(37 days)
The NeuViz Dual systems are intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.
The NeuViz Dual Multi-slice CT Scanner System -NeuViz Dual (H) and NeuViz Dual (L) - are intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
The NeuViz Dual systems are whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and multi-slice capability of 2 slices simultaneously. There are two variants with different tube capacity: NeuViz Dual (H) and NeuViz Dual (L). The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.
This document is a 510(k) premarket notification for the NeuViz Dual Multi-slice CT Scanner System. It describes the device, its intended use, and claims substantial equivalence to a predicate device.
Based on the provided information, the acceptance criteria and study details are not present in this summary. This document primarily focuses on establishing substantial equivalence to a predicate device (CT-C3000DUAL and CT-C2800DUAL Family) rather than presenting a performance study against specific acceptance criteria.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or training set details from the provided text.
The closest information available is the "Statement of Substantial Equivalence," which argues that the NeuViz Dual systems are "of comparable type and substantially equivalent to the CT-C300DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems (K041542) that comply with the same or equivalent standards and has the same intended uses." This implies that the device is deemed acceptable if it meets the same standards and performance as the predicate device, but no specific performance metrics or a study demonstrating this are 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.