# K253726: uAngio AVIVA CX

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Aug 21, 2026 after 270 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K801623 (1980). 59 ancestors in all.
No later device cites it as a predicate yet.
4 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243376: uAngio AVIVA CX, Shanghai United Imaging Healthcare Co., Ltd. (2025) Summary page 5.

## Indications for use
The system is used to perform image guidance in diagnostic, intervention and surgical procedures. Procedures that can be performed with the system include cardiac angiography, neuro-angiography, vascular and non-vascular angiography, rotational angiography and whole body radiographic/fluoroscopic procedures.

Source page: https://510kreport.com/device/K253726
Methodology: https://510kreport.com/methodology