uCT ATLAS with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd. • Radiology • 08/11/2021
Device Purpose
The uCT ATLAS system is an advanced computed tomography scanner leveraging wide detector coverage, rapid acquisition, and AI-enhanced image reconstruction (Deep IR) to provide high-quality diagnostic images across various anatomical regions, including cardiac and low-dose lung screening, with reduced noise and artifacts. The accompanying uWS-CT-Dual Energy Analysis software further enhances diagnostic capabilities by enabling material differentiation and chemical composition analysis through the processing of images acquired at different energy levels.
Summary
The uCT ATLAS with uWS-CT-Dual Energy Analysis is a multi-slice computed tomography (CT) x-ray system designed for producing cross-sectional images of the whole body, including head, cardiac, and vascular applications, as well as low-dose CT lung cancer screening. Key hardware features include a 160 mm z-coverage with a 320-row detector, a 0.25s rotation speed for high temporal resolution, an 82 cm bore, and a 318 kg table load capacity. The system incorporates a novel reconstruction method called Deep IR (or AIIR), which combines model-based iterative reconstruction with deep learning technology to reduce image noise and artifacts, while improving low contrast detectability and spatial resolution. It also features uAI Vision for patient positioning assistance and is engineered for lower radiation dose compared to previous generations, with capabilities for whole organ coverage and fast scanning for dynamic and vascular imaging. The uWS-CT-Dual Energy Analysis is a software package that processes CT images acquired at different tube voltages and/or currents of the same anatomical location. It leverages the principle that different materials exhibit varying attenuation coefficients depending on x-ray energy, thereby providing information on the chemical composition of scanned body materials. This software combines images from low and high energy spectra to visualize this compositional information and can generate images at multiple energies. Non-clinical performance data, including dosimetry, image performance tests, electrical safety, EMC, and software verification and validation, were provided to support its technological characteristics. The device conforms to various industry standards for performance, safety, and cybersecurity.
AI Regulatory Concerns
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Keywords
Device Metadata
Relevant Clinical Questions
- Q1. What is the measurable improvement in low-contrast detectability and spatial resolution provided by the Deep IR (AIIR) reconstruction method compared to conventional iterative reconstruction, especially at reduced radiation doses?; How does the uWS-CT-Dual Energy Analysis software specifically quantify material composition, and what is its accuracy for differentiating tissues with similar attenuation coefficients at single energy levels?; What are the specific mechanisms by which the uAI Vision patient positioning assistance improves scan accuracy and efficiency?; For cardiac imaging, what is the typical reduction in motion artifacts achieved with the 0.25s rotation speed and features like CardioXphase and CardioCapture?; How does the system ensure consistent image quality and diagnostic performance across the specified range of patient sizes and anatomical regions, particularly when utilizing low-dose protocols and deep learning-based features?
Risk Classification
ESL AnalysisFDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement
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Powered by SBOMator™Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.
Supply Chain BOM Evidence
Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.
Analysis:
• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.
• Evidence of SBOM, ML-BOM, HBOM detected in AI-generated device summary.
• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.
• Not detected in AI-generated device summary: SaaSBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.
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