PowerLook Density Assessment

JSON twin: https://www.healthaidb.com/software/powerlook-density-assessment.json

Company Name

iCAD

Product URL

https://www.icadmed.com/breast-health/ai-breast-density-assessment/

Company URL

https://www.icadmed.com

Categories

• diagnostic Support
• clinical Care
• administrative Operations
• Diagnostic
• Clinical
• Administrative

Summary

PowerLook Density Assessment is an AI-driven software by iCAD that automates breast density evaluation to enhance breast cancer detection accuracy.

Description

PowerLook Density Assessment utilizes artificial intelligence to analyze mammographic images, categorizing breast density according to the BI-RADS® 5th edition system. This standardization aids clinicians in identifying patients who may benefit from supplemental screenings, thereby improving early detection and patient outcomes. The software is compatible with digital breast tomosynthesis platforms from GE and Hologic systems, offering seamless integration into existing workflows. It has received FDA clearance, CE marking, and Health Canada licensing, ensuring its compliance with international standards. Additionally, the solution supports compliance with state and national reporting standards for dense breast notifications, facilitating proactive patient care. By removing subjectivity from breast density assessments, PowerLook Density Assessment provides consistent, accurate, and reliable results, thereby enhancing the overall quality of breast cancer screening processes.

Api Available

no

Certifications

• FDA 510(k)
• CE Mark
• Health Canada License

Company Founding

1986

Company Offices

• United States
• Germany
• United Kingdom
• France
• Italy
• Spain
• Netherlands
• Sweden
• Denmark
• Finland

Compliance

• FDA 510(k)
• CE Mark
• Health Canada License
• HIPAA
• GDPR

Customers

Data Residency

US and EU data centers

Data Standards

• DICOM
• HL7
• IHE
• BI-RADS® 5th edition

Deployment Model

• on_prem

Features

• Automated breast density assessment
• Integration with digital breast tomosynthesis (DBT) systems
• Standardized reporting aligned with BI-RADS® 5th edition
• Support for supplemental screening recommendations
• Personalized patient care plans
• Compliance with FDA-MQSA notification requirements

Id

SW0464

Integration Partners

Integrations

• GE mammography systems
• Hologic mammography systems

Languages Supported

• English
• French
• German
• Spanish
• Italian
• Dutch
• Portuguese
• Swedish
• Danish
• Finnish
• Norwegian
• Polish
• Czech
• Hungarian
• Romanian
• Bulgarian
• Greek
• Turkish
• Russian
• Ukrainian

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• ProFound Risk (short-term risk scoring)
• BAC Assessment (Breast Arterial Calcification)

Os Platforms

• Windows
• Linux

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Data anonymization/de-identification support

Product Code

SW0464

Product Name

PowerLook Density Assessment

Ratings

Regions Available

• United States
• European Union
• Canada

Related Urls

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

Release Year

Security Features

• Data encryption
• Role-based access control (RBAC)
• Audit logs
• Secure network communication

Specialties

• Radiology
• Oncology

Support Channels

System Requirements

Windows Server 2016 or later, Linux server with CentOS 7 or later, 16 GB RAM, 500 GB storage

Target Users

• clinicians
• radiologists
• admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "PowerLook Density Assessment",
  "company_name": "iCAD",
  "product_url": "https://www.icadmed.com/breast-health/ai-breast-density-assessment/",
  "company_url": "https://www.icadmed.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0464",
  "summary": "PowerLook Density Assessment is an AI-driven software by iCAD that automates breast density evaluation to enhance breast cancer detection accuracy.",
  "description": "PowerLook Density Assessment utilizes artificial intelligence to analyze mammographic images, categorizing breast density according to the BI-RADS® 5th edition system. This standardization aids clinicians in identifying patients who may benefit from supplemental screenings, thereby improving early detection and patient outcomes. The software is compatible with digital breast tomosynthesis platforms from GE and Hologic systems, offering seamless integration into existing workflows. It has received FDA clearance, CE marking, and Health Canada licensing, ensuring its compliance with international standards. Additionally, the solution supports compliance with state and national reporting standards for dense breast notifications, facilitating proactive patient care. By removing subjectivity from breast density assessments, PowerLook Density Assessment provides consistent, accurate, and reliable results, thereby enhancing the overall quality of breast cancer screening processes.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "administrative Operations",
    "Diagnostic",
    "Clinical",
    "Administrative"
  ],
  "market_segment": [
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    "smb"
  ],
  "target_users": [
    "clinicians",
    "radiologists",
    "admins"
  ],
  "specialties": [
    "Radiology",
    "Oncology"
  ],
  "regions_available": [
    "United States",
    "European Union",
    "Canada"
  ],
  "languages_supported": [
    "English",
    "French",
    "German",
    "Spanish",
    "Italian",
    "Dutch",
    "Portuguese",
    "Swedish",
    "Danish",
    "Finnish",
    "Norwegian",
    "Polish",
    "Czech",
    "Hungarian",
    "Romanian",
    "Bulgarian",
    "Greek",
    "Turkish",
    "Russian",
    "Ukrainian"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Germany",
    "United Kingdom",
    "France",
    "Italy",
    "Spain",
    "Netherlands",
    "Sweden",
    "Denmark",
    "Finland"
  ],
  "company_founding": "1986",
  "deployment_model": [
    "on_prem"
  ],
  "os_platforms": [
    "Windows",
    "Linux"
  ],
  "features": [
    "Automated breast density assessment",
    "Integration with digital breast tomosynthesis (DBT) systems",
    "Standardized reporting aligned with BI-RADS® 5th edition",
    "Support for supplemental screening recommendations",
    "Personalized patient care plans",
    "Compliance with FDA-MQSA notification requirements"
  ],
  "optional_modules": [
    "ProFound Risk (short-term risk scoring)",
    "BAC Assessment (Breast Arterial Calcification)"
  ],
  "integrations": [
    "GE mammography systems",
    "Hologic mammography systems"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "IHE",
    "BI-RADS® 5th edition"
  ],
  "api_available": "no",
  "system_requirements": "Windows Server 2016 or later, Linux server with CentOS 7 or later, 16 GB RAM, 500 GB storage",
  "compliance": [
    "FDA 510(k)",
    "CE Mark",
    "Health Canada License",
    "HIPAA",
    "GDPR"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "Health Canada License"
  ],
  "security_features": [
    "Data encryption",
    "Role-based access control (RBAC)",
    "Audit logs",
    "Secure network communication"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Data anonymization/de-identification support"
  ],
  "data_residency": "US and EU data centers",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0464",
  "slug": "powerlook-density-assessment",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/powerlook-density-assessment.json"
  }
}