FDA Radiology AI Devices

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

PROMO is a mobile X-ray system designed for use in radiology to capture diagnostic images. This device helps clinicians by enabling flexible and convenient imaging at the point of care, potentially integrating AI for image processing or analysis to support clinical decisions.

This product is a series of diagnostic ultrasound systems used to capture real-time images of the body's internal structures, helping clinicians diagnose and monitor various medical conditions. It supports multiple models designed for different imaging needs and clinical environments.

MammoScreen BD is an AI-powered software designed to assist radiologists by automatically analyzing mammography images. It helps detect and assess breast density, improving the accuracy and consistency of breast cancer screening and diagnosis.

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 ACUSON Sequoia and ACUSON Origin Diagnostic Ultrasound Systems by Siemens are advanced ultrasound imaging devices used by clinicians to visualize internal structures of the body in real-time. They help in diagnosing a variety of conditions by providing high-quality ultrasonic images, aiding patient care through non-invasive and versatile imaging.

Methinks CTA Stroke is an AI software tool designed to assist clinicians by automatically analyzing CT angiography images of the brain to detect signs of stroke. It helps prioritize urgent cases by providing triage and notification, enabling faster diagnosis and treatment for patients.

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.

PHAROS is a computed emission tomography system used in radiology to help clinicians obtain detailed three-dimensional images of the body. This technology assists in the diagnosis and monitoring of various medical conditions by providing high-quality images that aid in accurate assessment and treatment planning.

VEA Align; spineEOS by EOS imaging is an AI-based software designed to automatically process radiological images of the spine. It helps clinicians by aligning and analyzing spinal images, improving accuracy and efficiency in diagnosing and treatment planning for spinal conditions.