NeuViz 128 Multi-Slice CT Scanner System
Neusoft Medical Systems Co., Ltd.The NeuViz 128 Multi-Slice CT Scanner System by Neusoft Medical Systems is a CT scanner designed for whole body imaging, producing cross-sectional images to help clinicians diagnose various medical conditions. It incorporates advanced AI-powered reconstruction methods to reduce noise and enhance image quality, potentially lowering radiation dose for patients while improving diagnostic capabilities.
Intended Use
The NeuViz 128 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array to generate cross-sectional images.
Technology
The device consists of a gantry with a 72cm bore, continuously rotating X-ray tube and detector array, and includes three reconstruction methods: Filtered Back Projection (FBP), ClearView (iterative reconstruction), and ClearInfinity (deep learning based noise reduction for low dose imaging).
Performance
Performance testing included engineering bench testing, phantom studies, and reader studies. ClearView and ClearInfinity reconstructions demonstrated reduced radiation dose (up to 75-85% with ClearInfinity) while improving low contrast detectability and noise reduction compared to FBP. Clinical image evaluation showed equivalent or better diagnostic quality at normal and low doses. Cybersecurity compliance and risk analysis were conducted according to standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/26/2023
8 months - 2
FDA Approval
10/11/2023
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