Hyper Insight - ICH is an AI-enabled medical device from SK Inc., listed by FDA (510(k), K240353) with a decision date of 2024-07-01. Review panel: Radiology.
| FDA submission number | K240353 |
|---|---|
| Pathway | 510(k) |
| Company | SK Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2024-07-01 |
| Decision | Substantially Equivalent |
| Product code | QAS |
| Classification | Radiological Computer-Assisted Triage And Notification Software |
| Device class | 2 |
| Regulation number | 892.2080 |
| Review time (calendar days) | 147 |
| Applicant country | KR |
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.