FDA Radiology AI Devices

The EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound imaging devices that help clinicians visualize and assess various body regions using pulsed Doppler technology. These systems support medical diagnosis by providing high-quality ultrasound images and measurements, facilitating patient care in many clinical settings.

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 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.

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.

The ViewMate Ultrasound System by Shenzhen Mindray is a pulsed Doppler ultrasound imaging system. It provides clinicians with ultrasound imaging capabilities to assist in diagnostic examinations, helping to visualize blood flow and other physiological data non-invasively.

AngioWaveNet is software designed to automatically process radiological images, helping clinicians analyze images more efficiently and accurately by leveraging artificial intelligence.

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.

The ViewMate™ Multi Ultrasound System is an ultrasound imaging device that helps clinicians by providing high-quality pulsed Doppler ultrasonic images. It supports the diagnosis and assessment of various medical conditions by visualizing blood flow and tissue structures in real time.

Tempus Pixel is a software product that uses AI to automate the processing of radiological images, helping clinicians analyze medical scans more efficiently and accurately.

Salix Coronary Plaque (V1.0.0) is an AI-powered software designed to automatically process and analyze radiological images, specifically helping clinicians assess coronary artery plaques to improve cardiac care.