uOmnispace.MI
Shanghai United Imaging Healthcare Co., Ltd.uOmnispace.MI is an advanced software platform designed to help healthcare professionals view and analyze medical images from PET, CT, MR, and SPECT scans. It facilitates tasks such as image registration, lesion segmentation, and statistical analysis, supporting clinical workflows in oncology, neurology, and cardiology. The software integrates multiple applications including fusion imaging, dynamic analysis, brain scan quantification, and cardiac function analysis, thereby assisting clinicians in making timely and accurate diagnoses.
Intended Use
Software for viewing, processing, evaluating and analyzing PET, CT, MR, SPECT images within healthcare institutions. Includes tools for dedicated reporting in oncology, neurology, cardiology and supports image registration, lesion segmentation, and quantitative analysis.
Technology
The software includes multiple applications for fusion imaging, oncology dedicated follow-ups (image registration, lesion segmentation), dynamic PET data analysis, PET brain scan quantification, and cardiac short axis reconstruction with perfusion and function analysis. Utilizes deep learning-based algorithms for spine and rib labeling with performance validation.
Performance
Software verification and validation done including hazard analysis with moderate level of concern. No animal or clinical studies required. Performance testing included validation of deep learning spine and rib labeling algorithms on large, diverse datasets showing high accuracy and robustness across subgroups. Acceptance criteria based on scoring system exceeded. Testing used multi-manufacturer CT images with thorough clinical annotation and independent train-test data separation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/28/2023
2 months - 2
FDA Approval
12/20/2023
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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