# K172999: uWS-MR

- 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.
4 later devices descend from it; 1 cites it directly.
3 of 186 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
- K183164: uWS-MR (2019), 3 descendants of its own
- K192601: uWS-MR (2020), 2 descendants of its own
- K233186: uOmnispace.MR (2024), 1 descendant of its own
- K253077: uOmnispace.MR (2026), 0 descendants of its own

## Indications for use
uWS-MR 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 MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages. The Dynamic application is intended to provide a general post-processing tool for time course studies. The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series. MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data. The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images. The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images. The Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets. MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR 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/K172999
Methodology: https://510kreport.com/methodology