{"product_name":"Rayvolve","company_name":"AZmed","product_url":"https://www.azmed.com/rayvolve","company_url":"https://www.azmed.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0194","summary":"Rayvolve is an AI-powered diagnostic tool developed by AZmed that assists radiologists in detecting fractures and thoracic pathologies in X-ray images, enhancing diagnostic accuracy and workflow efficiency.","description":"Rayvolve is an AI-driven diagnostic solution designed to identify fractures and thoracic pathologies in X-ray images for both pediatric and adult patients. It integrates seamlessly into existing radiology workflows, providing rapid analysis and annotation of images to support clinicians in accurate and timely diagnoses. The tool has received FDA 510(k) clearance and CE marking, demonstrating its compliance with regulatory standards. Clinical studies have shown that Rayvolve improves diagnostic accuracy and reduces interpretation time, thereby enhancing patient care and operational efficiency in medical imaging.","categories":["clinical Care","diagnostic Support","radiology","imaging Software","Clinical","Diagnostic","Radiology","Medical Imaging"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Radiologists","Emergency Physicians","Healthcare Professionals"],"specialties":["Musculoskeletal Radiology","Thoracic Radiology","Pediatric Radiology","Emergency Medicine"],"regions_available":["United States","European Union","France","United Kingdom","Germany","Italy","Spain","Netherlands","Belgium","Switzerland","Austria","Sweden","Denmark","Norway","Finland","Poland","Czech Republic","Slovakia","Hungary","Romania"],"languages_supported":["English","French","German","Italian","Spanish","Dutch","Swedish","Danish","Norwegian","Finnish","Polish","Czech","Slovak","Hungarian","Romanian"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["France","United States","United Kingdom","Germany","Italy","Spain","Netherlands","Belgium","Switzerland","Austria"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Fracture detection","Joint dislocation detection","Joint effusion assessment","Thoracic abnormality detection","Standardized orthopedic measurements","Pediatric bone age estimation","Automated report prefill","RIS integration","PACS integration","AI-driven triage","Clinical decision support","Workflow optimization","Clinical validation studies","FDA 510(k) clearance","CE marking","HIPAA compliance","GDPR compliance","Data encryption","Audit logs","Single Sign-On (SSO)"],"optional_modules":["AZtrauma","AZchest","AZmeasure","AZboneage"],"integrations":["PACS","RIS","EDL","Evolucare","SimonMed Imaging"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"yes","system_requirements":"Dedicated hardware, Cloud-based","compliance":["HIPAA","GDPR","SOC 2","ISO 27001","FDA 510(k)","CE marking"],"certifications":["FDA 510(k)","CE marking","ISO 27001","SOC 2 Type II"],"security_features":["Data encryption","Audit logs","Single Sign-On (SSO)","Role-Based Access Control (RBAC)","Two-Factor Authentication (2FA)"],"privacy_features":["Data anonymization","Data minimization","Consent management","Data residency options"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0194","slug":"rayvolve","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/rayvolve.json"}}