uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

The uMI Panvivo and uMI Panvivo S systems are Class II PET/CT devices designed for comprehensive anatomical and functional imaging across oncology, neurology, and infection/inflammation. Utilizing Emission Computed Tomography technology, these systems facilitate detailed assessment of metabolic and physiologic functions, with non-clinical testing confirming their substantial equivalence to existing market devices based on performance, safety, and effectiveness.

The uMI Panvivo and uMI Panvivo S systems, developed by Shanghai United Imaging Healthcare Co., Ltd., have received a regulatory determination of substantial equivalence, classifying them as Class II Emission Computed Tomography (PET/CT) systems. These devices are intended to provide both anatomical and functional images, thereby allowing their manufacturer to market them in compliance with federal regulations and general controls. This determination signifies that the systems meet the necessary standards for safety and effectiveness comparable to devices already on the market. Designed for assessing metabolic and physiologic functions throughout the body, the uMI Panvivo systems offer broad clinical utility across oncology, infection and inflammation, and neurology for detecting, localizing, evaluating, diagnosing, staging, and monitoring various abnormalities and diseases. Additionally, their integrated CT component supports low-dose lung cancer screening and aids in radiotherapy treatment planning and interventional radiology procedures. The finding of substantial equivalence was substantiated by comprehensive non-clinical testing, including electrical safety, electromagnetic compatibility, software validation, and biocompatibility, confirming that even with a minor PET ring configuration change, the updated model maintains similar intended use, performance, safety, and effectiveness to its predecessor.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What are the specific performance metrics (e.g., spatial resolution, sensitivity) that established substantial equivalence for the uMI Panvivo systems?; Are there any head-to-head clinical trial data comparing the uMI Panvivo systems to existing gold standard PET/CT systems in specific clinical indications?; How does the 'slightly different PET ring configuration' of the updated model impact image quality or acquisition speed compared to its predecessor?; What specific software validation processes were undertaken to ensure the accuracy and reliability of diagnostic interpretations from the uMI Panvivo systems?; What are the long-term data collection plans for post-market surveillance regarding the uMI Panvivo's clinical effectiveness and safety across its diverse applications?