Coronary Artery Calcification

JSON twin: https://www.healthaidb.com/software/coronary-artery-calcification.json

Company Name

Imbio

Product URL

https://www.imbio.com/products/coronary-artery-calcification

Company URL

https://www.imbio.com

Categories

• diagnostic Support
• clinical Care
• cardiology
• Diagnostic
• Clinical
• Cardiovascular

Summary

Imbio's Coronary Artery Calcification (CAC) software utilizes deep learning to analyze chest CT scans, identifying and quantifying calcified plaques in coronary arteries, aiding in cardiovascular risk assessment.

Description

Imbio's Coronary Artery Calcification (CAC) software is an FDA-cleared, CE-marked, and TGA-approved medical imaging solution that employs deep learning algorithms to automatically analyze non-contrast chest CT scans. It detects and quantifies calcified plaques in coronary arteries, providing annotated images and detailed reports to assist clinicians in evaluating coronary artery disease risk. The software integrates seamlessly into standard DICOM workflows, enhancing diagnostic efficiency without requiring manual intervention. It is effective in analyzing low-dose CT scans, making it suitable for use in lung cancer screening programs. The CAC software is designed to identify both positive findings and false positive artifacts, delivering an overall CAC score to support clinical decision-making.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• TGA approval pending

Company Founding

2012

Company Offices

• United States

Compliance

• HIPAA
• GDPR
• SOC 2
• ISO 27001

Customers

Data Residency

US/EU regions

Data Standards

• DICOM

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automated coronary artery calcification (CAC) scoring
• Quantification of calcified plaques in coronary arteries
• Integration with standard DICOM workflow
• Generation of annotated images and detailed reports
• Support for non-contrast chest CT scans
• FDA 510(k) clearance
• CE Mark certification
• TGA approval pending

Id

SW0346

Integration Partners

Integrations

• PACS
• DICOM viewers

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• consent mgmt
• anonymization
• data minimization

Product Code

SW0346

Product Name

Coronary Artery Calcification

Ratings

Regions Available

• United States
• European Union
• Australia

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

Specialties

• Cardiology

Support Channels

System Requirements

VMware

Target Users

• radiologists
• cardiologists
• clinicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "Coronary Artery Calcification",
  "company_name": "Imbio",
  "product_url": "https://www.imbio.com/products/coronary-artery-calcification",
  "company_url": "https://www.imbio.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0346",
  "summary": "Imbio's Coronary Artery Calcification (CAC) software utilizes deep learning to analyze chest CT scans, identifying and quantifying calcified plaques in coronary arteries, aiding in cardiovascular risk assessment.",
  "description": "Imbio's Coronary Artery Calcification (CAC) software is an FDA-cleared, CE-marked, and TGA-approved medical imaging solution that employs deep learning algorithms to automatically analyze non-contrast chest CT scans. It detects and quantifies calcified plaques in coronary arteries, providing annotated images and detailed reports to assist clinicians in evaluating coronary artery disease risk. The software integrates seamlessly into standard DICOM workflows, enhancing diagnostic efficiency without requiring manual intervention. It is effective in analyzing low-dose CT scans, making it suitable for use in lung cancer screening programs. The CAC software is designed to identify both positive findings and false positive artifacts, delivering an overall CAC score to support clinical decision-making.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
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    "Diagnostic",
    "Clinical",
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  ],
  "market_segment": [
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    "smb"
  ],
  "target_users": [
    "radiologists",
    "cardiologists",
    "clinicians"
  ],
  "specialties": [
    "Cardiology"
  ],
  "regions_available": [
    "United States",
    "European Union",
    "Australia"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
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  "company_founding": "2012",
  "deployment_model": [
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    "hybrid"
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  "os_platforms": [
    "Web"
  ],
  "features": [
    "Automated coronary artery calcification (CAC) scoring",
    "Quantification of calcified plaques in coronary arteries",
    "Integration with standard DICOM workflow",
    "Generation of annotated images and detailed reports",
    "Support for non-contrast chest CT scans",
    "FDA 510(k) clearance",
    "CE Mark certification",
    "TGA approval pending"
  ],
  "optional_modules": [],
  "integrations": [
    "PACS",
    "DICOM viewers"
  ],
  "data_standards": [
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  "api_available": "unknown",
  "system_requirements": "VMware",
  "compliance": [
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    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
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    "CE Mark",
    "TGA approval pending"
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  "security_features": [
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    "RBAC",
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    "audit logs",
    "2FA"
  ],
  "privacy_features": [
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    "consent mgmt",
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    "data minimization"
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  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0346",
  "slug": "coronary-artery-calcification",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
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}