{"product_name":"VUNO Med-Chest X-ray","company_name":"VUNO","product_url":"https://www.vuno.co/chest","company_url":"https://www.vuno.co","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0128","summary":"VUNO Med®-Chest X-ray™ is an AI-powered diagnostic support system that analyzes chest X-ray images to assist in detecting major lung diseases, including lung cancer, tuberculosis, and pneumonia.","description":"VUNO Med®-Chest X-ray™ is an AI-based diagnostic support system that analyzes chest X-ray images to detect major lung diseases, including lung cancer, tuberculosis, and pneumonia. It has been trained on tens of thousands of chest PA X-ray images collected from Korea’s leading hospitals to ensure shorter reading time and greater reading accuracy. The system is integrated with PACS and offers a cloud-based service, providing optimized forms of services such as APIs for user reading system settings. It has received approval from the Ministry of Food and Drug Safety (MFDS) in Korea and CE certification, allowing commercialization in 27 EU member states and other regions recognizing the CE mark. VUNO has partnered with Samsung Electronics to incorporate this AI solution into Samsung's premium mobile and ceiling-type digital X-ray systems, enhancing diagnostic capabilities in various clinical settings.","categories":["diagnostic Support","clinical Care","radiology","Diagnostic","Clinical","Radiology"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","medical professionals"],"specialties":["Pulmonology","Radiology"],"regions_available":["South Korea","European Union","Middle East","Asia","South America","Africa"],"languages_supported":["Korean","English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["South Korea","United States","Germany","Japan","China","India","Brazil","United Kingdom","France","Italy"],"company_founding":"2014","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","Windows"],"features":["Automated detection of five major chest X-ray findings: nodule/mass, consolidation, interstitial opacity, pleural effusion, pneumothorax","Triage and study prioritization with flagging/notification of critical cases","Localization/heatmap overlays on images","Integration with PACS for reading workflow","API endpoints for integration with reading systems","DICOM ingestion and DICOM SR generation","Structured result reporting (visual + quantitative)","Batch processing and queuing of studies","User interface for radiologist review and confirmation","Workflow metrics and time-to-read improvement tools"],"optional_modules":["Triage-specific workflow module","PACS connector / Link Triage","Enterprise API/integration package"],"integrations":["PACS (vendor neutral)","RIS","EMR/EHR (via integration; commonly integrated with hospital EMRs)","Vieworks (VXvue) integration (vendor partnership)","Samsung mobile X-ray embedding / OEM integration"],"data_standards":["DICOM","HL7 v2","FHIR","SNOMED CT","ICD-10"],"api_available":"yes","system_requirements":"Cloud-based service with DICOM store support; on-prem server option for enterprise PACS integration (supports standard DICOM/WADO endpoints)","compliance":["HIPAA","GDPR","FDA 510(k)","CE (MDR/IVDR scope)"],"certifications":["FDA 510(k) clearance (for triage variant)","CE (MDR/IVDR scope)","MFDS (K-FDA) approval"],"security_features":["Encryption in transit and at rest","Role-based access control (RBAC)","SSO/SAML support","Audit logs and access logging","Secure network integration with PACS"],"privacy_features":["BAA available for US customers","De-identification / anonymization options for research","Data minimization and retention controls"],"data_residency":"US and EU hosting options; cloud and on-prem region selection available","customers":[],"user_reviews":[],"ratings":[],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2020","integration_partners":[],"id":"SW0128","slug":"vuno-med-chest-x-ray","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/vuno-med-chest-x-ray.json"}}