K242821
- 510(k) number
- K242821
- Device name
- EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
- Applicant
- Ever Fortune.Ai, Co., Ltd. TW
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2025-02-20
- Date received
- 2024-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K242821.pdf
Official FDA record: K242821
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.