Us2.ca is an AI-enabled medical device from Eko.Ai Pte Ltd. D/B/A Us2.Ai, listed by FDA (510(k), K250151) with a decision date of 2025-06-20. Review panel: Cardiovascular.
| FDA submission number | K250151 |
|---|---|
| Pathway | 510(k) |
| Company | Eko.Ai Pte Ltd. D/B/A Us2.Ai |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-06-20 |
| Decision | Substantially Equivalent |
| Product code | SDJ |
| Classification | Adjunctive Cardiac Amyloidosis Status Indicator |
| Device class | 2 |
| Regulation number | 870.2200 |
| Review time (calendar days) | 150 |
| Applicant country | SG |
Official FDA database record · FDA AI-enabled device list
More devices from Eko.Ai Pte Ltd. D/B/A Us2.Ai · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.