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An expert panel's reading served as the reference. The software's prompts reached 90.97% sensitivity (95% CI 87.60% to 94.35%) and 94.98% specificity (92.59% to 97.38%). Both lower bounds exceeded the target of 80%. The software's processing time was 46.78±2.98 seconds. On 8 May 2026, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks) and recommended approval. The software read stored images, so it guided no care. The report does not name the sites.","category":"aggregate result","unexpected":false,"purpose":"Shanghai United Imaging Intelligence built uAI MI Onco to give trained doctors triage prompts for focal FDG uptake in the chest on whole-body PET/CT images of adults.","system":"uAI MI Onco (胸部核医学图像辅助分诊软件)","model_version":"Release 1.0 (full version 1.00-2-24)","developer":"Shanghai United Imaging Intelligence Co., Ltd. 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