uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.The uMI Panorama is a PET/CT system that provides combined metabolic and anatomical imaging to assist healthcare professionals in detecting, diagnosing, staging, and managing various diseases including oncology, cardiology, and neurology conditions. It supports both PET and standalone CT imaging and can be used for low dose CT lung cancer screening, enhancing patient care with fused functional and anatomical images.
Intended Use
The uMI Panorama is a diagnostic imaging system combining PET and CT modalities to assist healthcare providers in assessing metabolic and physiological functions and anatomical structures for detection, localization, diagnosis, staging, restaging, treatment planning, and response evaluation of diseases in oncology, cardiology, and neurology. It allows standalone CT diagnostic imaging and supports low dose CT lung cancer screening for early detection of lung nodules.
Technology
The uMI Panorama GS consists of a PET gantry with 504 detector rings (axial FOV 148 cm, scintillator material LYSO), combined with a multi-slice CT gantry (uCT ATLAS Astound system with 40 mm detector). It includes a patient table, power supply cabinet, reconstruction console and software for image acquisition, reconstruction, display, and post-processing. The PET system is an extended Field of View scanner using detectors same as the predicate device but increased detector rings from 120 to 504. The CT subsystem is the same as a previously cleared standalone diagnostic CT device.
Performance
Non-clinical image performance testing confirmed the proposed device meets design specifications and is substantially equivalent to the predicate device. The device complies with multiple international standards for electrical safety, electromagnetic compatibility, radiation protection, software life cycle processes, biocompatibility, and quality system regulations, ensuring safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/31/2023
1 month - 2
FDA Approval
7/26/2023
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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