(9 days)
The CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner 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 CT-C300DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems are a whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and multi-slice capability of up to 2 slices simultaneously . 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) summary for the Neusoft CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems. It establishes the substantial equivalence of these devices to a predicate device (CT-C3000 system, K020913).
However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document is focused on regulatory compliance and establishing substantial equivalence based on the device's technical characteristics and intended use, rather than presenting a performance study with detailed acceptance criteria.
Therefore, I cannot extract the requested information. The document primarily describes:
- General Information: Trade name, common name, classification, manufacturer, and submitter details.
- Intended Uses: To produce cross-section images of the head and whole body by computer reconstruction of X-ray transmission data.
- Device Description: Whole-body X-ray computed tomography scanner with dual-slice capability, continuously rotating tube-detector system, and interactive software.
- Predicate Device: CT-C3000 system (K020913).
- Statement of Substantial Equivalence: Comparing the new devices to the predicate device in terms of type, standards compliance, and intended uses.
- FDA Approval Letter: Confirming the substantial equivalence determination.
To answer your specific questions, a different type of document (e.g., a clinical study report or a detailed performance and validation report) would be needed.
§ 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.