{"product_name":"EFAI Chestsuite XR Malpositioned ETT Assessment System","company_name":"Cosmo Artificial Intelligence","product_url":"https://cosmoai.com","company_url":"https://cosmoai.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0095","summary":"EFAI Chestsuite XR Malpositioned ETT Assessment System is an AI-driven software that analyzes chest X-ray images to detect and alert healthcare professionals about endotracheal tube (ETT) malpositioning, facilitating timely medical intervention.","description":"EFAI Chestsuite XR Malpositioned ETT Assessment System is a computer-aided triage and notification software developed by Cosmo Artificial Intelligence - AI. Utilizing deep learning algorithms, it automatically analyzes chest X-ray images to identify potential vertical malpositioning of endotracheal tubes at the tracheal carina. Upon detection, the system actively sends alerts to PACS/RIS workstations, enabling healthcare professionals to promptly address ETT misplacement and reduce associated complications. The product has received medical device licenses from both the U.S. FDA (License No.: K242821) and Taiwan's TFDA (License No.: 008157).","categories":["clinical Care","diagnostic Support","radiology","ai Clinical Documentation Integrity","clinical Decision Support","Clinical","Diagnostic","Radiology","Artificial Intelligence"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Radiologists","Intensive Care Unit Physicians","Healthcare Administrators"],"specialties":["Intensive Care","Anesthesiology","Emergency Medicine","Pulmonology","Critical Care"],"regions_available":["United States","Taiwan"],"languages_supported":["English","Chinese"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","Taiwan"],"company_founding":"2020","deployment_model":["SaaS","on_prem"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Deep learning-based analysis of chest X-ray images","Detection of endotracheal tube (ETT) misplacement at the carina","Automated alerts to PACS/RIS workstations upon ETT misplacement detection","Enhanced speed in identifying ETT misplacement compared to standard clinical procedures"],"optional_modules":[],"integrations":["PACS","RIS"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"Major OS/DB/hardware needs, or empty if SaaS-only","compliance":["HIPAA","FDA 510(k)","ISO 27001"],"certifications":["FDA 510(k)","ISO 27001"],"security_features":["Encryption","RBAC","Audit logs","2FA"],"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":"SW0095","slug":"efai-chestsuite-xr-malpositioned-ett-assessment-system","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/efai-chestsuite-xr-malpositioned-ett-assessment-system.json"}}