FDA Radiology AI Devices

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.

Videa Dental AI is a medical imaging AI product designed to analyze radiology images related to dental applications. It helps clinicians by providing automated assessment of dental images, supporting decision-making and improving diagnostic efficiency.

The uDR Aurora CX is a stationary X-Ray system designed for radiology applications. It helps clinicians obtain high-quality X-Ray images which can be used for diagnostic purposes, potentially supporting AI tools in image analysis and patient care.

The ULTRASONIC PROBE UM-3R and UM-G20-29R are diagnostic ultrasonic transducers used to produce ultrasound images for medical evaluation. These probes help clinicians visualize internal organs and tissues noninvasively to aid in diagnosis and treatment planning.