FDA Radiology AI Devices

GyriCalc (Version 1.0.0) is a radiological image processing system designed to assist clinicians by analyzing brain images. It helps in quantifying gyri patterns in the brain, which can aid in neurological assessments and diagnosis.

The Vantage Fortian/Orian 1.5T from Canon Medical Systems is an MRI system enhanced with the AiCE Reconstruction Processing Unit. It uses AI technology to improve image reconstruction, assisting clinicians in obtaining high-quality magnetic resonance images for diagnosis.

The Yushan X-Ray Flat Panel Detector is a digital imaging device designed to capture high-quality X-ray images for radiology. It helps clinicians obtain clear diagnostic images efficiently, supporting better patient diagnosis and care.

The V series Diagnostic Ultrasound System by Samsung Medison is an advanced ultrasound imaging device that helps clinicians visualize internal body structures using pulsed Doppler ultrasound. This assists in diagnosing and monitoring various medical conditions by providing real-time images and data of tissues and blood flow.

HeartFlow Analysis is a software tool that uses advanced imaging and computational models to simulate coronary vascular physiology. It helps clinicians assess blood flow in the coronary arteries non-invasively, aiding in diagnosis and treatment planning for cardiac patients.

The INNOVISION-P5 is a mobile X-Ray system designed to assist clinicians in acquiring X-Ray images at the point of care. This device enables flexible and mobile radiographic imaging, supporting patient diagnosis and treatment planning.

HESTIA is a full field digital mammographic x-ray system designed to assist clinicians in capturing detailed breast images for screening and diagnosis. This technology helps detect breast abnormalities, making it a valuable tool in breast cancer diagnosis and management.

The uMI Panvivo is a system for performing computed emission tomography, which helps clinicians visualize and analyze internal structures in the body for diagnostic purposes. It supports advanced imaging techniques to assist medical professionals in detecting and assessing diseases.

The e2Coil™ Imaging System is a specialized magnetic resonance coil designed to be used with Siemens MAGNETOM 3.0T MRI systems that have the Tim 4G connector. This coil improves the MRI imaging capabilities by enhancing signal reception, thereby helping clinicians obtain clearer and more detailed images for diagnosis and patient care.

The uMR Ultra is an MRI system developed by Shanghai United Imaging Healthcare. It uses nuclear magnetic resonance imaging technology to create detailed images of the body's internal structures, helping clinicians diagnose and monitor various medical conditions.