FDA Radiology AI Devices

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.

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.

The uMI Panorama is a diagnostic imaging system combining PET and CT scans to provide both functional and anatomical information of the body. It helps healthcare professionals detect and evaluate diseases in oncology, cardiology, and neurology by offering fused metabolic and anatomical images. The device includes AI-based software updates to improve image reconstruction and analysis, enhancing diagnostic accuracy and patient management.

The uMI Panorama is a diagnostic imaging system that combines PET and CT imaging modalities to provide detailed metabolic and anatomical information. It assists clinicians in detecting, diagnosing, staging, and managing diseases, inflammation, infection, and disorders in multiple clinical fields. This system can also independently function as a CT scanner for lung cancer screening and delivers enhanced image reconstruction through AI algorithms, improving image quality and diagnostic accuracy.

The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is an advanced CT scanner designed to produce cross-sectional images of various body regions, including head, whole body, cardiac, and vascular areas. It integrates deep learning for image reconstruction to enhance image quality and reduce noise, and includes software for dual energy analysis to differentiate tissue types based on their chemical composition. This aids clinicians in lung cancer screening and detailed anatomical evaluation, supporting early diagnosis and treatment.

The uMR Omega with uWS-MR-MRS is a magnetic resonance imaging (MRI) system combined with advanced software solutions designed for viewing, manipulating, and analyzing MR images. It includes features such as AI-assisted image reconstruction and multiple post-processing tools that aid clinicians in evaluating anatomical and functional information. This helps radiologists and physicians diagnose more effectively by providing enhanced image quality and quantitative assessment capabilities.

The uCT ATLAS with uWS-CT-Dual Energy Analysis is a multi-slice CT scanner designed for producing cross-sectional images of the whole body and specific organs using advanced imaging technology. It features fast scanning with high spatial and temporal resolution, low radiation dose, and AI-based enhancements for image quality and patient positioning. Its dual energy analysis software helps differentiate tissue composition using CT images acquired at different energy levels, aiding diagnostic insights.

HYPER AiR is a software device that enhances PET images by using pre-trained neural networks integrated into the image reconstruction process. It helps radiologists and nuclear medicine physicians by reducing noise and improving image contrast in fluorodeoxyglucose (FDG) PET scans, thereby potentially improving diagnostic confidence.

Deep Recon is an AI-powered image reconstruction software designed for CT scanners. It uses deep learning technology to produce clearer CT images with less noise and better low contrast detectability, helping clinicians get accurate diagnostic images while potentially reducing the radiation dose for patients. It supports scans of the head, chest, abdomen, cardiac, and vascular regions, and is integrated into specific United Imaging CT scanners.