Aorta-CAD is an AI-enabled medical device from Imagen Technologies, Inc, listed by FDA (510(k), K213353) with a decision date of 2022-09-20. Review panel: Radiology.
| FDA submission number | K213353 |
|---|---|
| Pathway | 510(k) |
| Company | Imagen Technologies, Inc |
| Review panel (specialty) | Radiology |
| FDA decision date | 2022-09-20 |
| Decision | Substantially Equivalent |
| Product code | MYN |
| Classification | Analyzer, Medical Image |
| Device class | 2 |
| Regulation number | 892.2070 |
| Review time (calendar days) | 347 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Imagen Technologies, Inc · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.