# K253077: uOmnispace.MR

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Apr 22, 2026 after 211 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 15 generations back to K913770 (1991). 185 ancestors in all.
No later device cites it as a predicate yet.
3 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233186: uOmnispace.MR, Shanghai United Imaging Healthcare Co., Ltd. (2024) Summary page 6.

## Indications for use
uOmnispace.MR is a software solution intended to be used for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The uOmnispace.MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages. The uOmnispace.MR Dynamic application is intended to provide a general post-processing tool for time course studies. The uOmnispace.MR 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 uOmnispace.MR 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 uOmnispace.MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images. The uOmnispace.MR Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets. The uOmnispace.MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images. The uOmnispace.MR DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images. The uOmnispace.MR United Neuro is intended to view, manipulate, and evaluate MR neurological images. The uOmnispace.MR Cardiac Function is intended to view, evaluate functional analysis of cardiac MR images. The uOmnispace.MR Flow Analysis is intended to view, evaluate flow analysis of flow MR images. The uOmnispace.MR Cardiac Perfusion is intended to view, process and analyze MR cardiac perfusion images. The uOmnispace.MR Cardiac Viability is intended to view, process and analyze MR late gadolinium enhancement images. The uOmnispace.MR Diffusion Analysis is intended to view, process and analyze MR diffusion images. The uOmnispace.MR SWI+ is intended to view and generate susceptibility weighted images (SWI) and quantitative susceptibility mapping (QSM) images. The uOmnispace.MR Multiplex Analysis is intended to generate and view multiple virtual contrast images. The uOmnispace.MR ASL is intended to view, process and analyze MR arterial spin labeling (ASL) images.

Source page: https://510kreport.com/device/K253077
Methodology: https://510kreport.com/methodology