{"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":["enterprise","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"}}