Sonix Health

JSON twin: https://www.healthaidb.com/software/sonix-health.json

Company Name

Ontact Health

Product URL

https://ontacthealth.com/sonix-health

Company URL

https://ontacthealth.com

Categories

• clinical Care
• diagnostic Support
• imaging Software
• cardiology
• ai Clinical Documentation Integrity
• clinical Decision Support
• software Development
• medical Device
• regulatory Compliance
• Clinical
• Diagnostic
• Medical Imaging
• Artificial Intelligence
• Software
• Fda-cleared
• Echocardiography
• Ultrasound Imaging

Summary

Sonix Health is an AI-driven software developed by Ontact Health to enhance the analysis of adult echocardiography ultrasound images, improving cardiac function assessment efficiency and accuracy.

Description

Sonix Health utilizes artificial intelligence to automatically classify ultrasound views, segment anatomical structures, and perform semi-automated measurements on B-mode, M-mode, and Doppler ultrasound images. It generates comprehensive reports and allows manual verification and adjustment of AI results, facilitating efficient cardiac function quantification for clinicians. The software is installed on customer PC hardware and operates within a local DICOM-compliant network. It employs a two-step AI algorithm: a single identification model for view classification, followed by deep learning models for segmentation and measurement of ultrasound images. Performance testing demonstrated 98.22% average accuracy in view recognition and 93.98% correlation with expert manual measurements, validating its safety and effectiveness. Sonix Health is intended for use by or on the order of a licensed physician, accepting DICOM-compliant medical images from ultrasound devices and indicated for use in adult populations. It is FDA-cleared under 510(k) number K230209, with approval granted on October 20, 2023.

Api Available

yes

Certifications

• SOC 2 Type 2
• GDPR
• HIPAA

Company Founding

2022

Company Offices

• South Korea
• United States

Compliance

• HIPAA
• GDPR
• SOC 2 Type 2
• DPA

Customers

Data Residency

US

Data Standards

• HIPAA
• GDPR
• SOC 2 Type 2
• DPA

Deployment Model

• SaaS

Features

• Automated transcription
• Translation
• Subtitling
• AI-powered transcription
• Medical transcription
• Clinical dictation support
• Specialized medical vocabularies
• Fast turnaround for clinical dictations
• Secure file storage
• SSL & at-rest encryption
• Two-factor authentication
• Role-based access controls
• Granular permissions for user roles
• Session timeout policies
• Continuous security control monitoring
• Data residency options
• GDPR compliance
• HIPAA compliance
• SOC 2 Type 2 compliance
• DPA-ready

Id

SW0121

Integration Partners

Integrations

• AWS
• Drata
• Microsoft Azure
• DigitalOcean

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Medical transcription
• Clinical dictation support
• Specialized medical vocabularies
• Fast turnaround for clinical dictations
• Secure file storage
• SSL & at-rest encryption
• Two-factor authentication
• Role-based access controls
• Granular permissions for user roles
• Session timeout policies

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• GDPR compliance
• HIPAA compliance
• SOC 2 Type 2 compliance
• DPA-ready

Product Code

SW0121

Product Name

Sonix Health

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

• SSL & at-rest encryption
• Two-factor authentication
• Role-based access controls
• Granular permissions for user roles
• Session timeout policies
• Continuous security control monitoring
• Data residency options

Specialties

• Cardiology
• Radiology
• Medical Imaging
• Echocardiography
• Ultrasound Imaging

Support Channels

System Requirements

Target Users

• Clinicians
• Cardiologists
• Medical Imaging Specialists
• Radiologists
• Physicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Sonix Health",
  "company_name": "Ontact Health",
  "product_url": "https://ontacthealth.com/sonix-health",
  "company_url": "https://ontacthealth.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0121",
  "summary": "Sonix Health is an AI-driven software developed by Ontact Health to enhance the analysis of adult echocardiography ultrasound images, improving cardiac function assessment efficiency and accuracy.",
  "description": "Sonix Health utilizes artificial intelligence to automatically classify ultrasound views, segment anatomical structures, and perform semi-automated measurements on B-mode, M-mode, and Doppler ultrasound images. It generates comprehensive reports and allows manual verification and adjustment of AI results, facilitating efficient cardiac function quantification for clinicians. The software is installed on customer PC hardware and operates within a local DICOM-compliant network. It employs a two-step AI algorithm: a single identification model for view classification, followed by deep learning models for segmentation and measurement of ultrasound images. Performance testing demonstrated 98.22% average accuracy in view recognition and 93.98% correlation with expert manual measurements, validating its safety and effectiveness. Sonix Health is intended for use by or on the order of a licensed physician, accepting DICOM-compliant medical images from ultrasound devices and indicated for use in adult populations. It is FDA-cleared under 510(k) number K230209, with approval granted on October 20, 2023.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "imaging Software",
    "cardiology",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "software Development",
    "medical Device",
    "regulatory Compliance",
    "Clinical",
    "Diagnostic",
    "Medical Imaging",
    "Cardiology",
    "Artificial Intelligence",
    "Software",
    "Medical Device",
    "Fda-cleared",
    "Echocardiography",
    "Ultrasound Imaging"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Cardiologists",
    "Medical Imaging Specialists",
    "Radiologists",
    "Physicians"
  ],
  "specialties": [
    "Cardiology",
    "Radiology",
    "Medical Imaging",
    "Echocardiography",
    "Ultrasound Imaging"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "South Korea",
    "United States"
  ],
  "company_founding": "2022",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Automated transcription",
    "Translation",
    "Subtitling",
    "AI-powered transcription",
    "Medical transcription",
    "Clinical dictation support",
    "Specialized medical vocabularies",
    "Fast turnaround for clinical dictations",
    "Secure file storage",
    "SSL & at-rest encryption",
    "Two-factor authentication",
    "Role-based access controls",
    "Granular permissions for user roles",
    "Session timeout policies",
    "Continuous security control monitoring",
    "Data residency options",
    "GDPR compliance",
    "HIPAA compliance",
    "SOC 2 Type 2 compliance",
    "DPA-ready"
  ],
  "optional_modules": [
    "Medical transcription",
    "Clinical dictation support",
    "Specialized medical vocabularies",
    "Fast turnaround for clinical dictations",
    "Secure file storage",
    "SSL & at-rest encryption",
    "Two-factor authentication",
    "Role-based access controls",
    "Granular permissions for user roles",
    "Session timeout policies"
  ],
  "integrations": [
    "AWS",
    "Drata",
    "Microsoft Azure",
    "DigitalOcean"
  ],
  "data_standards": [
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    "GDPR",
    "SOC 2 Type 2",
    "DPA"
  ],
  "api_available": "yes",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "GDPR",
    "SOC 2 Type 2",
    "DPA"
  ],
  "certifications": [
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    "GDPR",
    "HIPAA"
  ],
  "security_features": [
    "SSL & at-rest encryption",
    "Two-factor authentication",
    "Role-based access controls",
    "Granular permissions for user roles",
    "Session timeout policies",
    "Continuous security control monitoring",
    "Data residency options"
  ],
  "privacy_features": [
    "GDPR compliance",
    "HIPAA compliance",
    "SOC 2 Type 2 compliance",
    "DPA-ready"
  ],
  "data_residency": "US",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0121",
  "slug": "sonix-health",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/sonix-health.json"
  }
}