FDA Radiology AI Devices

The uMR Jupiter is an MRI system developed by Shanghai United Imaging Healthcare Co., Ltd. It produces detailed images of the body's internal structures using nuclear magnetic resonance, aiding clinicians in diagnosis and treatment planning.

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 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 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.

uOmniscan is a software that enables real-time remote collaboration and control of medical imaging devices, especially MRI scanners. It helps healthcare professionals remotely manage scans, train technicians, and enhance communication across different locations, increasing workflow efficiency and access to expert guidance.

The uMR Omega is a 3.0 Tesla superconducting MRI system designed to capture detailed anatomical and functional images of the head, body, and extremities. It supports various advanced imaging sequences and features, including new RF coils and enhanced image processing algorithms like SparkCo for artifact correction and Inline ECV for quantitative mapping. This device helps clinicians diagnose by providing high-quality images and assisting workflows such as breast biopsy and cardiac function analysis.

The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis and uCT ATLAS with uWS-CT-Dual Energy Analysis are advanced CT imaging systems that produce cross-sectional whole-body images using X-rays. They incorporate AI-based technologies to enhance image reconstruction, reduce artifacts, and improve diagnostic quality, particularly for cardiac imaging and lung cancer screening. The systems support low dose CT for early lung nodule detection and use dual energy imaging for detailed tissue characterization.

Medical Image Post-processing Software (uOmnispace.CT) is sophisticated software designed to help radiologists and clinicians view, manipulate, evaluate, and analyze CT medical images. It includes multiple specialized processing applications for lungs, heart, brain, liver, bone structure, vascular structures, and more, helping clinicians quantify and characterize anatomical and functional information to support diagnosis and treatment planning.

uWS-Angio Basic is medical image management and processing software designed to handle X-ray angiographic, CT, and MRI images. It provides clinicians with tools for viewing, processing, calibration, and measurement of 2D and 3D vascular images, supporting improved diagnosis and treatment planning in angiography and related procedures.

The uAngio AVIVA CX is an advanced angiographic X-ray system designed to assist clinicians during diagnostic, interventional, and surgical procedures such as cardiac and neuro-angiography. It provides precise, intelligent image guidance with 2D and 3D imaging capabilities and software features such as camera-assisted recognition and voice control, helping to improve procedural accuracy and patient safety.