uOmnispace.CT
Shanghai United Imaging Healthcare Co., Ltd.uOmnispace.CT is a comprehensive medical image management and processing software mainly for CT images, developed by Shanghai United Imaging Healthcare. It provides various AI-driven analysis tools including lung nodule detection, brain perfusion analysis, cardiovascular and liver evaluations, and more. This software supports clinical interpretation, visualization, and quantitative assessment, helping clinicians diagnose and plan treatments more efficiently across multiple organ systems.
Intended Use
uOmnispace.CT is a software for viewing, manipulating, evaluating and analyzing medical images to support interpretation and evaluation of CT examinations within healthcare institutions, including specialized analysis applications for multiple organs and pathologies.
Technology
uOmnispace.CT is a post-processing software based on the uOmnispace platform that accepts UIH CT images and includes AI-based algorithms for segmentation, labeling, and quantitative analysis of multiple organs and pathologies. It supports multi-energy CT analysis (dual energy) and advanced visualization including 3D/4D display modes.
Performance
Performance testing included software verification and validation, and clinical data evaluation with multiple AI algorithms (spine labeling, rib labeling, TAVR analysis), showing high accuracy and generalizability across diverse patient subgroups. No clinical or animal studies required. Testing showed average scores exceeding acceptance criteria and demonstrated safety and effectiveness comparable to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/28/2023
7 months - 2
FDA Approval
5/17/2024
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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