uAI Portal is a medical imaging software system developed by Shanghai United Imaging Intelligence Co., Ltd. It provides tools to view, manipulate, and evaluate CT angiography studies focused on vascular structures within various anatomical regions including lower extremities, head and neck, coronary arteries, pulmonary arteries, and aorta. The software uses AI-based segmentation algorithms to help clinicians analyze vessel structures accurately and efficiently, making it easier to interpret complex vascular imaging data and facilitating clinical decision-making.
Intended Use
uAI Portal is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It includes specific tools for evaluating CTA images of lower extremities, head and neck, coronary arteries, pulmonary arteries, and aorta.
Technology
The system parses DICOM images and utilizes AI-generated automatic segmentation results to reconstruct medical images. The software supports various viewing modes and image manipulation features, including VR, MIP, MPR, and others. Segmented results are stored and retrievable for display and further analysis within the software. Users can save or print images and results, and adjust configurations as needed for clinical workflows.
Performance
The software underwent extensive software verification and validation per FDA guidance and was clinically validated using 150 CT angiography images from diverse sources covering different demographics, equipment vendors, and imaging protocols. AI segmentation algorithms were compared against expert-annotated ground truth by radiologists, showing high Dice similarity coefficients across vascular structures (average Dice scores ranging approximately from 0.80 to 0.98). No clinical or animal studies were required, and cybersecurity and risk management conform to relevant standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/12/2024
6 months - 2
FDA Approval
9/6/2024
Other devices from Shanghai United Imaging Intelligence Co., Ltd.
- uAI Easy Triage ICH2024 • 510K
- uMR 6802023 • 510K
- uAI EasyTriage-Rib2021 • 510K
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