uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is an advanced CT scanner designed to produce cross-sectional images of various body regions, including head, whole body, cardiac, and vascular areas. It integrates deep learning for image reconstruction to enhance image quality and reduce noise, and includes software for dual energy analysis to differentiate tissue types based on their chemical composition. This aids clinicians in lung cancer screening and detailed anatomical evaluation, supporting early diagnosis and treatment.
Intended Use
uCT ATLAS Astound is a computed tomography x-ray system, intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data at different angles and planes, for head, whole body, cardiac, and vascular CT. It is intended for low dose lung cancer screening for early lung nodule detection within established protocols.
Technology
The device features a multi-slice CT scanner with 40 mm z-coverage, 0.25 second rotation speed, 82 cm bore size, and deep learning image reconstruction (Deep IR/AIIR). It acquires dual energy CT images at varying tube voltages/currents, enabling post-processing software to analyze tissue chemical composition through combined low and high energy image data.
Performance
The device underwent non-clinical testing including dosimetry, image performance, and software verification/validation demonstrating substantial equivalence to the predicate device. Standards followed include IEC 60601 series, NEMA XR standards, ISO 14971 risk management, cybersecurity controls, and clinical image evaluation by a board-certified radiologist confirmed diagnostic image quality.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/29/2022
4 months - 2
FDA Approval
2/16/2023
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