FDA Radiology AI Devices

The Optima Coil System is a medical device used in neurovascular procedures to embolize, or block, blood vessels in the brain. This helps treat conditions such as brain aneurysms or vascular malformations by preventing blood flow to problematic areas, supporting clinicians in preventing strokes or hemorrhages.

The uMR 680 is a magnetic resonance imaging (MRI) system produced by Shanghai United Imaging Healthcare Co., Ltd. It helps clinicians visualize detailed internal body structures to diagnose and monitor various medical conditions, enhancing patient care through advanced imaging capabilities.

Brain WMH by Quantib BV is an automated software tool designed to analyze brain MRI images for white matter hyperintensities (WMH). It helps clinicians identify and quantify these lesions, improving diagnosis and monitoring of neurological conditions.

The ECHELON Synergy is an MRI system developed by Fujifilm Corporation that helps clinicians obtain detailed images of internal body structures using nuclear magnetic resonance. This enables doctors to diagnose and monitor various medical conditions with precision.

SIGNA™ Sprint is an MRI imaging system from GE Medical Systems that helps clinicians capture detailed images of the body using nuclear magnetic resonance. It supports diagnostic imaging to detect and evaluate a variety of medical conditions, aiding doctors in diagnosis and treatment planning.

AI-Rad Companion Prostate MR is a software tool designed to assist radiologists by processing prostate MR images using artificial intelligence, helping improve detection and diagnosis of prostate-related conditions.

MuscleView 2.0 is an MRI imaging system that aids clinicians in visualizing and analyzing muscle tissue. It helps radiologists and healthcare providers obtain detailed images of muscle anatomy for diagnosis and treatment planning.

GBrain MRI by Galileo CDS, Inc is an AI-powered software designed to process MRI images automatically, helping radiologists interpret brain scans more efficiently.

Vista OS, Vista AI Scan, and RTHawk are AI-based systems designed to work with MRI imaging. These systems help clinicians acquire and process MRI scans more efficiently, potentially improving imaging quality and reducing scan time to assist diagnosis and patient care.

The InVision™ 3T Recharge Operating Suite is a system designed for magnetic resonance imaging (MRI). It helps clinicians by providing high-quality images of the body’s internal structures, aiding in diagnosis and treatment planning. This advanced MRI system supports detailed and clear imaging, improving patient care in radiology.