FDA Radiology AI Devices

EchoPAC Software is a tool developed by GE Medical Systems that processes ultrasound images to assist clinicians in analyzing echocardiography data. It helps in improving workflow efficiency and accuracy in cardiac ultrasound interpretation.

HyperVue™ Software is an imaging system that uses Optical Coherence Tomography (OCT) technology to produce detailed images of cardiovascular structures. It helps clinicians by providing high-resolution images that assist in diagnosing and treating cardiovascular diseases.

The uMR 680 is a nuclear magnetic resonance imaging system developed by Shanghai United Imaging Healthcare. It provides detailed internal body images useful for diagnosis and treatment planning, helping clinicians visualize patient anatomy non-invasively.

AV Viewer is a radiological image processing system designed to help clinicians view and analyze medical images more effectively. It assists healthcare providers by enhancing image visualization, supporting better diagnosis and patient care.

This product is a family of Philips MRI systems designed to produce detailed images of the body's internal structures. These MRI machines help doctors and clinicians by providing high-quality images that assist in diagnosing a variety of medical conditions across different body regions without using ionizing radiation.

The B-Scan device by ACCUTOME, INC. is an ultrasound imaging system that uses pulsed echo technology to capture images inside the body. It assists clinicians by providing detailed images useful for diagnosis and treatment planning in radiology.

This product consists of ultrasonic probes used in diagnostic imaging. These probes emit and receive ultrasound waves to create images of the body's internal structures, helping clinicians visualize and assess patients non-invasively.

The Sonosite LX Ultrasound System by FUJIFILM Sonosite is an advanced ultrasound imaging device used in medical settings. It assists clinicians by providing high-quality ultrasound and Doppler images, facilitating diagnosis and patient care in radiology.

Vivid Pioneer is an ultrasound imaging system using pulsed Doppler technology to help clinicians visualize and assess blood flow and cardiac function. It supports medical imaging and diagnosis, assisting healthcare professionals in evaluating patient health.

The Cios Alpha and Cios Flow devices by Siemens Medical Solutions USA are advanced interventional fluoroscopic X-ray systems. They provide real-time X-ray imaging to assist clinicians during interventional procedures, improving visualization and guidance for better patient outcomes.