{"product_name":"Coronary Artery Calcification","company_name":"Imbio","product_url":"https://www.imbio.com/products/coronary-artery-calcification","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":"SW0346","summary":"Imbio's Coronary Artery Calcification (CAC) software utilizes deep learning to analyze chest CT scans, identifying and quantifying calcified plaques in coronary arteries, aiding in cardiovascular risk assessment.","description":"Imbio's Coronary Artery Calcification (CAC) software is an FDA-cleared, CE-marked, and TGA-approved medical imaging solution that employs deep learning algorithms to automatically analyze non-contrast chest CT scans. It detects and quantifies calcified plaques in coronary arteries, providing annotated images and detailed reports to assist clinicians in evaluating coronary artery disease risk. The software integrates seamlessly into standard DICOM workflows, enhancing diagnostic efficiency without requiring manual intervention. It is effective in analyzing low-dose CT scans, making it suitable for use in lung cancer screening programs. The CAC software is designed to identify both positive findings and false positive artifacts, delivering an overall CAC score to support clinical decision-making.","categories":["diagnostic Support","clinical Care","cardiology","Diagnostic","Clinical","Cardiovascular"],"market_segment":["enterprise","smb"],"target_users":["radiologists","cardiologists","clinicians"],"specialties":["Cardiology"],"regions_available":["United States","European Union","Australia"],"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"],"features":["Automated coronary artery calcification (CAC) scoring","Quantification of calcified plaques in coronary arteries","Integration with standard DICOM workflow","Generation of annotated images and detailed reports","Support for non-contrast chest CT scans","FDA 510(k) clearance","CE Mark certification","TGA approval pending"],"optional_modules":[],"integrations":["PACS","DICOM viewers"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"VMware","compliance":["HIPAA","GDPR","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE Mark","TGA approval pending"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA"],"privacy_features":["BAA available","consent mgmt","anonymization","data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0346","slug":"coronary-artery-calcification","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/coronary-artery-calcification.json"}}