionals to efficiently capture 12-lead ECGs using a simplified leadset. Powered by KAI 12L AI technology, it detects 35 cardiac determinations, including heart attacks, and is suitable for various healthcare settings, including primary care and urgent care clinics. The device is battery-operated, lightweight, and user-friendly, making it accessible for healthcare providers in diverse environments.","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["enterprise","smb"],"target_users":["clinicians","nurses","admins"],"specialties":["Cardiology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"contact vendor","pricing_details":"Contact AliveCor for pricing information.","license":"commercial","company_offices":["United States"],"company_founding":"2011","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android"],"features":["AI-powered 12-lead ECG system","Single-cable design with 5 electrodes","Detects 35 cardiac determinations, including 14 arrhythmias and 21 morphologies","FDA-cleared for clinical use","Portable and lightweight (0.3 lbs)","Rapid ECG acquisition in minutes","Compatible with KardiaStation app for data management","Validated QT interval measurements","Supports integration with EHR systems via KardiaPro API","Battery-operated with extended operational time"],"optional_modules":["KardiaCare service features","KardiaPro web-based portal"],"integrations":["EHR systems","KardiaPro API","KardiaCare service features","KardiaStation app"],"data_standards":["HL7","FHIR","DICOM"],"api_available":"yes","system_requirements":"Compatible with iOS and Android devices running the Kardia app","compliance":["HIPAA","ISO 27001","SOC 2 Type 2","HITRUST e1 Certification"],"certifications":["FDA 510(k) clearance","CMS reimbursement approval","Category III CPT codes"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA","DLP"],"privacy_features":["BAA available","consent management","anonymization","data minimization"],"data_residency":"US and EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"\"\"","integration_partners":[],"id":"SW0488","slug":"kardia-12l-ecg-system","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/kardia-12l-ecg-system.json"}}