{"product_name":"Visage Breast Density","company_name":"Visage Imaging","product_url":"https://visageimaging.com/products/visage-breast-density","company_url":"https://visageimaging.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0481","summary":"Visage Breast Density is an AI-powered tool integrated into the Visage 7 Enterprise Imaging Platform, designed to assess mammographic breast density, aiding in breast cancer risk evaluation and detection.","description":"Visage Breast Density utilizes artificial intelligence to analyze mammographic images, providing consistent and objective breast density assessments. Developed in collaboration with Yale New Haven Health, it received FDA clearance in January 2021. The tool operates seamlessly within the Visage 7 platform, offering rapid, server-side processing for efficient clinical workflows. It has been validated in multiple clinical settings, demonstrating high agreement with radiologists and enhancing diagnostic accuracy. The AI inference runs in the background, delivering immediate results upon image acquisition, and integrates smoothly into existing PACS systems without disrupting radiologists' workflows.","categories":["clinical Care","diagnostic Support","ai Clinical Documentation Integrity","clinical Decision Support","imaging Software","radiology","Clinical","Diagnostic","Artificial Intelligence","Imaging","Radiology"],"market_segment":["enterprise","healthcare institutions","academic medical centers"],"target_users":["radiologists","clinicians","medical imaging professionals","healthcare administrators"],"specialties":["Radiology","Mammography","Oncology","Breast Imaging"],"regions_available":["United States","Canada","European Union","Australia","New Zealand","Japan","South Korea","Singapore","Brazil","Mexico","South Africa","India","China","South East Asia","Middle East","Russia","Turkey","Israel","Saudi Arabia","United Arab Emirates","Egypt"],"languages_supported":["English","German","French","Spanish","Italian","Dutch","Portuguese","Russian","Chinese","Japanese","Korean","Arabic","Turkish","Hebrew","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","Australia","Germany","United Kingdom","France","Italy","Spain","Netherlands","Canada","Japan"],"company_founding":"2008","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Breast density assessment","FDA-cleared AI classifier","Integration with Visage 7 Enterprise Imaging Platform","Automated quadrant navigation","Dynamic adaptation of priors","Enhanced tissue cropping","Support for digital breast tomosynthesis (DBT)","Rapid display of current and prior DBT images","Auto-Prior Rules for prior image retrieval","In-Viewer Workflow enhancements","Support for multiple monitor resolutions in protocols","Visual display of missing images in protocols","Integration with Nuance PowerScribe 360 | Reporting","Mobile diagnostic image and results access via Visage Ease Pro","Integration with Epic EHR","Integration with Primordial workflow orchestration","Integration with Visage Ease Pro for mobile access"],"optional_modules":["Visage AI Accelerator","Visage 7 Open Archive","Visage 7 Workflow"],"integrations":["Epic EHR","Primordial workflow orchestration","Nuance PowerScribe 360 | Reporting","Visage Ease Pro for mobile access"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"yes","system_requirements":"Major OS/DB/hardware needs, or empty if SaaS-only","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE Mark","Health Canada","TGA Australia"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA","DLP"],"privacy_features":["BAA available","consent mgmt","anonymization","data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":["4.8/5 (G2)","4.5/5 (G2)"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2015","integration_partners":[],"id":"SW0481","slug":"visage-breast-density","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/visage-breast-density.json"}}