uOmnispace.MR
Shanghai United Imaging Healthcare Co., Ltd.uOmnispace.MR is advanced software developed by Shanghai United Imaging Healthcare Co., Ltd. that helps clinicians view, process, and analyze magnetic resonance (MR) images across various clinical applications such as brain, breast, cardiac, vascular, and neurological imaging. It supports interpretation and evaluation by providing tools for stitching, dynamic studies, spectroscopy, perfusion, vessel analysis, cardiac function analysis, and flow analysis, enabling improved diagnostic workflows and patient care.
Intended 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.
Technology
This software is a post-processing tool based on the uOmnispace platform that supports multiple advanced MR imaging applications including Stitching, Dynamic studies, MR Spectroscopy (SVS and CSI), MAPs statistical functions, Breast Evaluation, Brain Perfusion, Vessel Analysis, DCE analysis, Neurological evaluation, Cardiac Function, and Flow Analysis. It includes AI-driven segmentation for cardiac ventricular analysis.
Performance
Performance testing including software verification, validation, and clinical data-based evaluation of the cardiac ventricular segmentation AI algorithm was conducted, demonstrating equivalence and safety compared to predicate devices. The Dice coefficient for segmentation was 1.00, confirming high consistency. No clinical or animal studies were required. Testing also covered new parameters and algorithms such as SER, T1rho, and semi-automatic contour segmentation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/28/2023
6 months - 2
FDA Approval
4/17/2024
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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