What happened
Yukun (Beijing) Network Technology built LiverMRDoc Pro, deep learning software that segments the liver and flags suspected focal lesions of 5 mm or more on adult liver MRI. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The trial was the maker's own, a retrospective, fully crossed multi-reader study of 392 cases at five hospitals, among them Beijing Friendship Hospital. An expert consensus served as the reference. With the software, lesion-level sensitivity rose by 0.0969 (95% CI 0.0840 to 0.1099). Case-level specificity fell by 0.0082, within the non-inferiority margin of -0.1. Median reading time was 2.90 minutes with the software and 3.42 minutes without. On 18 July 2024, CMDE concluded that “该产品上市带来的受益大于风险” (putting the product on the market brings benefits that outweigh the risks). It recommended approval. The doctors read stored images, so the software guided no care.
Sources
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Regulatory document, by authors with no tie to the system.
FAS 集:灵敏度差值为 0.0969,95%置信区间为(0.0840,0.1099),区间下限大于目标值 0,优效性假设成立。
在目前认知水平上,该产品上市带来的受益大于风险,符合现行的技术审评要求,建议予以注册。
Details
AI system
- Reported configuration
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Release 2 (full version 2.0.0.001)
- Workflow
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The software segmented the liver, its segments, vessels and lesions with deep learning and named the liver segments. It flagged suspected focal lesions of 5 mm or more for the reading doctor.
Follow-up
- Conditions for replication
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Patients are adults having liver MRI. Trained doctors read the images and do not base a clinical decision on the software alone.
Entry details
- Sector
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Healthcare.
- Purpose
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Yukun (Beijing) Network Technology built LiverMRDoc Pro to help trained doctors detect focal liver lesions of 5 mm or more on adult liver MRI.
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Cite this record
Peter H. Vartanian. (2026). LiverMRDoc Pro helped doctors find more liver lesions on MRI (AIBD-1062). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1062.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)