{"product_name":"IQ-UIP","company_name":"Imbio","product_url":"https://www.imbio.com/iq-uip","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":"SW0112","summary":"IQ-UIP is an AI-powered software developed by Imbio to analyze chest CT scans for detecting signs of usual interstitial pneumonia (UIP), aiding clinicians in diagnosing interstitial lung disease.","description":"IQ-UIP is a computer-aided software designed to analyze non-contrast chest CT scans to detect and notify specialists about radiological findings suggestive of usual interstitial pneumonia (UIP), a type of fibrotic lung disease. It works alongside standard radiological workflows to help clinicians by providing summarized findings via a worklist application, assisting in the evaluation of interstitial lung disease without altering original images or providing diagnostic conclusions itself. The device uses an artificial intelligence algorithm to analyze chest CT images and identify positive findings suggestive of UIP. It provides results on a separate worklist application running in parallel to the standard radiological interpretation workflow, without altering the original images. The model was developed using anonymized, multi-center retrospective chest CT data and validated via ground-truthing by expert radiologists. Software validation included integration, regression, algorithm validation, design verification, and standalone performance assessment. The device demonstrated an AUC ROC of 96.6%, sensitivity of 90.2%, and specificity of 91.5% on 804 patient images with a prevalence of 24% for UIP pattern. Ground truth was established by five experienced board-certified radiologists.","categories":["clinical Care","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","radiology","Clinical","Diagnostic Imaging","Artificial Intelligence","Radiology","Pulmonology"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Radiologists","Pulmonologists","Medical Imaging Specialists"],"specialties":["Pulmonology","Radiology","Cardiology","Oncology","Emergency Medicine","Internal Medicine","Geriatrics","Family Medicine","Critical Care","Pathology","Thoracic Surgery","Orthopedics","Rheumatology","Infectious Disease","Allergy And Immunology","Sleep Medicine","Sports Medicine","Palliative Care","Pediatrics","Obstetrics And Gynecology"],"regions_available":["United States","Canada","European Union","Australia","New Zealand","Japan","South Korea","China","India","Brazil","Mexico","South Africa","United Kingdom","Germany","France","Italy","Spain","Netherlands","Sweden","Norway","Denmark"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Swedish","Norwegian","Danish","Finnish","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Tamil"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","Australia","United Kingdom","Germany","France","Italy","Spain","Netherlands","Sweden","Norway"],"company_founding":"2014","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["AI-powered quality management system","Configurable industry-specific applications","Cloud or on-premises deployment","Continuous validation","Document search indexing","Electronic signatures","Email notifications","Language localization","Large file size support","Robust audit trail","AI-powered analytics","Enterprise reporting","Enterprise APIs & BI connectors","Validated out-of-the-box solutions","Industry-specific apps for Manufacturing and Life Sciences","ISO 9001, 14001, 45001, and 27001 certified"],"optional_modules":["Data IQ™ reporting","Search IQ™","Intellect AI™ Smart Analysis","App Modules"],"integrations":["OpenAI","Okta","Entra ID","AWS","Azure","GCP"],"data_standards":["FHIR","HL7 v2","DICOM","SNOMED","ICD-10"],"api_available":"yes","system_requirements":["AWS","Azure","GCP","Linux","Windows","macOS"],"compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001","ISO 9001","ISO 14001","ISO 45001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 9001","ISO 14001","ISO 45001","ISO 27001"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP"],"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":"SW0112","slug":"iq-uip","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/iq-uip.json"}}