uAI MI Onco flagged chest uptake on PET/CT scans in China's review

In the maker's retrospective trial that China's CMDE reviewed, uAI MI Onco flagged focal FDG uptake in the chest with 90.97% sensitivity and 94.98% specificity against an expert panel.

  • Not rated an organization

    The software read stored images in the maker's pre-market trial, and no patient's care depended on it.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

A target of 80% for the lower 95% confidence bounds of sensitivity and specificity, with an expert panel's reading as the reference. Measured.

Without the system
Target of 80% for the lower confidence bounds
With it
Sensitivity 90.97% (87.60%，94.35%) and specificity 94.98% (92.59%，97.38%)
The system’s part
Not isolated. The trial measured the software's own prompts against an expert panel's reading. It did not compare doctors' readings with and without the software. The trial was the maker's own. The report says that the product uses deep learning on PET/CT images.
Not yet checked
LimitsCosts and harmsLearns from dataLater outcome

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Benefit type
Improved Task Accuracy
System
uAI MI Onco (胸部核医学图像辅助分诊软件)
Made by
Shanghai United Imaging Intelligence Co., Ltd. (上海联影智能医疗科技有限公司)
Used by
Shanghai United Imaging Intelligence (retrospective registration trial with 596 cases at two sites)
Where
Two trial sites that the report does not name, for a registration in China
Stage
Tested in a laboratory
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events
Collections
Scrutiny and findings
Last revised
1 November 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：胸部核医学图像辅助分诊软件 (technical review report for the registration of chest nuclear medicine image triage-aid software), acceptance no. CQZ2402165, applicant 上海联影智能医疗科技有限公司. 8 May 2026. Section 三、临床评价概述 (clinical evaluation).

    FAS 集和 PPS 集软件提示的灵敏度为 90.97%， 95%置信区间为 （87.60%， 94.35%） ，特异度为 94.98%，95%置信区间为（92.59%，97.38%）
    经综合评价，在目前认知水平上，认为该产品上市带来的受益大于风险，综合剩余风险可接受。

Details

AI system

Reported configuration

Release 1.0 (full version 1.00-2-24)

Workflow

The software segmented anatomical structures on CT and analyzed the PET images with deep learning. It gave triage prompts for focal FDG uptake in the chest.

Follow-up

Conditions for replication

Patients are adults with whole-body 18F-FDG PET/CT images. Trained doctors use the prompts and do not base a clinical decision on the software alone.

Entry details

Sector

Healthcare.

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.

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model, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). uAI MI Onco flagged chest uptake on PET/CT scans in China's review (AIBD-1092). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1092.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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