# K193271: uAI EasyTriage-Rib

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Intelligence Co., Ltd.
- Decided: Jan 15, 2021 after 416 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192901: HealthVCF, Zebra Medical Vision, Ltd. (2020). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K213319: Viz ANEURYSM, Viz ANX (2022), 2 descendants of its own
- K230074: Rapid Aneurysm Triage and Notification (2023), 0 descendants of its own
- K223443: Viz AAA (2023), 0 descendants of its own

## Indications for use
uAI EasyTriage-Rib is a radiological computer-assisted triage and notification software device for analysis of CT chest images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing trauma studies with suspected positive findings of multiple (3 or more) acute rib fracture(s). uAI EasyTriage-Rib uses an artificial intelligence algorithm to analyze images and highlight studies with suspected multiple (3 or more) acute rib fracture(s) in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The user is presented with notifications of cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of uAI EasyTriage-Rib, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Notified radiologists who read the original medical images are responsible for the diagnostic decision.

Source page: https://510kreport.com/device/K193271
Methodology: https://510kreport.com/methodology