(13 days)
The Neu Viz 16 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 with multislice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional imagers of the body from the same axial plane taken at different angles. The system is suitable for all patients.
The NeuViz 16 Multi-slice 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 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 text is a 510(k) summary for the NeuViz 16 Multi-slice CT Scanner System. This type of regulatory submission establishes substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the requested information regarding acceptance criteria, reported device performance from a study, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance studies, or training set details.
The document focuses on demonstrating that the NeuViz 16 is substantially equivalent to the Philips Brilliance CT16 Scanner System (K012009) based on:
- Intended Use: Both are whole-body computed tomography X-ray systems with multislice capabilities.
- Device Description: Both use similar materials, construction, operating principles (continuously rotating X-ray tube and detector array, fan beam principle), and software for acquisition, reconstruction, and archive/evaluation.
- Performance Standards: Adherence to various IEC and CFR standards for medical electrical equipment, radiation protection, and CT-specific requirements.
- Safety Assurance: Conformance to Good Manufacturing Practices (GMP), ISO 13485:2003, hazard analysis, software safety procedures, and electrical/mechanical safety standards (IEC 60601-1 series).
In essence, the "study" proving the device meets acceptance criteria in this context is the submission and FDA's acceptance of the argument for substantial equivalence, supported by technical specifications and adherence to recognized standards, rather than a clinical performance study with specific metrics.
Therefore, I cannot populate the requested table or answer the specific questions about clinical study design as the provided text pertains to a regulatory submission for substantial equivalence based on technical comparisons and standards compliance, not a clinical performance study.
§ 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.