{"product_name":"Coronary Artery Calcification Solution","company_name":"Aidoc","product_url":"https://www.aidoc.com/solutions/cardiology/coronary-artery-calcification-solution/","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":"SW0125","summary":"Aidoc's Coronary Artery Calcification Solution is an AI-driven tool that automates the detection and quantification of coronary artery calcification (CAC) in non-contrast, non-gated CT scans, aiding in cardiovascular risk assessment and patient management.","description":"Aidoc's Coronary Artery Calcification Solution utilizes artificial intelligence to analyze non-contrast, non-gated CT scans, identifying and quantifying coronary artery calcification (CAC). It provides a four-category risk assessment for coronary artery disease, integrating seamlessly into existing radiology workflows to prioritize cases and facilitate timely follow-up care. The solution is FDA-cleared and CE-marked, ensuring compliance with regulatory standards. It is available in the United States and European Union, with support for English language users. The pricing model is enterprise-based, with costs determined by the number of analyses conducted. The company was founded in 2016 and has offices in Israel, the United States, and the United Kingdom.","categories":["clinical Care","diagnostic Support","cardiology","radiology","Clinical","Diagnostic","Cardiology","Radiology"],"market_segment":["enterprise","hospital"],"target_users":["radiologists","cardiologists","thoracic imaging specialists","referring clinicians","radiology technologists","hospital administrators"],"specialties":["Cardiology","Radiology","Thoracic Imaging"],"regions_available":["United States","European Union"],"languages_supported":["English"],"pricing_model":"enterprise_quote","pricing_details":"No public pricing; vendor offers enterprise licensing and deployment packages — contact Aidoc for pricing and trial information.","license":"commercial, proprietary","company_offices":["Israel","United States","United Kingdom"],"company_founding":"2016","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","Linux","Windows"],"features":["Automated detection and quantification of coronary artery calcification (CAC) from non-gated, non-contrast CT scans","Total coronary calcium volume quantification","Per-vessel and per-region calcium segmentation","Agatston-equivalent scoring and categorical CAC risk classification","Volumetric measurement and numeric result export","Opportunistic screening of incidental CAC","Prioritization and worklist tagging for radiologist review","Structured result and measurement visualization","Automated report text and snippet generation","Integration into radiology workflow and notifications","Batch processing and enterprise-scale throughput","Performance and quality assurance metrics and analytics dashboard"],"optional_modules":["Care coordination and patient tracking","Advanced patient management and follow-up workflow","aiOS enterprise platform integration","Triage and notification modules"],"integrations":["PACS (DICOM viewers/PACS systems)","Radiology Information System (RIS)","EMR/EHR - Epic","EMR/EHR - Cerner","aiOS (Aidoc enterprise platform)","Hospital IT systems for alerts and notifications","Third-party workflow partners and integrators"],"data_standards":["DICOM","HL7 v2","FHIR","SNOMED CT","ICD-10"],"api_available":"yes","system_requirements":"Linux-based server for on-prem deployments; web browser client; cloud-hosted option (SaaS)","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 13485"],"certifications":["FDA 510(k) cleared","CE Marked (Class IIa, MDR)"],"security_features":["Data encryption in transit (TLS)","Data encryption at rest","Role-based access control (RBAC)","Single sign-on (SSO) / SAML","Audit logging"],"privacy_features":["BAA available for US customers","Data anonymization/de-identification for research","Data minimization options","GDPR data subject support"],"data_residency":"Multi-region cloud options (US and EU region hosting available); on-premises deployment option for local data residency","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0125","slug":"coronary-artery-calcification-solution","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/coronary-artery-calcification-solution.json"}}