DenSeeMammo

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

Company Name

Statlife

Product URL

https://www.mammorisk.com/US

Company URL

https://www.mammorisk.com/US

Categories

• diagnostic Support
• clinical Care
• clinical Decision Support
• Diagnostic
• Clinical
• Decision Support

Summary

DenSeeMammo is a software solution developed by Statlife for standardized and automated breast density assessment, aiding radiologists in evaluating mammogram images according to BI-RADS guidelines.

Description

DenSeeMammo analyzes digitally processed 2D mammograms to provide a breast density category assessment that aligns with radiologists' visual evaluations. It compares mammography images to a database of images previously assessed by a consensus of Mammography Quality Standards Act (MQSA) certified radiologists. The software is compatible with images obtained from GE Senographe Essentials systems and is intended to assist radiologists in the assessment of breast density, providing adjunctive information to support clinical decision-making. DenSeeMammo is not an interpretive or diagnostic aid; the final assessment of breast density category is made by an MQSA qualified interpreting physician.

Api Available

yes

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 13485
• ISO 14971
• ISO 27001
• SOC 2 Type II
• HIPAA
• GDPR
• HITECH

Company Founding

2004

Company Offices

• United States
• France

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• FDA 510(k)
• CE/MDR
• ONC
• ISO 13485
• ISO 14971

Customers

Data Residency

US/EU regions

Data Standards

• DICOM
• HL7 v2
• HL7 v3
• FHIR
• ICD-10
• SNOMED CT
• LOINC
• CPT
• ICD-9
• NDC

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automated mammography analysis
• Risk assessment algorithms
• Clinical decision support
• Patient data management
• Image processing and enhancement
• Reporting and analytics
• Integration with PACS systems
• Real-time notifications
• User-friendly interface
• Data visualization tools

Id

SW0587

Integration Partners

Integrations

• PACS systems
• Electronic Health Records (EHR)
• Hospital Information Systems (HIS)
• Laboratory Information Systems (LIS)
• Radiology Information Systems (RIS)
• Patient portals
• Mobile health applications
• Cloud storage services
• Telemedicine platforms
• Clinical trial management systems

Languages Supported

• English
• French

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Advanced image segmentation
• 3D imaging support
• Telemedicine integration
• Patient portal
• Mobile app support
• Cloud storage integration
• AI-driven predictive analytics
• Clinical trial management
• Regulatory compliance reporting
• Data anonymization tools

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact Statlife for pricing information.

Pricing Model

contact vendor

Privacy Features

• Business Associate Agreement (BAA) available
• Data anonymization and pseudonymization
• Consent management
• Data minimization
• Data retention policies
• User data access controls
• Regular privacy audits
• Compliance with privacy laws
• Data subject rights management
• Third-party data sharing controls

Product Code

SW0587

Product Name

DenSeeMammo

Ratings

Regions Available

• United States
• France

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
• Role-based access control (RBAC)
• Single Sign-On (SSO) via OAuth2 and SAML
• Audit logs and activity tracking
• Two-factor authentication (2FA)
• Data Loss Prevention (DLP)
• Regular security assessments
• Compliance with security standards
• Automated security updates
• Intrusion detection systems

Specialties

• Radiology
• Gynecology

Support Channels

System Requirements

Windows Server 2016 or later, 16 GB RAM, 500 GB HDD, 1 Gbps network

Target Users

• radiologists
• gynecologists
• healthcare professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "DenSeeMammo",
  "company_name": "Statlife",
  "product_url": "https://www.mammorisk.com/US",
  "company_url": "https://www.mammorisk.com/US",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0587",
  "summary": "DenSeeMammo is a software solution developed by Statlife for standardized and automated breast density assessment, aiding radiologists in evaluating mammogram images according to BI-RADS guidelines.",
  "description": "DenSeeMammo analyzes digitally processed 2D mammograms to provide a breast density category assessment that aligns with radiologists' visual evaluations. It compares mammography images to a database of images previously assessed by a consensus of Mammography Quality Standards Act (MQSA) certified radiologists. The software is compatible with images obtained from GE Senographe Essentials systems and is intended to assist radiologists in the assessment of breast density, providing adjunctive information to support clinical decision-making. DenSeeMammo is not an interpretive or diagnostic aid; the final assessment of breast density category is made by an MQSA qualified interpreting physician.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "clinical Decision Support",
    "Diagnostic",
    "Clinical",
    "Decision Support"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "radiologists",
    "gynecologists",
    "healthcare professionals"
  ],
  "specialties": [
    "Radiology",
    "Gynecology"
  ],
  "regions_available": [
    "United States",
    "France"
  ],
  "languages_supported": [
    "English",
    "French"
  ],
  "pricing_model": "contact vendor",
  "pricing_details": "Contact Statlife for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "France"
  ],
  "company_founding": "2004",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Automated mammography analysis",
    "Risk assessment algorithms",
    "Clinical decision support",
    "Patient data management",
    "Image processing and enhancement",
    "Reporting and analytics",
    "Integration with PACS systems",
    "Real-time notifications",
    "User-friendly interface",
    "Data visualization tools"
  ],
  "optional_modules": [
    "Advanced image segmentation",
    "3D imaging support",
    "Telemedicine integration",
    "Patient portal",
    "Mobile app support",
    "Cloud storage integration",
    "AI-driven predictive analytics",
    "Clinical trial management",
    "Regulatory compliance reporting",
    "Data anonymization tools"
  ],
  "integrations": [
    "PACS systems",
    "Electronic Health Records (EHR)",
    "Hospital Information Systems (HIS)",
    "Laboratory Information Systems (LIS)",
    "Radiology Information Systems (RIS)",
    "Patient portals",
    "Mobile health applications",
    "Cloud storage services",
    "Telemedicine platforms",
    "Clinical trial management systems"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2",
    "HL7 v3",
    "FHIR",
    "ICD-10",
    "SNOMED CT",
    "LOINC",
    "CPT",
    "ICD-9",
    "NDC"
  ],
  "api_available": "yes",
  "system_requirements": "Windows Server 2016 or later, 16 GB RAM, 500 GB HDD, 1 Gbps network",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 13485",
    "ISO 14971"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 13485",
    "ISO 14971",
    "ISO 27001",
    "SOC 2 Type II",
    "HIPAA",
    "GDPR",
    "HITECH"
  ],
  "security_features": [
    "Data encryption at rest and in transit",
    "Role-based access control (RBAC)",
    "Single Sign-On (SSO) via OAuth2 and SAML",
    "Audit logs and activity tracking",
    "Two-factor authentication (2FA)",
    "Data Loss Prevention (DLP)",
    "Regular security assessments",
    "Compliance with security standards",
    "Automated security updates",
    "Intrusion detection systems"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Data anonymization and pseudonymization",
    "Consent management",
    "Data minimization",
    "Data retention policies",
    "User data access controls",
    "Regular privacy audits",
    "Compliance with privacy laws",
    "Data subject rights management",
    "Third-party data sharing controls"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0587",
  "slug": "denseemammo",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/denseemammo.json"
  }
}