uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co.,Ltd.The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis and uCT ATLAS with uWS-CT-Dual Energy Analysis are advanced CT imaging systems that produce cross-sectional whole-body images using X-rays. They incorporate AI-based technologies to enhance image reconstruction, reduce artifacts, and improve diagnostic quality, particularly for cardiac imaging and lung cancer screening. The systems support low dose CT for early lung nodule detection and use dual energy imaging for detailed tissue characterization.
Intended Use
The device is intended to produce cross-sectional images of the whole body by computer reconstruction of X-ray transmission data at different angles and planes. It is applicable to head, whole body, cardiac, and vascular imaging. Also intended for low dose CT lung cancer screening for early detection of lung nodules that may represent cancer, within established program criteria.
Technology
The system integrates multiple AI-driven reconstruction and post-processing functions, including CardioBoost, AIIR (iterative reconstruction), CardioXphase (optimal cardiac phase selection), Motion Freeze (motion artifact reduction), Ultra EFOV (extended field of view), and CardioCapture (cardiac motion correction). These functions leverage deep learning to optimize image quality, reduce radiation dose, and improve diagnostic accuracy.
Performance
Non-clinical bench testing and reader studies were conducted demonstrating that AI-based reconstruction methods improve image quality compared to traditional methods, reduce noise, enhance low contrast detectability, and effectively reduce motion artifacts. Reader evaluations confirmed sufficiency for diagnosis and equivalence or superiority to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/22/2024
5 months - 2
FDA Approval
5/16/2025
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
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.