uMI Panvivo (uMI Panvivo M)
Shanghai United Imaging Healthcare Co., Ltd.The uMI Panvivo M is an advanced PET/CT scanner that combines functional and anatomical imaging with integrated AI algorithms. These AI features help improve image quality by reducing artifacts and noise, correcting motion, and enhancing diagnostic accuracy for a wide range of clinical applications throughout the body. This device supports clinicians in detecting, staging, and monitoring diseases, leading to better patient care.
Intended Use
The system is a PET/CT system designed for providing anatomical and functional images. It is intended for assessing metabolic (molecular) and physiologic functions in various parts of the body, including whole body, brain, head and neck, heart, lung, breast, gastrointestinal, urinary and genital organs, musculoskeletal systems, and others.
Technology
Combines 235 mm axial FOV PET and 80-slice CT; features LYSO detectors, deep learning-based iterative reconstruction (HYPER Iterative, DeepRecon.PET, uExcel DPR), deep learning-based metal artifact correction (Deep MAC), motion correction (OncoFocus, NeuroFocus), and AI-based artifact reduction (Ultra EFOV). Supports installation in hospitals or vehicles.
Performance
Extensive non-clinical and clinical performance testing was performed. Image quality, artifact and noise reduction, and AI algorithm effectiveness were verified using phantoms and human datasets. Board-certified radiologists reviewed clinical sample images. All AI components (Deep MAC, uExcel DPR, OncoFocus, Ultra EFOV, DeepRecon.PET) met pre-defined acceptance criteria, showing improvements in noise, artifact reduction, and diagnostic image quality compared to standard methods.
Predicate Devices
No predicate devices specified
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