{"product_name":"CT Cardiomegaly","company_name":"Innolitics","product_url":"https://innolitics.com/ct-cardiomegaly/","company_url":"https://innolitics.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0251","summary":"CT Cardiomegaly is a command-line software developed by Innolitics that automatically calculates the cardiothoracic ratio from CT chest images to assist physicians in identifying cardiomegaly.","description":"CT Cardiomegaly is a command-line software application developed by Innolitics, LLC, designed to automatically calculate linear and area-based cardiothoracic ratios (CTR) from CT chest images. Utilizing non-adaptive machine learning algorithms, it measures the maximal transverse diameter of the heart and the maximal inner transverse diameter of the thoracic cavity. The software outputs PDF and JSON reports containing these measurements, aiding physicians in the identification of cardiomegaly. Intended users include physicians and licensed practitioners in healthcare institutions such as clinics, hospitals, and long-term care services. The system is suitable for adults and transitional adolescents (18 to 21 years old). Its results are not intended to be used on a stand-alone basis for clinical decision-making or to preclude clinical assessment of any disease. The software was FDA-cleared on February 28, 2024, under 510(k) number K232613. ([xrayinterpreter.com](https://xrayinterpreter.com/fda/K232613?utm_source=openai))","categories":["clinical Care","diagnostic Support","radiology","cardiology","Clinical","Diagnostic","Radiology","Cardiology"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","physicians","licensed practitioners"],"specialties":["Cardiology","Radiology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States"],"company_founding":"2012","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","Linux"],"features":["Automated calculation of linear and area-based cardiothoracic ratio (CTR) from CT chest images","Non-adaptive machine learning algorithm for heart and thoracic cavity segmentation","Command-line interface for integration into existing medical devices or standalone use","Generation of PDF and JSON reports containing CTR measurements","Intended for use by physicians and licensed practitioners in healthcare institutions"],"optional_modules":[],"integrations":["CT scanners","PACS systems"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"Linux-based systems with command-line interface","compliance":["HIPAA","FDA 510(k) clearance","ISO 9001:2015","SOC 2 Type I","ISO 27001","SOC 2 Type II","GDPR"],"certifications":["FDA 510(k) clearance","ISO 9001:2015","SOC 2 Type I","ISO 27001","SOC 2 Type II","GDPR"],"security_features":["Encryption","RBAC","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0251","slug":"ct-cardiomegaly","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/ct-cardiomegaly.json"}}