Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SingaporeLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Eko.Ai Pte Ltd. D/B/A Us2.Ai with 3 510(k) clearances and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Jun 20, 2025: Us2.ca.
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.
| Jun 20, 2025 | Us2.caK250151 · SDJ | 510(k) clearances |
| Jun 20, 2025 | Us2.caK250151 · Cardiovascular | AI-enabled devices |
| Apr 1, 2024 | Us2.v2K233676 · QIH | 510(k) clearances |
| Apr 1, 2024 | Us2.v2K233676 · Radiology | AI-enabled devices |
| Jul 27, 2021 | Us2.v1K210791 · QIH | 510(k) clearances |
| Jul 27, 2021 | Us2.v1K210791 · Radiology | AI-enabled devices |
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
