# K240291: Efai Cardiosuite Cta Acute Aortic Syndrome Assessment System

- Pathway: 510(k) (Traditional)
- Applicant: Ever Fortune.Ai, Co., Ltd.
- Decided: Apr 8, 2024 after 67 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: 5 generations back to DEN170073 (2018). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222329: BriefCase, Aidoc Medical, Ltd. (2022) Summary page 4.

## Indications for use
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) is a radiological computer aided triage and notification software indicated for use in the analysis of chest or chest-abdomen CTA in adults aged 22 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of aortic dissection (AD) or aortic intramural hematoma (IMH) pathology. EFAI AASCTA uses an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. BFAI AASCTA is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out AAS or otherwise preclude clinical assessment of computed tomography angiography cases.

Source page: https://510kreport.com/device/K240291
Methodology: https://510kreport.com/methodology