Shukun 数坤科技
Beijing imaging AI with China's most Class III approvals, by its own count
Overview
Shukun Technology (数坤科技), set up in Beijing in 2017, builds AI medical-imaging software for the heart, brain, chest, abdomen, thyroid and breast, and musculoskeletal system, plus a multimodal medical model. It reports 18 NMPA Class III certificates, holds EU MDR CE marks and Japanese PMDA approvals, and has three FDA 510(k) clearances, one via its Singapore-based Careverse brand.
Pricing
Pricing shown for reference only. These figures reflect RECATOOLS research as of 14 Oct 2026 and may be out of date or incomplete. This is not financial or purchasing advice — always confirm the current price on the provider’s official website before making any decision.
What you can produce with Shukun 数坤科技
- AI-assisted coronary CTA reading with stenosis and plaque analysis, plus CT-FFR
- Head-and-neck CTA, CT perfusion, ischaemic stroke and intracranial haemorrhage AI
- Lung-nodule, rib-fracture and other chest CT AI
- Liver MR, bone-density and breast-ultrasound AI
- The 数坤坤 multimodal medical model for in-hospital deployment
- Regional and hospital AI imaging platforms for primary care and screening
Shukun's case rests on approvals and breadth: 18 Chinese Class III certificates by its count, MDR CE marks across cardiac, stroke and other tools, PMDA approvals in Japan and three FDA 510(k) clearances, including CoronaryDoc through its Singapore-registered Careverse brand. Coronary CTA, where it started, remains the flagship.
It is a hospital procurement, sold by quote through trials and distributors, and its finances are opaque since a 2021 Hong Kong listing attempt lapsed. ASEAN buyers should confirm local registration before planning a deployment.
What we found
Shukun Technology (数坤科技) is a Beijing medical-imaging AI company, operated by 数坤（北京）网络科技股份有限公司 and set up in June 2017. It started with coronary CT angiography and now sells "digital doctor" products for the heart, brain, chest, abdomen, thyroid and breast, and musculoskeletal system, which it describes as hundreds of AI-doctor agents running on its own multimodal medical model, 数坤坤. The company says it serves nearly 5,000 medical institutions and produces more than 100 million diagnostic reports a year. It sells to hospitals and health-check centres; there is no self-serve product or price list, only a trial application for hospitals.
Regulatory approvals are its strongest card. By its own count it held 18 Chinese NMPA Class III certificates by August 2025, the most in the sector, and its 2020 coronary certificate was billed as China's first Class III approval for cardiovascular AI. Europe granted MDR CE marks in 2021, 2025 and 2026, and Japan's PMDA approved coronary, plaque and lung-nodule products. The FDA's database lists three 510(k) clearances: head-and-neck CTA and CT perfusion tools in 2023, filed by Yukun (Beijing) Technology, which match the FDA approvals in Shukun's own timeline, and CoronaryDoc in September 2025, filed by Careverse Technology, a Singapore company. Careverse is the brand under which Hong Kong distributor KLN Medical sells Shukun products. Earlier versions of this page counted two FDA clearances and 17 Chinese ones.
The money side is less clear. Shukun filed for a Hong Kong listing in September 2021; the prospectus, as reported by TMTPost, showed adjusted net losses of RMB 69.4 million in 2019 and RMB 75.2 million in the first half of 2021 alone. That application lapsed, and we found no current listing filing on either the Hong Kong or the Shanghai STAR market. Figures elsewhere for cash burn, margin and profitability could not be traced to a filing.
For ASEAN hospitals the relevant facts are a Singapore entity holding an FDA clearance and Singapore and Malaysia on Shukun's market map; local device registration still has to be confirmed per country.
Compiled by RECATOOLS from public sources: vendor documentation and pricing, code repositories and published reporting.
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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