The uCT 780 is a computed tomography (CT) system designed to produce cross-sectional images of the body including head, neck, chest, cardiac and vascular regions. It offers advanced AI-driven image reconstruction to improve image quality and reduce radiation dose, supporting lung cancer screening and various diagnostic tasks. This helps clinicians obtain clearer images for diagnosis while lowering radiation exposure for patients.
Intended Use
uCT 780 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). It is intended for low dose CT lung cancer screening for early detection of lung nodules that may represent cancer, to be performed under approved protocols.
Technology
The system includes a post-processing software, uWS-CT-Dual Energy Analysis, which analyzes CT images obtained at different tube voltages/currents to visualize chemical composition differences using combined low and high energy spectra images. It also includes the DELTA (Deep Recon) AI-based deep learning reconstruction algorithm embedded in acquisition and processing software, improving image noise reduction, low contrast detectability and spatial resolution while allowing dose reduction compared to traditional filtered back projection (FBP).
Performance
Performance testing of the DELTA algorithm included both bench (phantom) and clinical evaluations. Bench tests covered image quality metrics such as CT HU number, noise power spectrum, low contrast detectability (LCD), and spatial resolution, demonstrating better or equivalent image quality compared with filtered back projection (FBP) at lower doses. Clinical evaluation consisted of reader studies by board-certified radiologists, assessing image quality and confirming that DELTA provides equivalent or improved image quality at reduced radiation doses. Validation and test datasets covered multiple body regions and dose levels, meeting acceptance criteria with no new safety concerns identified.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/19/2024
8 months - 2
FDA Approval
1/7/2025
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uCT 5502025 • 510K
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)2024 • 510K
- uDR 780i2024 • 510K
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