(24 days)
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results.
The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
If the spectral imaging option is included on the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.
GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus nonuric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.
The Revolution CT family of products including Revolution CT. Revolution CT ES and Revolution Apex are multi-slice CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. The Revolution CT ES has 128 detector rows with 80mm coverage while the Revolution CT and Revolution Apex have 256 detector rows with 160mm detector coverage.
GE has modified the cleared Revolution CT (K163213) within our design controls to include the SmartScout Option to offer optimized thermal management and improved workflow. The SmartScout mode, if selected by the user, allows for performance of tube warmups during patient scout scanning, eliminating user intervention and wait times for tube warmup. It quides the user to the optimal scout scanning parameters, in order to optimize image quality and dose during patient scanning. The user will still have access to the Regular Scout mode where all traditional routine scout technique settings can be accessed and manually prescribed, such as kV, mA, and cradle speed. SmartScout is an added capability and does not remove access to Regular scout mode.
The provided document is a 510(k) summary for the GE Revolution CT Family with the SmartScout option. It details the device's technical specifications, intended use, and a comparison to its predicate device. However, it explicitly states that no additional clinical testing was required for this submission.
Therefore, the document does not contain the information requested regarding acceptance criteria, performance data from a clinical study, sample sizes, expert ground truth establishment, or multi-reader multi-case studies, as these types of studies were not conducted for the justification of this specific modification (SmartScout).
The document notes: "The Revolution CT family with SmartScout can be fully tested on the engineering bench thus no additional clinical testing was required."
It emphasizes that "Qualitative and quantitative phantom studies demonstrate that the SmartScout delivers the similar CT Scout image quality at the similar size-appropriate dose levels (CTDIvol) compared to regular Scout scan." This indicates that the substantiation of performance was based on non-clinical phantom studies and engineering testing.
In summary, none of the requested information regarding clinical acceptance criteria or studies can be extracted from this document, as no such clinical studies were performed or reported for this 510(k) submission.
§ 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.