FDA Radiology AI Devices

HepaFatSmart (V2.0.0) is an automated AI-assisted software that analyzes magnetic resonance imaging (MRI) datasets to measure liver fat quantitatively. It calculates volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), and steatosis grading without user input, supporting clinical diagnosis and management of fatty liver disease and screening of liver transplant donors. This software helps clinicians by providing consistent, reproducible liver fat measurements from MRI scans, aiding patient care in liver-related conditions.

LiverMultiScan v5 is software that helps clinicians assess liver health by analyzing MRI scans to generate detailed images and quantitative maps of liver tissue properties such as fat content, iron concentration, and T1 relaxation times. It aids doctors in diagnosis by providing automated liver segmentation and measurements that enhance non-invasive liver assessment.

Hepatica v1 is a software tool used by clinicians to analyze MRI scans of the liver. It processes MRI data to create detailed 3D models of the liver by segments and provides quantitative measurements of liver tissue health such as iron-corrected T1 and fat fraction. This information supports the evaluation of liver volume and health, aiding clinical and surgical decision making for patients.

HepaFat-AI is an AI-powered software that automatically analyzes MRI images of the liver to measure liver fat content. It helps clinicians assess fatty liver disease, monitor liver fat in patients undergoing weight loss, and screen liver transplant donors by providing quantitative and reproducible fat fraction results quickly without manual input.

LiverMultiScan (LMSv4) is a standalone software device that assists clinicians by processing MR images of the liver to provide quantitative maps and measurements that help characterize liver tissue health. It automates segmentation and analysis of MRI data to produce reports for trained clinicians to interpret as part of liver disease diagnosis and assessment.

LiverMultiScan (LMSv3) is a software tool that helps clinicians analyze liver MRI scans. It produces detailed images and quantitative maps of liver tissue properties such as fat content, iron levels, and T1 relaxation times to assist in non-invasive liver evaluation. This software aids trained operators in generating reports that help medical professionals diagnose liver diseases more accurately and efficiently.