{"product_name":"Lung Density Analysis™- Functional","company_name":"Imbio","product_url":"https://www.imbio.com/products/lung-density-analysis-functional/","company_url":"https://www.imbio.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0629","summary":"Lung Density Analysis™- Functional (LDAf) is an automated imaging tool that maps lung regions affected by COPD, asthma, and other conditions, aiding in personalized care decisions and surgical planning.","description":"LDAf utilizes patented Parametric Response Mapping (PRM) technology to provide comprehensive imaging of normal lung tissue, air-trapping, and emphysema areas. It offers detailed quantitative reports and 3D visualizations to assist clinicians in diagnosing and planning treatments for lung diseases.","categories":["diagnostic Support","clinical Care","patient Facing","Diagnostic","Clinical","Patient-facing"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","pulmonologists"],"specialties":["Pulmonology","Radiology","Thoracic Surgery"],"regions_available":["United States","Canada","European Union","Australia","Japan","South Korea","Brazil","Mexico","India","China","South Africa","Russia","Argentina","Chile","Colombia","Peru","Venezuela","Egypt","Saudi Arabia","United Arab Emirates","Israel"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","Canada","Germany","United Kingdom","France","Italy","Spain","Australia","Japan","South Korea"],"company_founding":"2012","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["Automated image analysis for COPD components","Mapping of normal lung, air-trapping, and emphysema areas","Quantitative analysis and 3D visualization","Physician summary reports with visualizations and data","Automated inspiration-expiration processing"],"optional_modules":["LungMap™ report for smoking cessation counseling"],"integrations":["GE Health Cloud","PACS","RIS"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"Compatible with GE Health Cloud and local PACS/RIS systems","compliance":["FDA 510(k) Cleared","CE Mark Certified","Health Canada Approved"],"certifications":["FDA 510(k) Cleared","CE Mark Certified","Health Canada Approved"],"security_features":["Data encryption","Access controls","Audit logs"],"privacy_features":["Data anonymization","Compliance with healthcare data privacy regulations"],"data_residency":"Hosted in GE Health Cloud; local deployment options available","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0629","slug":"lung-density-analysistm-functional","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/lung-density-analysistm-functional.json"}}