Tempus ECG-Low EF is an AI-enabled medical device from Tempus AI, Inc., listed by FDA (510(k), K250119) with a decision date of 2025-07-15. Review panel: Cardiovascular.
| FDA submission number | K250119 |
|---|---|
| Pathway | 510(k) |
| Company | Tempus AI, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-07-15 |
| Decision | Substantially Equivalent |
| Product code | QYE |
| Classification | Reduced Ejection Fraction Machine Learning-Based Notification Software |
| Device class | 2 |
| Regulation number | 870.2380 |
| Review time (calendar days) | 180 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.