FDA Radiology AI Devices

The BONX805 is a mobile X-ray system designed for radiology applications. It helps clinicians by providing portable X-ray imaging capabilities, facilitating diagnostic imaging in various clinical settings where mobility is essential.

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.

The uWS-Angio is an image processing system used in radiology to assist clinicians by enhancing and analyzing medical images, improving diagnosis and patient care.

The Hypertension Notification Feature (HTNF) is a software-only mobile medical application by Apple that uses AI to analyze pulse sensor data collected by Apple Watch to notify users of possible hypertension. It helps adults over 22 years who are not diagnosed with hypertension to identify potential high blood pressure patterns, guiding them for further evaluation, but it is not a diagnostic or monitoring tool. It is designed for over-the-counter use, providing accessible cardiovascular health insights from wearable technology.

The Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-2) is a radiological image processing system designed to assist clinicians during minimally invasive prostate surgery by providing enhanced navigation through medical imaging, improving surgical precision and outcomes.

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.

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

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.

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.

Hybrid Viewer by Hermes Medical Solutions AB is a software system designed to support medical imaging in computed emission tomography, helping clinicians view and analyze tomographic images for diagnostic purposes.