FDA Radiology AI Devices

The Vantage Orian 1.5T with AiCE Reconstruction Processing Unit for MR is a 1.5 Tesla MRI system from Canon that enhances image quality by using AI-powered noise reduction techniques. This advanced software algorithm uses deep learning to reduce thermal noise and improve signal clarity, especially in brain and knee imaging, helping clinicians obtain clearer and more diagnostically useful MRI images.

Ezra Plexo Software is a medical imaging application designed to help radiologists view, manipulate, and compare 2D and 3D MR images through a web browser. It supports oncological workflows by enabling visualization, evaluation, quantification, and documentation of lesions, facilitating better clinical assessment and decision-making.

AI-Rad Companion Brain MR is a software tool that helps clinicians analyze and evaluate brain MRI scans. It automatically segments and measures various brain structures, compares them with data from healthy individuals, and presents this information in an easy-to-understand report. This aids in diagnosis and treatment planning for patients with neurological conditions.

uWS-MR is a comprehensive medical imaging software that assists clinicians in viewing, manipulating, and analyzing MR images. It supports numerous advanced applications such as MR cardiac analysis, neuroimaging evaluation, spectroscopy, dynamic imaging, vessel analysis, and fusion of image series. It facilitates better interpretation and quantitative evaluation of various MR studies to aid diagnostic and clinical decision-making.

The uMR 780 is a 3.0 Tesla MRI system designed to generate high-quality cross-sectional and spectroscopic images of the head, body, and extremities. It assists clinicians in diagnosing various conditions by providing detailed anatomical and functional images, with the option to use contrast agents. The latest version includes software enhancements such as new pulse sequences and AI-assisted image reconstruction methods, improving image quality and analysis.

The SIGNA Premier by GE Healthcare is a whole-body magnetic resonance imaging (MRI) system designed to produce high-resolution diagnostic images of many body parts including the head, spine, joints, and heart. It incorporates a new AI-powered software feature called AIR Recon DL that improves image quality by enhancing signal-to-noise ratio and sharpness, while allowing for shorter scan times. This helps clinicians get clearer images faster, supporting better diagnosis and patient care.

Arterys MICA is a medical diagnostic software that processes and analyzes medical imaging data, primarily MR and CT scans. It includes AI modules that assist clinicians in quantifying heart function and detecting, evaluating, and tracking lesions for oncology purposes. The software supports trained healthcare professionals by providing quantitative data and visualization tools to aid diagnosis and treatment follow-up.

The Vantage Galan 3T with AiCE Reconstruction Processing Unit is a 3 Tesla MRI system from Canon that uses deep convolutional neural networks to reduce thermal noise and improve image quality in MRI scans, particularly for brain and knee regions. This advanced software and hardware combination helps clinicians obtain clearer MRI images, enhancing diagnosis without increasing scan time or contrast use.

MRCAT brain is a software add-on for Philips Ingenia MR systems that generates CT-like images from MR scans to assist in radiation therapy treatment planning for brain tumor patients. It helps clinicians by providing detailed tissue density maps necessary for accurate radiation dose calculations without the need for a separate CT scan.

QyScore Software is an automated medical image processing software that analyzes brain MRI scans to segment and measure brain structures and lesions. It generates an electronic report and overlays segmentations on images, helping clinicians quantify brain volumes compared to a healthy reference population. This assists in assessment and monitoring of brain health in patients aged 20 to 90 years.