uMI Panorama
Shanghai United Imaging Healthcare Co.,Ltd.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.
Intended Use
The uMI Panorama is a diagnostic imaging system combining PET and CT to assist qualified healthcare professionals in detection, localization, diagnosis, staging, restaging, treatment planning, and treatment response evaluation for diseases and disorders including oncology, cardiology, and neurology. It also supports low dose CT lung cancer screening.
Technology
The uMI Panorama GS combines a 148 cm axial FOV PET system using LYSO scintillators with a multi-slice CT system (uCT ATLAS Astound). It includes multiple AI-based algorithms for image reconstruction, noise reduction (AIIR Deep IR, HYPER Iterative, uExcel DPR), respiratory motion correction, CT-less attenuation correction, extended field of view imaging, kinetic modeling, motion management, and quality control.
Performance
Extensive non-clinical and bench testing per FDA recognized standards were conducted including algorithm and image performance tests. Clinical image samples were reviewed by board-certified US radiologists confirming image quality sufficient for diagnostic use. Bench tests and clinical evaluations showed AI algorithms like AIEFOV improve CT attenuation correction and PET image SUV accuracy, with consistent image quality and diagnostic confidence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/3/2024
2 months - 2
FDA Approval
8/30/2024
Other devices from Shanghai United Imaging Healthcare Co.,Ltd.
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panvivo2024 • 510K
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