uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.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.
Intended Use
The uMI Panorama is a diagnostic imaging system combining PET and CT to assist in detection, localization, diagnosis, staging, treatment planning and response evaluation of diseases, inflammation, infection and disorders in oncology, cardiology and neurology; allows single modality CT imaging and low dose CT lung cancer screening.
Technology
The system integrates PET system with scalable LYSO detectors (96 or 120 rings) with axial fields of view 280 or 350 mm and a 160-slice CT system (uCT ATLAS Astound). It employs AI-based iterative reconstruction (uExcel Iterative), neural network-based noise reduction (uExcel DPR), and respiratory motion correction (uExcel Focus) to enhance image quality and measurement accuracy.
Performance
Performance testing included dosimetry, image quality, non-clinical testing verifying design specifications and safety per multiple IEC and ISO standards. The device met all criteria and demonstrated similar safety and effectiveness compared to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/31/2022
4 months - 2
FDA Approval
3/10/2023
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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