# K242292: uAI Easy Triage ICH

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Intelligence Co., Ltd.
- Decided: Sep 24, 2024 after 53 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: 4 generations back to DEN170073 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221716: CINA, Avicenna.Ai (2022) Summary page 6.

## Indications for use
uAI Easy Triage ICH is a radiological computer-assisted triage and notification software device indicated for analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected positive findings of Intracranial Hemorrhage (ICH).

Source page: https://510kreport.com/device/K242292
Methodology: https://510kreport.com/methodology