CoronaryDoc met its stenosis triage targets in China's review

In the maker's trial at three institutions that China's CMDE reviewed, CoronaryDoc's coronary stenosis triage met its sensitivity and specificity targets. No figures are given.

  • Not rated an organization

    The trial measured accuracy on stored images, it did not time the reading and the report gives no result from use after approval.

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

Manual reading as the gold standard, with preset targets for sensitivity and specificity. Measured.

The system’s part
Not isolated. The trial compared software-assisted reading with manual reading against preset targets. It did not time the reading, so the time saving that CMDE expects was not measured. The report says that three of the product's algorithms use deep learning.
Not yet checked
LimitsCosts and harmsLearns from dataLater outcome

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Benefit type
Reduced Task Time
System
CoronaryDoc (冠脉CT造影图像血管狭窄辅助分诊软件)
Made by
Yukun (Beijing) Network Technology Co., Ltd. (语坤（北京）网络科技有限公司)
Used by
Yukun (Beijing) Network Technology (retrospective blinded registration trial at three institutions)
Where
Three qualified medical institutions 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, Processing Information
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：冠脉CT造影图像血管狭窄辅助分诊软件 (technical review report for the registration of coronary CT angiography stenosis triage-aid software), acceptance no. CQZ2000143, applicant 语坤（北京）网络科技有限公司. 27 October 2020. Section 五、临床受益-风险评估 (clinical benefit-risk assessment).

    该产品在保证分诊提示准确率满足临床需求的基础上，可以大幅缩短阅片时间，减轻临床医师工作量。

Details

AI system

Reported configuration

Release 2.0 (full version 2.0.0.005)

Workflow

The software segmented and reconstructed the coronary arteries and myocardium on CTA images with deep learning. It gave triage prompts for coronary stenosis, and doctors could correct the segmentation and the vessel names. Manual reading served as the gold standard.

Follow-up

Conditions for replication

Images come from CT scanners with 64 or more rows and meet CTA examination standards. Patients do not have acute chest pain, diffuse coronary calcification or a history of percutaneous coronary intervention or bypass surgery. Trained doctors use the prompts and do not base a clinical decision on the software alone.

Entry details

Sector

Healthcare.

Purpose

Yukun (Beijing) Network Technology built CoronaryDoc to post-process coronary CT angiography and give trained doctors triage prompts for coronary stenosis.

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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). CoronaryDoc met its stenosis triage targets in China's review (AIBD-1079). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1079.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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