uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis

The uCT ATLAS Astound and uCT ATLAS Computed Tomography X-Ray Systems, recognized as Class II medical devices, are designed for comprehensive whole-body imaging, leveraging advanced dual-energy technology for detailed tissue composition analysis and various specialized functions. Their core science involves utilizing different energy spectra combined with sophisticated post-processing (uWS-CT-Dual Energy Analysis) and features like AIIR and CardioXphase to enhance image quality, reduce dose, and optimize applications such as low-dose lung cancer screening and cardiac imaging.

The uCT ATLAS Astound and uCT ATLAS with uWS-CT-Dual Energy Analysis, developed by Shanghai United Imaging Healthcare Co.,Ltd., have received a substantial equivalence determination on May 16, 2025. This regulatory approval allows the company to market these Class II Computed Tomography X-Ray Systems, affirming their safety and effectiveness for clinical use across various applications. These CT systems are engineered to generate cross-sectional images for comprehensive whole-body examinations, encompassing head, cardiac, vascular, and general X-ray CT applications, including specialized low-dose lung cancer screening. A key scientific aspect is the integration of the uWS-CT-Dual Energy Analysis post-processing software, which leverages images from different energy spectra to derive detailed information on tissue composition. Furthermore, the systems incorporate advanced functionalities like CardioXphase, CardioBoost, Cardio Capture, AIIR, Motion Freeze, and Ultra EFOV. The determination of substantial equivalence was supported by rigorous non-clinical testing, including bench tests and reader studies.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What are the specific quantitative metrics used in the uWS-CT-Dual Energy Analysis to differentiate tissue composition, and how do they correlate with pathology?; How do the advanced functions such as CardioXphase, CardioBoost, and Motion Freeze specifically improve image quality and reduce motion artifacts in cardiac CT scans?; What were the exact non-clinical testing protocols, including bench tests and reader studies, that validated the substantial equivalence of these systems, especially concerning new features like AIIR and Ultra EFOV?; Can the uCT ATLAS systems provide clinical advantages for patient populations requiring ultra-low dose imaging beyond lung cancer screening, such as pediatric patients?; What are the long-term data on image quality, diagnostic accuracy, and radiation dose management for these devices in a real-world clinical setting post-market clearance?