EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
K-Number: K253163 · 2026-04-22
ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2026-04-22
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2026-04-22 under approval number K253163. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)?
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) is a medical device that received FDA 510(k) clearance on 2026-04-22. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K253163.
When was EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) approved by the FDA?
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) received FDA 510(k) clearance on 2026-04-22, under approval number K253163.
What company makes EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)?
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) is manufactured by Ever Fortune.Ai, Co., Ltd..
What is the FDA product code for EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)?
The FDA product code for EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) is QAS.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.