ClariSIGMAM

JSON twin: https://www.healthaidb.com/software/clarisigmam.json

Company Name

ClariPi

Product URL

https://claripi.com

Company URL

https://claripi.com

Categories

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

Summary

ClariSIGMAM is an AI-powered software solution that accurately assesses breast density from standard digital mammograms, aiding in breast cancer risk evaluation.

Description

ClariSIGMAM is a breast density assessment solution developed by ClariPi Inc. It utilizes deep learning technology to analyze fat and glandular tissue composition in mammograms, providing precise and consistent density estimates. The software is fully automated, offering a smart workflow that simplifies compliance with breast density notification laws. It is compatible with multi-vendor full-field digital mammography (FFDM) scanners and integrates seamlessly with digital mammography and PACS systems. ClariSIGMAM has achieved a 97% accuracy rate in breast density estimation, as confirmed in published studies. It is FDA 510(k) cleared and CE certified, ensuring its safety and efficacy for clinical use. The software is intended to assist radiologists in assessing breast tissue composition, thereby aiding in breast cancer risk evaluation. ClariSIGMAM is available for purchase through ClariPi's distribution channels, including Calantic, Blackford, deepcOS, and Eureka Clinical AI. Pricing models include pay-per-use, subscription, and one-time license fees, based on the number of installations or analyses. ClariPi Inc., founded in 2015, is a South Korea-based company specializing in AI-driven medical imaging solutions. The company has offices in South Korea and the United States, with plans for global expansion. ClariSIGMAM is marketed and supported in multiple countries, including the United States, South Korea, and several European nations. The software supports multiple languages, including English, Korean, and Spanish, to accommodate a diverse user base. ClariSIGMAM is available through various pricing models, including pay-per-use, subscription, and one-time license fees, with pricing details available upon request. The software is licensed under commercial terms, with proprietary rights held by ClariPi Inc.

Api Available

unknown

Certifications

• FDA 510(k) cleared
• CE certified
• MDD Class I
• ISO/IEC 27001:2022 certified
• ISO/IEC 27018 certified
• SOC 2 Type 2 attested

Company Founding

2015

Company Offices

• South Korea
• United States

Compliance

• FDA 510(k) cleared
• CE certified
• MDD Class I
• ISO/IEC 27001:2022 certified
• ISO/IEC 27018 certified
• SOC 2 Type 2 attested

Customers

Data Residency

US/EU regions

Data Standards

• DICOM

Deployment Model

• on_prem
• cloud
• embedded
• SaaS

Features

• Automated breast density analysis from digital mammograms
• Quantification of breast and glandular areas
• Percentage density measurement
• DICOM-compliant structured reporting
• Integration with PACS systems
• Color overlay reports for AI-predicted tissue types
• Compatibility with multi-vendor FFDM scanners
• Simplified compliance with breast density notification laws

Id

SW0449

Integration Partners

Integrations

• PACS systems
• Digital mammography systems
• RIS
• CIS

Languages Supported

• English
• Korean
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Swedish
• Norwegian
• Danish
• Finnish
• Polish
• Russian
• Chinese
• Japanese
• Arabic
• Hindi
• Bengali

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Windows
• Linux

Pricing Details

Pricing models include pay-per-use, subscription, and one-time license fees, based on the number of installations or analyses. Contact ClariPi for detailed pricing information.

Pricing Model

subscription

Privacy Features

• Data residency options
• GDPR compliance
• Data subject access and deletion request automation
• Consent and preference management
• Vendor risk assessments
• Data mapping automation

Product Code

SW0449

Product Name

ClariSIGMAM

Ratings

Regions Available

• United States
• South Korea
• European Union
• Canada
• Australia
• Japan
• China
• India
• Brazil
• Mexico
• South Africa
• Russia
• United Kingdom
• France
• Germany
• Italy
• Spain
• Netherlands
• Belgium
• Sweden
• Norway

Related Urls

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

Release Year

Security Features

• Data encryption at rest and in transit
• Access control management
• Audit logs
• User authentication checks
• SAML2.0 compatible SSO
• Protected links with 256-bit AES encryption

Specialties

• Breast Imaging
• Oncology

Support Channels

System Requirements

GPU-accelerated computer

Target Users

• radiologists
• clinicians
• patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "ClariPi",
  "product_url": "https://claripi.com",
  "company_url": "https://claripi.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0449",
  "summary": "ClariSIGMAM is an AI-powered software solution that accurately assesses breast density from standard digital mammograms, aiding in breast cancer risk evaluation.",
  "description": "ClariSIGMAM is a breast density assessment solution developed by ClariPi Inc. It utilizes deep learning technology to analyze fat and glandular tissue composition in mammograms, providing precise and consistent density estimates. The software is fully automated, offering a smart workflow that simplifies compliance with breast density notification laws. It is compatible with multi-vendor full-field digital mammography (FFDM) scanners and integrates seamlessly with digital mammography and PACS systems. ClariSIGMAM has achieved a 97% accuracy rate in breast density estimation, as confirmed in published studies. It is FDA 510(k) cleared and CE certified, ensuring its safety and efficacy for clinical use. The software is intended to assist radiologists in assessing breast tissue composition, thereby aiding in breast cancer risk evaluation. ClariSIGMAM is available for purchase through ClariPi's distribution channels, including Calantic, Blackford, deepcOS, and Eureka Clinical AI. Pricing models include pay-per-use, subscription, and one-time license fees, based on the number of installations or analyses. ClariPi Inc., founded in 2015, is a South Korea-based company specializing in AI-driven medical imaging solutions. The company has offices in South Korea and the United States, with plans for global expansion. ClariSIGMAM is marketed and supported in multiple countries, including the United States, South Korea, and several European nations. The software supports multiple languages, including English, Korean, and Spanish, to accommodate a diverse user base. ClariSIGMAM is available through various pricing models, including pay-per-use, subscription, and one-time license fees, with pricing details available upon request. The software is licensed under commercial terms, with proprietary rights held by ClariPi Inc.",
  "categories": [
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    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "radiologists",
    "clinicians",
    "patients"
  ],
  "specialties": [
    "Breast Imaging",
    "Oncology"
  ],
  "regions_available": [
    "United States",
    "South Korea",
    "European Union",
    "Canada",
    "Australia",
    "Japan",
    "China",
    "India",
    "Brazil",
    "Mexico",
    "South Africa",
    "Russia",
    "United Kingdom",
    "France",
    "Germany",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Sweden",
    "Norway"
  ],
  "languages_supported": [
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    "Korean",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Swedish",
    "Norwegian",
    "Danish",
    "Finnish",
    "Polish",
    "Russian",
    "Chinese",
    "Japanese",
    "Arabic",
    "Hindi",
    "Bengali"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Pricing models include pay-per-use, subscription, and one-time license fees, based on the number of installations or analyses. Contact ClariPi for detailed pricing information.",
  "license": "commercial",
  "company_offices": [
    "South Korea",
    "United States"
  ],
  "company_founding": "2015",
  "deployment_model": [
    "on_prem",
    "cloud",
    "embedded",
    "SaaS"
  ],
  "os_platforms": [
    "Windows",
    "Linux"
  ],
  "features": [
    "Automated breast density analysis from digital mammograms",
    "Quantification of breast and glandular areas",
    "Percentage density measurement",
    "DICOM-compliant structured reporting",
    "Integration with PACS systems",
    "Color overlay reports for AI-predicted tissue types",
    "Compatibility with multi-vendor FFDM scanners",
    "Simplified compliance with breast density notification laws"
  ],
  "optional_modules": [],
  "integrations": [
    "PACS systems",
    "Digital mammography systems",
    "RIS",
    "CIS"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "GPU-accelerated computer",
  "compliance": [
    "FDA 510(k) cleared",
    "CE certified",
    "MDD Class I",
    "ISO/IEC 27001:2022 certified",
    "ISO/IEC 27018 certified",
    "SOC 2 Type 2 attested"
  ],
  "certifications": [
    "FDA 510(k) cleared",
    "CE certified",
    "MDD Class I",
    "ISO/IEC 27001:2022 certified",
    "ISO/IEC 27018 certified",
    "SOC 2 Type 2 attested"
  ],
  "security_features": [
    "Data encryption at rest and in transit",
    "Access control management",
    "Audit logs",
    "User authentication checks",
    "SAML2.0 compatible SSO",
    "Protected links with 256-bit AES encryption"
  ],
  "privacy_features": [
    "Data residency options",
    "GDPR compliance",
    "Data subject access and deletion request automation",
    "Consent and preference management",
    "Vendor risk assessments",
    "Data mapping automation"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0449",
  "slug": "clarisigmam",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
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    "self": "https://www.healthaidb.com/software/clarisigmam.json"
  }
}