{"product_name":"Rayvolve LN","company_name":"AZmed","product_url":"https://www.azmed.com","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":"SW0062","summary":"Rayvolve LN is an AI-powered software developed by AZmed to assist radiologists in detecting and highlighting suspected pulmonary nodules on frontal chest X-rays, enhancing diagnostic accuracy and workflow efficiency.","description":"Rayvolve LN is a computer-aided detection (CAD) software device designed to aid radiologists in identifying and marking regions related to suspected pulmonary nodules ranging from 6 to 30 mm in size on frontal chest radiographs of patients aged 18 years or older. It operates as a second reader, providing support without replacing the original chest images. The software utilizes deep learning techniques to detect and localize pulmonary nodules on chest X-rays, integrating with clinical DICOM nodes like PACS, and can run on-premise or in the cloud. It outputs fracture detection predictions as annotated images to assist doctors. Rayvolve LN has received FDA 510(k) clearance, confirming its safety and effectiveness for clinical use. Performance evaluations have demonstrated high sensitivity and specificity, with a significant improvement in diagnostic accuracy when used as an aid to radiologists. The software is CE-marked and FDA-cleared, ensuring compliance with international medical device regulations. It is used in over 2,500 healthcare centers across more than 55 countries, with over 9,000 doctors utilizing the solution daily. AZmed, founded in 2018, is a European MedTech startup committed to revolutionizing medical imaging through AI-powered solutions. The company has offices in multiple countries, including France, and has been recognized for its innovative approach to medical imaging. Rayvolve LN is part of AZmed's broader Rayvolve AI Suite, which includes modules for trauma detection, chest abnormalities, musculoskeletal measurements, and pediatric bone age assessment, all aimed at improving diagnostic precision and workflow efficiency in radiology.","categories":["clinical Care","diagnostic Support","radiology","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","software Development","healthcare It","medical Device","regulatory Compliance","Clinical","Diagnostic","Radiology","Medical Imaging","Artificial Intelligence","Software","Healthcare It","Medical Device","Fda-cleared","Ce-marked"],"market_segment":["Enterprise","SMB","Consumer"],"target_users":["Radiologists","Emergency Physicians","Healthcare Providers","Medical Imaging Professionals","Clinicians"],"specialties":["Radiology","Pulmonology","Emergency Medicine","Medical Imaging","Artificial Intelligence In Healthcare"],"regions_available":["United States","France","Germany","United Kingdom","Canada","Australia","Japan","South Korea","Brazil","India","China","South Africa","Mexico","Italy","Spain","Netherlands","Belgium","Sweden","Norway","Denmark"],"languages_supported":["English","French","German","Spanish","Italian","Dutch","Portuguese","Swedish","Norwegian","Danish","Finnish","Polish","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["France","United States","Germany","United Kingdom","Canada","Australia","Japan","South Korea","Brazil","India","China","South Africa","Mexico","Italy","Spain","Netherlands","Belgium","Sweden","Norway","Denmark"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Fracture detection","Joint dislocation detection","Assessment of joint effusions","Detection of thoracic abnormalities","Pulmonary nodule detection","Pneumothorax detection","Pleural effusion detection","Automatic linear and angular musculoskeletal measurements","Pediatric bone age calculation","Skeletal maturity assessment"],"optional_modules":["AZtrauma","AZchest","AZmeasure","AZboneage"],"integrations":["PACS","AI marketplace platforms","Third-party applications"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"Cloud-based, Locally on dedicated hardware","compliance":["HIPAA","GDPR","FDA 510(k)","CE Mark Class IIa","ISO 27001","SOC 2"],"certifications":["FDA 510(k)","CE Mark Class IIa","ISO 27001","SOC 2"],"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":"SW0062","slug":"rayvolve-ln","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/rayvolve-ln.json"}}