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The NeuViz Spiral CT Scanner System is intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles. This device will not be used for breast disease diagnoses.

The NeuViz Spiral CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.

The provided documents do not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

The documents are a 510(k) summary for the Neusoft NeuViz Spiral CT Scanner System, focusing on general information, intended uses, device description, and a statement of substantial equivalence to a predicate device (CT-C3000 Spiral CT Scanner System - K020913). It also contains the FDA's clearance letter.

This type of submission primarily attests that the new device is as safe and effective as a previously cleared device. It generally does not include detailed performance studies with acceptance criteria in the manner one might find for, for example, an AI-driven diagnostic device. For standard CT scanners, the "performance" is often evaluated against established standards for image quality (e.g., spatial resolution, contrast resolution, noise), radiation dose, and compliance with electrical/safety standards, rather than clinical diagnostic accuracy metrics.

Therefore, I cannot fulfill your request for the specific table and study details as they are not present in the provided text.

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