{"product_name":"HepaFatSmart","company_name":"Resonance Health","product_url":"https://www.resonancehealth.com/liver-cardiac-solutions/","company_url":"https://www.resonancehealth.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0342","summary":"HepaFatSmart is an AI-powered software developed by Resonance Health for non-invasive assessment of liver fat concentration using MRI scans.","description":"HepaFatSmart provides a comprehensive, automated evaluation of liver fat, including metrics such as Proton Density Fat Fraction (PDFF), Volumetric Liver Fat Fraction (VLFF), Steatosis Grade, and Liver Fat Distribution Map. It offers rapid, reproducible results without the need for contrast agents or additional equipment, making it suitable for both 1.5T and 3T MRI scanners. The software is FDA-cleared and CE-marked, ensuring its regulatory compliance for clinical use.","categories":["diagnostic Support","clinical Care","administrative Operations","Diagnostic","Clinical","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","medical researchers"],"specialties":["Hepatology","Radiology","Gastroenterology"],"regions_available":["United States","European Union","Australia"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Australia","United States","United Kingdom","European Union"],"company_founding":"2005","deployment_model":["cloud"],"os_platforms":["web"],"features":["MRI-based quantitative liver fat fraction (VLFF/PDFF) analysis","DICOM intake and secure transfer via FAST portal","Centralised core-lab image quality checks and analysis by physicists","Standardised HepaFat-Scan reporting (PDF report)","Rapid turnaround (typically within 2 business days)","Support for 1.5T and 3T MRI acquisitions","Vendor-independent analysis (works with multi-vendor MRI DICOMs)","Validated algorithm with published clinical evidence"],"optional_modules":[],"integrations":["CARPL.AI","FAST secure DICOM transfer portal","PACS/DICOM-compatible MRI scanners (vendor independent)","MRI vendors (1.5T and 3T systems)"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"DICOM-export-capable MRI scanner; internet access and web browser for FAST portal uploads","compliance":["FDA (510(k) clearance reference K201039 / K231459 for related HepaFat products)"],"certifications":["FDA 510(k) (see K201039 / related filings)"],"security_features":["Secure DICOM transmission via FAST portal","Centralised analysis with controlled access"],"privacy_features":["Secure transfer and reporting workflow"],"data_residency":"Resonance Health core lab (Australia - Burswood, Western Australia)","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0342","slug":"hepafatsmart","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/hepafatsmart.json"}}