uCT ATLAS with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.The uCT ATLAS with uWS-CT-Dual Energy Analysis is a multi-slice CT scanner designed for producing cross-sectional images of the whole body and specific organs using advanced imaging technology. It features fast scanning with high spatial and temporal resolution, low radiation dose, and AI-based enhancements for image quality and patient positioning. Its dual energy analysis software helps differentiate tissue composition using CT images acquired at different energy levels, aiding diagnostic insights.
Intended Use
uCT ATLAS 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. It is applicable to head, whole body, cardiac, and vascular CT imaging. It is intended for low dose lung cancer screening to detect lung nodules that may represent cancer.
Technology
The device includes a multi-slice CT scanner with a 320-row 0.5 mm slice detector, 0.25 s rotation speed, and 82 cm bore size. It features Deep IR, a new generation reconstruction combining model-based iterative reconstruction and deep learning to reduce image noise and artifacts while improving detectability and spatial resolution. It also provides patient positioning assistance and low dose scanning with fast volumetric capability. The dual energy analysis software uses CT images acquired at different tube voltages/currents to visualize chemical composition via multiple energy spectra.
Performance
Non-clinical performance testing including dosimetry, image performance, electrical safety, EMC, biocompatibility, software verification and validation were conducted. The device meets various international standards (e.g. IEC, NEMA) and FDA guidance. Cybersecurity measures are in place. Clinical evaluation of applications was performed but no clinical study was included in the submission. Testing confirmed safety and effectiveness are comparable to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/23/2020
8 months - 2
FDA Approval
8/11/2021
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