FDA Radiology AI Devices

The Self-Propelled CT Scan Base Kit, combined with the Alphenix system and its software, provides advanced computed tomography imaging capabilities. It helps clinicians capture detailed cross-sectional images of patients to assist in diagnosis and treatment planning.

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.

Ligence Heart is an AI-driven software designed to automatically process radiological images for cardiac assessment. It helps clinicians by providing automated analysis of heart images, potentially improving diagnostic efficiency and accuracy.

The EMBOTRAP III Revascularization Device is a specialized catheter used to remove blood clots from vessels in the brain, helping to restore blood flow in patients with ischemic stroke. It assists clinicians in performing minimally invasive procedures that can improve outcomes for stroke patients by clearing vessel blockages.

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 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.

The Digital X-Ray DentiMax Pro Imaging System is an advanced digital extraoral X-ray imaging device used primarily in dental radiology. It helps dentists capture high-quality images of the oral and maxillofacial region to assist in diagnosis and treatment planning.

The uWS-Angio Pro is an image processing system developed by Shanghai United Imaging Healthcare Co., Ltd. It is used in radiology to assist clinicians by processing medical images, potentially improving the visualization and analysis of angiographic studies.

SwiftSight-Brain is a software designed to assist clinicians by automatically processing radiological images of the brain. It helps improve diagnostic efficiency by analyzing brain imaging data to support radiologists in identifying abnormalities.

Rapid Aortic Measurements is an AI-powered software product designed to automatically process radiological images to assist clinicians in measuring aortic structures quickly and accurately.