{"product_name":"VinDr-Mammo","company_name":"VinBigdata","product_url":"https://vinbigdata.com/xu-ly-anh-y-te/vindr-ai-ho-tro-chan-doan-som-nhieu-benh-ly-nguy-hiem-cua-nguoi-viet.html","company_url":"https://vinbigdata.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0211","summary":"VinDr-Mammo is an AI-powered software developed by VinBigdata to assist radiologists in prioritizing mammogram exams by identifying potentially suspicious findings, thereby enhancing workflow efficiency and expediting patient care.","description":"VinDr-Mammo is a software-as-a-medical-device (SaMD) that analyzes 2D full-field digital mammograms using machine learning algorithms to detect exam-level suspicious findings. It integrates with Picture Archiving and Communication Systems (PACS) to alert radiologists, facilitating prioritized review of critical cases. The software operates as a passive notification tool, ensuring it does not replace the physician's final diagnosis. It was approved by the FDA on May 23, 2024, under the 510(k) number K233108, and is intended for use with validated full-field digital mammography systems. Performance validation demonstrated high sensitivity (~90%), specificity (~91%), and an area under the curve (AUC) of approximately 0.96, consistent across various breast densities, age groups, scanner models, and lesion types. The average processing time per mammogram is 2.8 minutes, aligning with clinical workflow requirements. Notably, VinDr-Mammo is substantially equivalent to its predicate device, CogNet QmTRIAGE (K220080).","categories":["diagnostic Support","clinical Care","radiology","ai Clinical Documentation Integrity","imaging Software","Diagnostic","Clinical","Radiology","Ai-powered","Medical Imaging"],"market_segment":["enterprise","consumer"],"target_users":["radiologists","clinicians","medical imaging professionals"],"specialties":["Radiology","Oncology","Breast Imaging"],"regions_available":["United States","Vietnam"],"languages_supported":["English","Vietnamese"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Vietnam","United States"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automated diagnostics","AI-based lesion localization","Real-time analysis","Multi-point consultation support","Simultaneous diagnosis of multiple scans","Flexible scalability"],"optional_modules":["VinDr CAD","VinDr PACS","VinDr-SpineXR","VinDr-BrainCT","VinDr-BrainMRI"],"integrations":["PACS systems","RIS systems","Cloud storage solutions"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"N/A","compliance":["HIPAA","GDPR","FDA 510(k)"],"certifications":["FDA 510(k)"],"security_features":["Encryption","RBAC","Audit logs","2FA"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0211","slug":"vindr-mammo","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/vindr-mammo.json"}}