uMI Panvivo
Shanghai United Imaging Healthcare Co., Ltd.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.
Intended Use
The uMI Panvivo is a PET/CT system designed to provide anatomical and functional images, assessing metabolic and physiologic functions in various body parts, for aiding detection, localization, evaluation, diagnosis, staging, monitoring, and follow-up of abnormalities, lesions, tumors, inflammation, infection, organ function disorders and diseases in clinical areas such as oncology, infection, inflammation, and neurology. It is also used for low dose CT lung cancer screening within approved protocols, and to aid radiotherapy treatment planning and interventional radiology procedures.
Technology
The system combines a 295 mm axial field of view PET and 160-slice CT system including LYSO detectors and a 700 mm bore size. It employs the HYPER Iterative reconstruction algorithm and AI-based extended field of view (AIEFOV) algorithm to reduce truncation artifacts and enhance CT value accuracy. The system includes image acquisition, reconstruction, display, post-processing, and dose management components.
Performance
Non-clinical image performance tests confirmed the device met design specifications and is substantially equivalent to predicate devices. Performance evaluations of the HYPER Iterative reconstruction and AI EFOV algorithms were conducted with sample clinical images reviewed by board-certified radiologists, showing sufficient image quality for diagnostic use. The device complies with relevant electrical safety, electromagnetic compatibility, software, biocompatibility, and risk management standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/3/2024
2 months - 2
FDA Approval
8/15/2024
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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