{"product_name":"Koios DS Breast","company_name":"Koios Medical","product_url":"https://koiosmedical.com/koios-ds-breast","company_url":"https://koiosmedical.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0131","summary":"Koios DS Breast is an AI-powered ultrasound software that assists physicians in early and accurate breast cancer diagnosis by analyzing ultrasound images and providing risk assessments.","description":"Koios DS Breast utilizes artificial intelligence and machine learning to analyze ultrasound images, offering decision support for breast cancer detection. It integrates with existing PACS workstations and ultrasound systems, providing automated lesion classification and BI-RADS alignment. The software has been FDA-cleared and CE-marked, demonstrating improved diagnostic accuracy and reduced benign biopsies in clinical studies.","categories":["clinical Decision Support","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","healthcare Software Solutions","Clinical Decision Support","Diagnostic Imaging","Medical Imaging","Artificial Intelligence","Healthcare Software"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","technologists"],"specialties":["Radiology","Oncology","Medical Imaging"],"regions_available":["United States","Europe","Asia","South America","Africa"],"languages_supported":["English","Spanish","German","French","Italian","Portuguese","Chinese","Japanese","Korean","Arabic","Russian","Turkish","Hindi","Swahili","Thai","Vietnamese","Indonesian","Tagalog","Polish","Dutch"],"pricing_model":"subscription","pricing_details":"Pricing based on annual diagnostic exam volume; contact vendor for details.","license":"commercial","company_offices":["United States","Germany","Italy","Spain","Turkey","United Kingdom","Kenya","South Africa","Singapore","Taiwan"],"company_founding":"2007","deployment_model":["SaaS","on_prem"],"os_platforms":["Web","Windows"],"features":["AI decision support for breast ultrasound","Risk-of-malignancy scoring","Image-level analysis (per selected ROI)","Ensemble ML algorithms trained on proprietary image dataset","Reduces unnecessary biopsies and follow-up","BI-RADS / TI-RADS alignment","Reports/decision support at point-of-care or via image viewer"],"optional_modules":["Thyroid analysis (Koios DS Thyroid product)"],"integrations":["PACS workstations","Reporting systems / EMR note export","GE HealthCare (LOGIQ E10)","GE HealthCare (Invenia ABUS)","iCAD"],"data_standards":["DICOM","HL7","BI-RADS","TI-RADS"],"api_available":"yes","system_requirements":"Connects to PACS/image viewers; web browser access; customer activation/installation per vendor playbook","compliance":["FDA 510(k) clearance","CE Mark","HIPAA","GDPR"],"certifications":["FDA 510(k)","CE mark"],"security_features":["Encrypted connections (TLS)","Role-based access controls","Audit logging"],"privacy_features":["Customer portal consent management","Data transfer notifications (EU→US disclosures)"],"data_residency":"US-hosted with cloud hosting options; transfers from EU to US (per vendor privacy/informed consent)","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0131","slug":"koios-ds-breast","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/koios-ds-breast.json"}}