# K243632: uWS-Angio Basic

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: May 12, 2025 after 168 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: 16 generations back to K926514 (1993). 274 ancestors in all.
No later device cites it as a predicate yet.
4 of 275 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.
- K183170: uWS-CT, Shanghai United Imaging Healthcare Co., Ltd. (2019) Summary page 5.
- K232147: CAAS Workstation, Pie Medical Imaging BV (2024) Summary page 6.

## Indications for use
uWS-Angio Basic is intended to display and process XA (X-Ray Angiographic), CT (Computed Tomography), and MR (Magnetic Resonance) images that comply with the DICOM3.0 protocol.

Source page: https://510kreport.com/device/K243632
Methodology: https://510kreport.com/methodology