Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Heuron with 5 510(k) clearances and 2 AI-enabled devices. The most recent is a 510(k) clearance dated May 15, 2024: Heuron ICH.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 15, 2024 | Heuron ICHK233247 · QAS | 510(k) clearances |
| May 15, 2024 | Heuron ICHK233247 · Radiology | AI-enabled devices |
| Oct 13, 2023 | Veuron-Brain-pAb3K231642 · LLZ | 510(k) clearances |
| Oct 13, 2023 | Veuron-Brain-pAb3K231642 · Radiology | AI-enabled devices |
| Jul 12, 2022 | Veuron-Brain-mN1K203279 · LNH | 510(k) clearances |
| Feb 4, 2022 | Veuron-Brain-pAb2K213801 · LLZ | 510(k) clearances |
| Jan 15, 2021 | Veuron-Brain-pAbK203142 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
