Shukun 数坤科技
40+ NMPA/CE/FDA-cleared AI imaging tools across heart, brain, chest
Overview
Shukun Technology (数坤科技), founded in Beijing in 2017, builds AI diagnostic-imaging software spanning 40-plus products across cardio, neuro, chest, abdominal and musculoskeletal scans. Deployed in nearly 3,000 China hospitals; holds NMPA Class III, EU MDR and FDA clearances.
What you can produce with Shukun 数坤科技
- "Digital Doctor" suite: 40+ AI imaging products (heart, brain, chest, abdomen, musculoskeletal)
- CoronaryDoc — world's first registered AI coronary-CTA stenosis analysis product
- 17 NMPA Class III + 14 Class II device certifications
- 10 EU MDR CE certifications, 1 PMDA (Japan), 2 FDA clearances
- Deployed in ~3,000 hospitals and 1,000+ health-check centers
- Simultaneous NMPA Class III + CE for both cardio/cerebrovascular and thoracic AI
ASEAN Perspective
Shukun 数坤科技 in Southeast Asia
ASEAN-region availability and pricing notes coming soon. Drop the editorial team a note via /contact/ if you can supply local context (Singapore/Malaysia/Indonesia/Thailand/Vietnam).
Breadth is the story here — Shukun's "Digital Doctor" line covers 40-plus imaging products across five organ systems, built on top of a coronary CTA tool that earned the world's first medical-device registration for AI coronary-stenosis analysis. As of March 2025 it holds 17 NMPA Class III certificates (more than any competitor in the category), 10 EU MDR CE marks, a Japanese PMDA approval and two FDA clearances, and it's the only company to hold simultaneous NMPA Class III and CE certification for both cardio/cerebrovascular and thoracic AI products.
The IPO path has been rocky: a 2021 Hong Kong listing application lapsed in 2022, and the company has since pivoted to a mainland STAR Market filing, reportedly targeting profitability around 2025 after years of losses funding the certification push. Like every clinical-AI vendor here, it sells to hospitals through partners, not self-serve — but the FDA and CE record makes it one of the more internationally credible names in Chinese medical-imaging AI.
What people say
Shukun is a hospital-procurement product, not a self-serve tool, so there's no meaningful body of independent consumer reviews — the record is regulatory filings, trade press and IPO-related financial disclosure instead.
On regulatory strength it's genuinely near the top of its category. As of March 2025 the company held 17 NMPA Class III certificates, 14 NMPA Class II, 10 EU MDR CE marks, one Japanese PMDA approval and two FDA clearances — more Class III registrations than any other player in Chinese medical-imaging AI, according to industry coverage. Its coronary CTA product, CoronaryDoc, was the first in the field globally to receive a medical-device registration certificate for AI-based coronary artery stenosis analysis, and the company says it's the only firm with simultaneous NMPA Class III and CE certification for both cardio/cerebrovascular and thoracic AI products at once. Deployment scale is large by any measure: coverage in nearly 3,000 hospitals and over 1,000 health-check centres, reaching 80% of China's top 100 hospitals and more than 30% of tertiary hospitals, with a cumulative claim of over 100 million patients served.
The financial picture is messier. Shukun first filed for a Hong Kong listing in September 2021; that application lapsed by March 2022 without pricing. It then pivoted toward a mainland STAR Market (科创板) filing, working with Huatai Securities as sponsor, with 2025 industry commentary suggesting the company was nearing profitability after roughly a decade of losses tied to certification and R&D spend. One Chinese finance outlet put cumulative cash burn near RMB1 billion against an 84% gross margin — figures that came from a single source and should be treated as directional rather than audited fact. A 2024 Hurun Global Unicorn Index entry valued the company around RMB9.2 billion.
There's no public pricing page, no free trial, and adoption depends entirely on hospital procurement cycles and (outside China) local device-approval processes — the FDA and EU MDR clearances make that path more plausible in more markets than most domestic-only competitors offer.
Summary of public user & expert reviews, compiled by RECATOOLS.
About this listing
This entry was compiled from publicly available data including Shukun 数坤科技's official website, press releases, documentation, and reputable third-party publications. RECATOOLS is not affiliated with Shukun 数坤科技 unless explicitly stated.
Third-party AI tools update their pricing, features, availability, and policies frequently. Information here may be outdated by the time you read this — we make reasonable efforts to keep listings current, but cannot guarantee absolute accuracy.
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