FDA Radiology AI Devices

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.

BrainInsight is a software tool designed to analyze low-field MRI brain scans automatically. It uses machine learning to segment brain structures, measure volumes, and provide annotated images and reports to assist clinicians in evaluating brain anatomy quickly and efficiently.

CorInsights MRI is an automated software that processes brain MRI scans to identify and measure brain structures. It helps clinicians by providing detailed volumetric reports comparing patient brain volumes to normal reference data, aiding in research and clinical assessment of neurologic conditions in adults 45 to 95 years old.

PROView is a software tool designed to help clinicians review and analyze prostate MRI scans by automatically segmenting the prostate gland and assessing lesions using AI-based deep learning techniques. It supports the evaluation of prostate lesions according to PI-RADS guidelines, providing measurements, scoring, and reporting functionalities to assist in diagnosis and treatment planning for prostate conditions.

AI-Rad Companion Organs RT by Siemens is a post-processing AI software that automatically contours organs at risk on CT images to aid radiation therapy treatment planning. It uses deep learning algorithms to generate organ contours that can be reviewed and accepted by trained medical professionals, helping streamline radiotherapy preparation and ensure accurate targeting of treatment.

The Neuro.AI Algorithm by TeraRecon, Inc. is an AI-powered medical imaging software that analyzes brain perfusion images acquired via CT or MRI. It processes dynamic imaging data to generate detailed maps of brain tissue blood flow and vascular structures, helping trained medical professionals assess brain perfusion and vascular health efficiently. The software outputs detailed parametric maps and visualization aids to support clinical diagnosis without replacing physician judgment.

AutoContour is a software tool that helps radiation treatment planners automatically contour and review anatomical structures in medical images, primarily CT scans, to prepare for radiation therapy treatment planning. It uses cloud-based machine learning algorithms to produce initial contours, and provides a web interface for review and editing, enhancing efficiency and accuracy for clinicians.

Quantib Prostate is advanced image post-processing software designed to assist trained medical professionals in analyzing prostate MRI scans. It provides tools for automatic and semi-automatic segmentation of the prostate, visualization of multiparametric MRI images, PI-RADS scoring, and lesion analysis. By combining multiple MRI sequences into a single view and supporting volume computations, it helps clinicians in the detailed interpretation of prostate imaging, potentially improving diagnostic accuracy.

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.

Cleerly Labs v2.0 is a web-based software that assists trained medical professionals by analyzing coronary CT images to detect atherosclerosis and stenosis. It uses AI to segment and label coronary arteries, enhancing efficiency and accuracy in diagnosing coronary artery disease and supporting clinical decision making.