EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is an AI-enabled medical device from Ever Fortune.AI, Co., Ltd., listed by FDA (510(k), K242821) with a decision date of 2025-02-20. Review panel: Radiology.
| FDA submission number | K242821 |
|---|---|
| Pathway | 510(k) |
| Company | Ever Fortune.AI, Co., Ltd. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-02-20 |
| 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) | 155 |
| Applicant country | TW |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.