The uCT 550 is a computed tomography (CT) X-ray system designed to produce detailed cross-sectional images of the whole body, including head, neck, cardiac, and vascular regions. It uses advanced AI-based deep learning algorithms to enhance image quality, reduce noise, and allow for dose reduction. This system helps clinicians with better diagnostic imaging across multiple body regions with improved accuracy and efficiency.
Intended Use
The uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac and vascular.
Technology
The device consists of a CT gantry with high voltage generator, X-ray tube, collimator, and detectors, a patient table, operating console, power supply cabinet, vital signal monitoring gated control unit, 3D camera, system software, and accessories. It employs AI-based deep learning algorithms such as DELTA (Deep Recon) for image noise reduction, spatial resolution enhancement, and dose reduction. Additional AI features include EasyRange for automatic scan range recommendation and Motion Freeze for correcting patient head motion.
Performance
Performance testing included bench testing using phantoms for image quality metrics, low contrast detectability, noise reduction, and spatial resolution according to IEC standards. Clinical evaluation involved a reader study with 44 cases across various body parts and doses, showing the AI-enhanced images met or exceeded criteria compared to filtered back projection. The device demonstrated improved image quality and dose reduction capability without compromising diagnostic requirements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/26/2024
8 months - 2
FDA Approval
1/14/2025
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uCT 7802025 • 510K
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)2024 • 510K
- uDR 780i2024 • 510K
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