{"product_name":"AmCAD - UT","company_name":"AmCad BioMed Corporation","product_url":"https://amcadbio.com","company_url":"https://amcadbio.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0451","summary":"AmCAD-UT® is an AI-driven ultrasound computer-aided detection system designed to assist physicians in evaluating thyroid nodules for malignancy risk, enhancing diagnostic accuracy and efficiency.","description":"AmCAD-UT® utilizes patented image analysis technology to process 2D ultrasound images, quantifying and visualizing sonographic features of thyroid nodules. It analyzes characteristics such as hyperechoic foci, echogenicity, texture, margin, anechoic areas, height/width ratio, tumor shape, and tumor size, providing both visual and quantitative data to support diagnostic decisions. The system is compatible with all ultrasound systems and offers automated nodule recognition, adhering to global guidelines for effective patient management. It has received FDA 510(k) clearance, CE mark, TFDA, and CFDA certifications, ensuring its safety and efficacy. Additionally, AmCAD-UT® has been recognized with the Taiwan Excellence Award, highlighting its innovative contribution to medical imaging. ([amcadbiomed.com](https://www.amcadbiomed.com/product/ut?utm_source=openai))","categories":["diagnostic Support","clinical Care","administrative Operations","Diagnostic","Clinical","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","pathologists"],"specialties":["Radiology","Oncology","Endocrinology"],"regions_available":["United States","European Union","Taiwan","China"],"languages_supported":["English","Chinese","French"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Taiwan","United States","China","France"],"company_founding":"2008","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automated nodule recognition","Image calibration compatible with all ultrasound systems","Quantification and visualization of sonographic features","Recommendation based on global guidelines","Automated report generation"],"optional_modules":["Advanced analytics","Integration with AI marketplaces","Stand-alone web-based deployment"],"integrations":["PACS","AI marketplace platforms","Dedicated hardware systems"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"Dedicated hardware, cloud-based infrastructure","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001","EU MDR"],"certifications":["FDA 510(k)","CE mark","EU MDR"],"security_features":["Encryption","RBAC","SSO/SAML","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":"SW0451","slug":"amcad-ut","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/amcad-ut.json"}}