{"product_name":"Soteria.AI","company_name":"Omega Medical Imaging","product_url":"https://www.omegamedicalimaging.com/soteria-ai/","company_url":"https://www.omegamedicalimaging.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0440","summary":"Soteria.AI is an AI-powered imaging system by Omega Medical Imaging, designed to enhance cardiac care by reducing radiation exposure and improving image quality in interventional procedures.","description":"Soteria.AI integrates FluoroShield™, an AI-driven technology that minimizes X-ray exposure for patients and staff, with advanced imaging capabilities to deliver high-quality, precise diagnostic images. Its compact design and user-friendly features make it suitable for various cardiac catheterization labs, aiming to improve patient safety and procedural efficiency.","categories":["imaging Software","cardiology","radiology","interventional Procedures","medical Device","Clinical Imaging","Cardiology","Radiology","Interventional Procedures","Medical Devices"],"market_segment":["enterprise","smb"],"target_users":["cardiologists","radiologists","medical imaging technicians","hospital administrators"],"specialties":["Cardiology","Interventional Cardiology","Vascular Imaging","Diagnostic Imaging"],"regions_available":["United States","Canada","Europe","Asia","Australia"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Chinese","Japanese","Korean","Arabic"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States"],"company_founding":"1990","deployment_model":["on_prem"],"os_platforms":["Windows","Linux"],"features":["FluoroShield™: AI-powered radiation reduction","Nyquist.IQ imaging technology","Responsive CMOS detector","Enhanced vessel visualization","Built-in 58-inch HD monitor display","XY bridge for suspension monitoring","Customizable boom elevation","Rotatable C-ARM with telescoping SID","Programmable C-ARM positions","Rapid installation within weeks"],"optional_modules":["E-View.AI (Interventional Endoscopy)"],"integrations":["Epic","Cerner","PACS","Billing Systems"],"data_standards":["DICOM","HL7 v2","HL7 v3","FHIR","SNOMED CT","ICD-10","LOINC","CPT","ICD-9","NDC"],"api_available":"unknown","system_requirements":"Windows Server 2016 or later, Linux (Ubuntu 18.04 or later), Intel Xeon processor, 16 GB RAM, 1 TB HDD","compliance":["HIPAA","FDA 510(k)","ISO 13485","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15"],"certifications":["FDA 510(k)","CE Mark","ISO 13485","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15"],"security_features":["Encryption","RBAC","SSO/SAML","Audit Logs","2FA","DLP","Firewall","Intrusion Detection System","Data Masking","Access Control Lists"],"privacy_features":["BAA available","Consent Management","Anonymization","Data Minimization","Data Retention Policy","Data Access Controls","Data Encryption","Data Masking","Data Segregation","Data Integrity Checks"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0440","slug":"soteria-ai","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/soteria-ai.json"}}