# K253163: Efai Ersuite CT Appendicitis Assessment System (Appen-CT-100)

- Pathway: 510(k) (Traditional)
- Applicant: Ever Fortune.Ai, Co., Ltd.
- Decided: Apr 22, 2026 after 208 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN170073 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193298: BriefCase, Aidoc Medical, Ltd. (2020) Summary page 5.

## Indications for use
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (EFAI APPENDICITIS) is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced abdominal CT images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of appendicitis. EFAI APPENDICITIS uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of EFAI APPENDICITIS are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

Source page: https://510kreport.com/device/K253163
Methodology: https://510kreport.com/methodology