Cardiac Guidance is an AI-enabled medical device from Caption Health, Inc., listed by FDA (510(k), K243065) with a decision date of 2025-01-15. Review panel: Radiology.
| FDA submission number | K243065 |
|---|---|
| Pathway | 510(k) |
| Company | Caption Health, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-01-15 |
| Decision | Substantially Equivalent |
| Product code | QJU |
| Classification | Image Acquisition And/Or Optimization Guided By Artificial Intelligence |
| Device class | 2 |
| Regulation number | 892.2100 |
| Review time (calendar days) | 110 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.