FDA Radiology AI Devices

The uCT 550 is a computed tomography (CT) X-ray system designed to produce detailed cross-sectional images of the whole body, including head, neck, cardiac, and vascular regions. It uses advanced AI-based deep learning algorithms to enhance image quality, reduce noise, and allow for dose reduction. This system helps clinicians with better diagnostic imaging across multiple body regions with improved accuracy and efficiency.

The uCT 780 is a computed tomography (CT) system designed to produce cross-sectional images of the body including head, neck, chest, cardiac and vascular regions. It offers advanced AI-driven image reconstruction to improve image quality and reduce radiation dose, supporting lung cancer screening and various diagnostic tasks. This helps clinicians obtain clearer images for diagnosis while lowering radiation exposure for patients.

The uMI Panvivo is a PET/CT medical imaging system designed to provide combined anatomical and functional images for clinicians. It uses PET to show distribution of radiopharmaceuticals and CT to provide detailed anatomical information. The system supports assessment of metabolic and physiologic functions across various parts of the body including oncology, neurology, and infection imaging. It can also assist in treatment planning for radiotherapy and interventional radiology, improving diagnostic accuracy and patient care.

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.