K253163
- 510(k) number
- K253163
- Device name
- EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
- Applicant
- Ever Fortune.Ai, Co., Ltd. TW
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2026-04-22
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253163.pdf
Official FDA record: K253163
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.