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

Substantially Equivalent

Ever Fortune.Ai, Co., Ltd.

Clearance details

Applicant: Ever Fortune.Ai, Co., Ltd.
Product code: Code QAS
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 ↗

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