510(k) Report

FDA applicant

Heuron Co., Ltd.

Incheon, KR5 decisions2021–20240 recalls

FDA records 5 decisions for Heuron Co., Ltd. (Incheon, KR) from 2021 to 2024: 5 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QAS (Radiological Computer-Assisted Triage And…). Since 2016 its 510(k)s took a median of 130 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Heuron Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12022: 22023: 12024: 1
2021high 2 (2022) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Heuron Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Heuron Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological3decisions
  • QASRadiological Computer-Assisted Triage And Notification Software1decision
  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 130 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 136 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203142Veuron-Brain-pAbHeuron Co., Ltd. · 20212cite it
  • K213801Veuron-Brain-pAb2Heuron Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K233247Heuron ICHHeuron Co., Ltd. · 2024
  • K231642Veuron-Brain-pAb3Heuron Co., Ltd. · 2023
  • K203279Veuron-Brain-mN1Heuron Co., Ltd. · 2022
  • K213801Veuron-Brain-pAb2Heuron Co., Ltd. · 2022
  • K203142Veuron-Brain-pAbHeuron Co., Ltd. · 2021

All 5 as Heuron Co., Ltd. →