FDA Radiology AI Devices

Syngo.Via RT Image Suite is a software tool designed to help clinicians visualize, manipulate, and contour medical images from various imaging modalities such as CT, MRI, and PET. It supports 3D and 4D image visualization and assists with the segmentation of tumors and organs-at-risk to aid in radiation therapy planning and response assessment. The software incorporates AI techniques, including deep learning-based contouring, to improve the accuracy and efficiency of treatment preparation, thereby enhancing patient care in radiation therapy.

SIS Software Version 3.6.0 is an advanced medical imaging application designed to assist neurosurgeons, neurologists, and radiologists by processing MRI and CT scans to create detailed 3D models of brain structures, particularly the subthalamic nuclei. It uses machine learning to enhance images, aiding in the visualization and planning of stereotactic brain surgeries, thereby improving surgical accuracy and patient outcomes.

AI-Rad Companion (Cardiovascular) is an AI-powered software that analyzes previously acquired CT chest images to segment the heart and aorta, quantify coronary calcium, and measure aortic diameters. It assists clinicians by providing quantitative and qualitative cardiovascular assessments to support diagnosis and evaluation in emergency, specialty, and general practice care.

D2P is a software tool developed by 3D Systems that processes medical imaging data (DICOM) to create 3D segmentations and physical models. It assists clinicians in surgical planning by allowing the generation of accurate physical replicas of anatomical regions from imaging data, supporting diagnosis and treatment decisions in cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and musculoskeletal areas.

AI-Rad Companion (Pulmonary) is advanced software designed to analyze CT images of the lungs. It helps clinicians by segmenting lung regions, measuring lung volumes, identifying areas with abnormal tissue density, and detecting lung lesions including solid pulmonary nodules. This enables efficient and precise assessment of lung disease from existing CT scans, supporting better diagnosis and treatment decisions in emergency and specialty care.

The iNtuition-Structural Heart Module by TeraRecon is a software tool designed to help cardiologists and radiologists visualize and measure structures of the heart and vessels. It supports image analysis, quantification of calcium, and provides detailed 2D/3D/4D visualizations to plan and evaluate cardiovascular interventions and surgeries, aiding clinicians in improved patient care.

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.

RayStation is a software system designed to assist radiation therapy staff in planning and analyzing radiation treatments. It uses patient imaging data from CT, PET, and MRI scans to create detailed treatment plans that optimize radiation delivery while protecting healthy tissue. The system includes features like image fusion, contouring, dose computation, and machine learning to optimize and adapt treatment plans efficiently, helping clinicians deliver precise and effective cancer therapy.

SIS Software version 3.3.0 is a medical imaging application that assists clinicians, including surgeons and neurologists, by enhancing and visualizing brain MRI images, specifically the subthalamic nucleus (STN). It uses AI and image processing techniques to create 3D models and supports image fusion and co-registration between MRI and CT scans to guide stereotactic surgical procedures more accurately.

MRCP+ v1.0 is a standalone software device from Perspectum Diagnostics that assists trained operators in the quantitative, non-invasive assessment of the biliary system using MR imaging data. It automatically generates 3D models of the biliary tree, measures bile duct widths, detects regions of variation, and provides tools for segmentation and volumetric analysis. This helps radiologists and clinicians better visualize and evaluate hepatobiliary structures, potentially improving diagnosis and patient care in biliary system diseases.