# K250040: uWS-Angio

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Sep 12, 2025 after 247 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K010938 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230955: syngo Application Software, Siemens Medical Solutions USA, Inc. (2023) Summary page 5.

## Indications for use
uWS-Angio is a post-processing software based on the uWS-Angio Basic for viewing, processing, evaluating and analyzing XA images. It has the following application: - The uWS-Angio 2D Vessel Analysis is intended to provide users a tool for quantifying the dimensions of coronary and peripheral vessels from 2D angiographic images. It supports vessel segmentation and output associated diameter parameters and curves. - The uWS-Angio Left Ventricular Analysis application is intended to provide users a tool for analyzing left ventricular functions. It supports editing contours of ventricular and outputs a set of parameters to show the ventricular functions and wall motion. - The uWS-Angio 2D Blood Flow Analysis application is intended to provide users a tool for analyzing blood flow of region of interest in peripheral vessels. It supports adding interest region and output multiple blood flow parameters for further perfusion analysis. - The uWS-Angio Stitching is intended to provide users a tool for lower extremities stitching bolus-chase acquired images into a stitching image.

Source page: https://510kreport.com/device/K250040
Methodology: https://510kreport.com/methodology