FDA Radiology AI Devices

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.

TINGSN FINDERS 2 is a color Doppler ultrasound system that helps clinicians visualize and assess blood flow and heart function using pulsed Doppler ultrasound technology. It assists in cardiovascular diagnosis by providing detailed images and flow information in real time.

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.

The Tomey Cornea/Anterior Segment OCT (CASIA2) is a medical imaging device that uses optical coherence tomography technology to capture detailed images of the cornea and anterior segment of the eye. It helps clinicians assess eye health and diagnose ocular conditions more accurately by providing high-resolution images of the eye structures.

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.

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 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.

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.