# K220332: uMR Omega with uWS-MR-MRS

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Oct 27, 2022 after 265 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K971684 (1997). 39 ancestors in all.
7 later devices descend from it; 2 cite it directly.
4 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193200: uMR Omega, Shanghai United Imaging Healthcare Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K230152: uMR Omega (2023), 6 descendants of its own
- K240540: uMR Omega (2024), 3 descendants of its own
- K243122: uMR Omega (2025), 2 descendants of its own
- K243547: uMR Ultra (2025), 1 descendant of its own
- K233673: uMR Jupiter (2024), 1 descendant of its own

## Indications for use
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan. 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. The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images. The United Neuro is intended to view, manipulate, and evaluate MR neurological images. The MR Cardiac Analysis application is intended to be used for viewing, post-processing and quantitative evaluation of cardiac magnetic resonance data.

Source page: https://510kreport.com/device/K220332
Methodology: https://510kreport.com/methodology