Kardia 12L ECG System

JSON twin: https://www.healthaidb.com/software/kardia-12l-ecg-system.json

Company Name

AliveCor

Product URL

https://alivecor.com/products/kardia12L

Company URL

https://alivecor.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

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.

Api Available

yes

Certifications

• FDA 510(k) clearance
• CMS reimbursement approval
• Category III CPT codes

Company Founding

2011

Company Offices

• United States

Compliance

• HIPAA
• ISO 27001
• SOC 2 Type 2
• HITRUST e1 Certification

Customers

Data Residency

US and EU regions

Data Standards

• HL7
• FHIR
• DICOM

Deployment Model

• SaaS
• on_prem
• hybrid

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

Id

SW0488

Integration Partners

Integrations

• EHR systems
• KardiaPro API
• KardiaCare service features
• KardiaStation app

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• KardiaCare service features
• KardiaPro web-based portal

Os Platforms

• Web
• iOS
• Android

Pricing Details

Contact AliveCor for pricing information.

Pricing Model

contact vendor

Privacy Features

• BAA available
• consent management
• anonymization
• data minimization

Product Code

SW0488

Product Name

Kardia 12L ECG System

Ratings

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

""

Security Features

• Encryption
• RBAC
• SSO/SAML
• audit logs
• 2FA
• DLP

Specialties

• Cardiology

Support Channels

System Requirements

Compatible with iOS and Android devices running the Kardia app

Target Users

• clinicians
• nurses
• admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "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": [
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  "target_users": [
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    "nurses",
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  ],
  "specialties": [
    "Cardiology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
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  "pricing_model": "contact vendor",
  "pricing_details": "Contact AliveCor for pricing information.",
  "license": "commercial",
  "company_offices": [
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  "company_founding": "2011",
  "deployment_model": [
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  "os_platforms": [
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    "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": [
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    "KardiaCare service features",
    "KardiaStation app"
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  "data_standards": [
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    "FHIR",
    "DICOM"
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  "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"
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  "certifications": [
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    "CMS reimbursement approval",
    "Category III CPT codes"
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  "security_features": [
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    "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",
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}