iCAC Device is an AI-enabled medical device from Bunkerhill, Inc, listed by FDA (510(k), K230223) with a decision date of 2023-04-25. Review panel: Radiology.
| FDA submission number | K230223 |
|---|---|
| Pathway | 510(k) |
| Company | Bunkerhill, Inc |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-04-25 |
| Decision | Substantially Equivalent |
| Product code | JAK |
| Classification | System, X-Ray, Tomography, Computed |
| Device class | 2 |
| Regulation number | 892.1750 |
| Review time (calendar days) | 89 |
| 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.