EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)— 510(k) K253163

Name: FDA 510(k) clearance K253163
Creator: U.S. Food and Drug Administration
Published: 2026-04-22

Substantially Equivalent

Ever Fortune.Ai, Co., Ltd.

FDA 510(k) clearance K253163 for EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100), Substantially Equivalent on 2026-04-22. Applicant: Ever Fortune.Ai, Co., Ltd.. Device class: 2.

Summary

Ever Fortune.Ai's EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) is filed under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Class II, 21 CFR 892.2080. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Ever Fortune.Ai filed from Taichung City, Taiwan. The decision came 208 calendar days after FDA received it (September 26, 2025 to April 22, 2026).

Clearance details

Applicant: Ever Fortune.Ai, Co., Ltd.
Product code: Product code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2025-09-26
Decision date: 2026-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.