{"product_name":"FractureDetect","company_name":"Imagen Technologies","product_url":"https://www.imagen-tech.com/solutions/fracturedetect","company_url":"https://www.imagen-tech.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0502","summary":"FractureDetect is an AI-powered software developed by Imagen Technologies to assist clinicians in detecting fractures during the review of musculoskeletal radiographs in adults.","description":"FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device designed to aid clinicians in identifying fractures in adult patients by analyzing radiographs of the musculoskeletal system. Utilizing supervised deep learning, it processes DICOM images from standard imaging devices or DICOM nodes, providing a toggleable annotation overlay on the original image within a PACS system to highlight fractures. The device operates securely with HIPAA compliance and is intended as an adjunct tool, not a replacement for a clinician’s review of the radiograph or clinical judgment. It was granted FDA 510(k) clearance on July 30, 2020, demonstrating high sensitivity (95.1%) and specificity (89.3%) in detecting fractures across various anatomical regions. ([fda.report](https://fda.report/PMN/K193417?utm_source=openai))","categories":["clinical Care","imaging Software","radiology","ai Clinical Documentation Integrity","clinical Decision Support","healthcare Software Solutions","Clinical","Diagnostic Imaging","Radiology","Artificial Intelligence","Medical Software"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Radiologists","Orthopedic Surgeons","Emergency Medicine Physicians","Primary Care Physicians"],"specialties":["Orthopedics","Emergency Medicine","Radiology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States"],"company_founding":"2016","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["AI-powered fracture detection","Real-time imaging analysis","Automated reporting","Integration with existing PACS systems","User-friendly interface","Scalable architecture","Cloud-based storage","HIPAA-compliant data handling","Multi-language support","Customizable alert thresholds"],"optional_modules":["Advanced analytics dashboard","Mobile application","Third-party EHR integration","Patient portal","Telemedicine integration"],"integrations":["PACS","EHR","RIS","HL7","DICOM","FHIR"],"data_standards":["HL7","DICOM","FHIR"],"api_available":"yes","system_requirements":"Windows Server 2016+, 8 GB RAM, 100 GB storage","compliance":["HIPAA","GDPR","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 13485"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA"],"privacy_features":["BAA available","consent mgmt","anonymization","data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0502","slug":"fracturedetect","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/fracturedetect.json"}}