FDA Radiology AI Devices

The uDR 780i is a digital medical X-ray system designed for diagnostic imaging of various anatomical sites, including the skull, spinal column, chest, abdomen, and extremities. It supports examinations for both adult and pediatric patients in multiple positions. This system generates high-quality radiographic images that can be reviewed, stored, and shared via DICOM network, aiding clinicians in accurate and efficient diagnosis.

The uDR 380i Pro from Shanghai United Imaging Healthcare Co.,Ltd. is a mobile digital radiography system that captures X-ray images of human anatomy for medical diagnosis. Designed for use on both adult and pediatric patients, it is especially useful for patients who cannot be moved to a traditional radiology room. The system includes flat panel detectors, a high-power generator, and a maneuverable design, enabling clinicians to obtain high-quality diagnostic images at the point of care.

The uMI Panorama is a combined PET/CT diagnostic imaging system designed to assist healthcare professionals in detecting and evaluating diseases like cancer, heart, and neurological disorders. It fuses PET metabolic functional imaging and CT anatomical imaging with advanced AI algorithms to improve image quality, reduce artifacts, and enhance diagnostic confidence. It supports PET/CT and single modality CT imaging, including low dose CT lung cancer screening, providing comprehensive information for patient management.

The uMI Panvivo is a combined PET/CT imaging system designed to provide high-quality functional and anatomical images to help clinicians detect, localize, evaluate, and monitor abnormalities such as tumors, lesions, infections, and other conditions across various body areas. It supports better patient experience with a large bore and advanced iterative reconstruction algorithms aided by deep learning, improving image quality and diagnostic accuracy. Additionally, it assists in radiotherapy planning and interventional radiology procedures.

The uPMR 790 by Shanghai United Imaging Healthcare Co., Ltd. is a combined PET and MRI system that simultaneously captures high-resolution metabolic and anatomical images of the body to assist clinicians in diagnosis. It includes advanced AI-based image reconstruction and processing techniques, like DeepRecon for denoising and ACS for accelerated image reconstruction, improving image quality and scan efficiency without radiation exposure from MRI. This helps healthcare providers better assess physiological and anatomical conditions in patients.

uOmnispace.CT is a comprehensive medical image management and processing software mainly for CT images, developed by Shanghai United Imaging Healthcare. It provides various AI-driven analysis tools including lung nodule detection, brain perfusion analysis, cardiovascular and liver evaluations, and more. This software supports clinical interpretation, visualization, and quantitative assessment, helping clinicians diagnose and plan treatments more efficiently across multiple organ systems.

uMR Jupiter is a 5 Tesla superconducting MRI system developed by Shanghai United Imaging Healthcare Co., Ltd. It generates detailed anatomical and functional images of the head, body, and extremities to assist clinical diagnosis. The device features advanced AI-accelerated image reconstruction technology, enhancing image quality and scan speed, supporting clinicians in making accurate and timely diagnoses.

uOmnispace.MR is advanced software developed by Shanghai United Imaging Healthcare Co., Ltd. that helps clinicians view, process, and analyze magnetic resonance (MR) images across various clinical applications such as brain, breast, cardiac, vascular, and neurological imaging. It supports interpretation and evaluation by providing tools for stitching, dynamic studies, spectroscopy, perfusion, vessel analysis, cardiac function analysis, and flow analysis, enabling improved diagnostic workflows and patient care.

The uMR 680 is a 1.5T superconducting magnetic resonance imaging device that produces detailed anatomical and functional images to assist physicians in diagnosis. It includes components such as magnets, RF coils, and software for imaging the head, body, and extremities, helping clinicians with diagnostic imaging using MRI technology.

The uMR Omega is a 3.0 Tesla superconducting MRI system designed for producing high-quality cross-sectional images and spectroscopic images of the head, body, and extremities. It helps clinicians diagnose by providing detailed anatomical and functional images that can be interpreted by trained physicians. This device is designed to meet industry imaging standards and includes advanced components such as RF coils and gradient amplifiers to ensure high image quality.