{"product_name":"Malpositioned Endotracheal Tube Triage","company_name":"Aidoc","product_url":"https://www.aidoc.com/solutions/radiology/malpositioned-endotracheal-tube-ett/","company_url":"https://www.aidoc.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0001","summary":"Aidoc's Malpositioned Endotracheal Tube Triage is an AI-driven solution that analyzes chest X-rays to detect and prioritize vertically malpositioned endotracheal tubes, enhancing patient safety and workflow efficiency.","description":"The Malpositioned Endotracheal Tube Triage algorithm by Aidoc utilizes artificial intelligence to automatically analyze chest X-ray images, identifying cases where endotracheal tubes are positioned too close to the carina. This real-time triage system alerts clinicians to potential malpositions, enabling prompt corrective actions and reducing the risk of complications associated with tube misplacement. The solution integrates seamlessly into existing hospital IT systems, including PACS and RIS, and operates continuously in the background, ensuring timely detection and intervention. It has received FDA 510(k) clearance and CE Class IIa certification, underscoring its regulatory compliance and readiness for clinical deployment. The product is available through subscription-based pricing, with costs determined by the number of analyses performed, and is marketed in various countries, including the United States and Israel.","categories":["clinical Care","diagnostic Support","radiology","imaging Software","patient Safety","clinical Workflow Optimization","Clinical","Diagnostic","Radiology","Ai-powered Imaging","Patient Safety","Workflow Optimization"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Radiologists","Healthcare Administrators"],"specialties":["Chest Imaging","Anesthesiology","Emergency Medicine","Intensive Care","Pulmonology"],"regions_available":["United States","Israel","Europe","Asia","Australia","Canada","South America","Africa","Middle East","India"],"languages_supported":["English","Hebrew","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu"],"pricing_model":"subscription","pricing_details":"Subscription-based pricing, determined by the number of analyses performed; contact vendor for specific pricing information.","license":"commercial","company_offices":["United States","Israel","Germany","United Kingdom","France","India","China","Japan","Australia","Canada"],"company_founding":"2016","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["AI-driven triage and notification of malpositioned endotracheal tubes","Real-time image analysis","Automated flagging of critical findings","Integration with existing PACS systems","Vendor-neutral platform","HIPAA and GDPR compliance","FDA 510(k) clearance","ISO 13485:2016 certification","EU 2017/745 (MDR) compliance","ISO 14971 compliance","IEC 62304 compliance","Continuous AI review","Automated care coordination","Real-time image and data sharing","Cross-specialty workflow enhancement","Automated communication between desktop and mobile workflows","Vendor-neutral EHR and scheduling system integrations","Automated hub and spoke network creation","Standardized care pathways and transfers","Continuous, automatic AI review for expected and unexpected findings"],"optional_modules":["Patient Management System","Care Coordination Solution","Aortic Care Package","Pulmonary Embolism Care Coordination","Inferior Vena Cava Filter Detection","Pneumothorax Detection","Incidental Pulmonary Embolism Detection","Natural Language Processing Algorithm for Imaging Reports","Clinical Decision Support Tools","Advanced Reporting and Analytics"],"integrations":["PACS systems","EHR systems","Scheduling systems","AWS","Azure","HIPAA-compliant cloud infrastructure","FHIR","HL7","DICOM","SMART on FHIR","SNOMED CT","LOINC","ICD-10","ISO 13485:2016","ISO 14971","IEC 62304","FDA 510(k)","EU 2017/745 (MDR)"],"data_standards":["FHIR","HL7","DICOM","SMART on FHIR","SNOMED CT","LOINC","ICD-10","ISO 13485:2016","ISO 14971","IEC 62304"],"api_available":"unknown","system_requirements":"AWS, Azure, HIPAA-compliant cloud infrastructure","compliance":["HIPAA","GDPR","FDA 510(k)","ISO 13485:2016","EU 2017/745 (MDR)","ISO 14971","IEC 62304"],"certifications":["FDA 510(k)","ISO 13485:2016","EU 2017/745 (MDR)","ISO 14971","IEC 62304"],"security_features":["Encryption","Role-Based Access Control (RBAC)","Single Sign-On (SSO)","Audit Logs","Two-Factor Authentication (2FA)","Data Loss Prevention (DLP)"],"privacy_features":["Business Associate Agreement (BAA) available","Consent Management","Anonymization","Data Minimization"],"data_residency":"AWS, Azure, HIPAA-compliant cloud infrastructure","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"\"\"","integration_partners":[],"id":"SW0001","slug":"malpositioned-endotracheal-tube-triage","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/malpositioned-endotracheal-tube-triage.json"}}