# K183170: uWS-CT

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Jun 24, 2019 after 220 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 K913770 (1991). 182 ancestors in all.
4 later devices descend from it; 3 cite 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)
- K173001: uWS-CT, Shanghai United Imaging Healthcare Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- 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 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. The CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway. The CT Brain Perfusion application is intended to calculate the parameters such as: CBV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in the brain. The CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function. The CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score. The CT Dynamic Analysis application is intended to provide visualization of the CT datasets over time with the 3D/4D display modes. The CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk. The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation.

Source page: https://510kreport.com/device/K183170
Methodology: https://510kreport.com/methodology