Cleerly ISCHEMIA is an AI-enabled medical device from Cleerly, Inc, listed by FDA (510(k), K231335) with a decision date of 2023-09-08. Review panel: Cardiovascular.
| FDA submission number | K231335 |
|---|---|
| Pathway | 510(k) |
| Company | Cleerly, Inc |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2023-09-08 |
| Decision | Substantially Equivalent |
| Product code | QXZ |
| Classification | Adjunctive Epicardial Vascular Physiologic Status Indicator |
| Device class | 2 |
| Regulation number | 870.2200 |
| Review time (calendar days) | 123 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Cleerly, Inc · All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.