Medical Image Post-processing Software (uOmnispace.CT)
Shanghai United Imaging Healthcare Co., Ltd.Medical Image Post-processing Software (uOmnispace.CT) is sophisticated software designed to help radiologists and clinicians view, manipulate, evaluate, and analyze CT medical images. It includes multiple specialized processing applications for lungs, heart, brain, liver, bone structure, vascular structures, and more, helping clinicians quantify and characterize anatomical and functional information to support diagnosis and treatment planning.
Intended Use
uOmnispace.CT is a software for viewing, manipulating, evaluating and analyzing medical images, including CT volume data sets with tools for various body regions such as lung, heart, brain, liver, bone, vascular system, and colon.
Technology
The device is a post-processing software platform for medical images, supporting standalone or integrated operation with cleared applications. It features deep learning algorithms for segmentation and analysis of multiple anatomical structures and dynamic CT perfusion analysis. It supports visualization, quantitative analysis, and reporting based on CT data, including dual energy CT for material composition analysis.
Performance
Performance verification was conducted on multiple AI-based segmentation and analysis algorithms across 100+ clinical cases for lungs, vessels, heart, and liver. Tests evaluated segmentation accuracy using Dice coefficients, achieving high values (e.g., lung segmentation 0.98, coronary artery extraction 0.916, liver segmentation 0.981), demonstrating accuracy and generalizability. No clinical or animal studies were required; software verification and validation per regulatory standards were documented.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/3/2024
8 months - 2
FDA Approval
5/14/2025
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uMR Jupiter2025 • 510K
- uMR Ultra2025 • 510K
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)2025 • 510K
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