# K173001: uWS-CT

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Nov 7, 2018 after 406 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: 11 generations back to K913770 (1991). 181 ancestors in all.
5 later devices descend from it; 1 cites it directly.
3 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123920: Syngo.Via, Siemens AG Medical Solutions (2013) Summary page 4.

## Most influential descendants
- K183170: uWS-CT (2019), 4 descendants of its own
- K233209: uOmnispace.CT (2024), 1 descendant of its own
- K242624: Medical Image Post-processing Software (uOmnispace.CT) (2025), 0 descendants of its own
- K243632: uWS-Angio Basic (2025), 0 descendants of its own
- K240411: uAI Portal (2024), 0 descendants of its own

## Indications for use
uWS-CT is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions in lung or liver. The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon. The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. The CT Lung Density application is intended to provide the user a number of density parameters and structure information for evaluating tomogram scans of the lung. The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating, and evaluating CT vascular images. The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.

Source page: https://510kreport.com/device/K173001
Methodology: https://510kreport.com/methodology