{"product_name":"Broncholab","company_name":"Fluidda","product_url":"https://www.fluidda.com/broncholab/","company_url":"https://www.fluidda.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0518","summary":"Broncholab is a diagnostic platform that utilizes Functional Respiratory Imaging (FRI) to provide detailed, regional lung function insights, aiding in the diagnosis and monitoring of respiratory diseases.","description":"Broncholab, developed by Fluidda, analyzes CT scan data using FRI technology to deliver quantitative parameters for pulmonary tissue, supporting physicians in diagnosing and monitoring respiratory conditions. It offers detailed 3D segmentation, volumetric analysis, and density evaluations, facilitating personalized treatment plans. The platform has received FDA clearance and CE certification, ensuring its clinical applicability in the U.S. and Europe. Broncholab is accessible via a secure online portal, maintaining patient privacy and data security.","categories":["diagnostic Support","clinical Care","imaging Software","medical Device Software","Diagnostic","Clinical","Pulmonology","Imaging","Software-as-a-medical-device"],"market_segment":["enterprise","healthcare"],"target_users":["pulmonologists","radiologists","physicians","healthcare providers"],"specialties":["Pulmonology","Radiology","Respiratory Medicine"],"regions_available":["United States","European Union","Iceland","Liechtenstein","Norway"],"languages_supported":["English","Dutch","French","German","Spanish","Italian","Portuguese","Swedish","Norwegian","Danish","Finnish","Icelandic","Greek","Polish","Czech","Hungarian","Romanian","Bulgarian","Croatian","Slovak"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Belgium","United States","Germany","United Kingdom","France","Netherlands","Italy","Spain","Sweden","Norway"],"company_founding":"2006","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["Functional Respiratory Imaging (FRI)","Quantitative HRCT analysis","Regional lung function visualization","Disease progression monitoring","Therapy optimization support"],"optional_modules":[],"integrations":["High-Resolution CT (HRCT) scanners"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 510(k) clearance"],"certifications":["FDA 510(k) clearance"],"security_features":["Data encryption at rest","Data encryption in transit","Role-Based Access Control (RBAC)","Audit logs"],"privacy_features":["Data anonymization","Data minimization"],"data_residency":"US and EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0518","slug":"broncholab","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/broncholab.json"}}