(12 days)
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.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.