Search Results

uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).

uCT 780 is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.

• Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.

The Computed Tomography X-ray system, uCT 780, is intended to produce cross-sectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast.

This 510(k) is to request modifications for the cleared Computed Tomography X-ray system uCT 780. uCT 780 has been previously cleared by FDA via K241079.The modification performed on the uCT 780 (K241079) in this submission is due to the addition of a new high voltage generator. At the same time, we introduce a mobile configuration which supports installation in vehicles. A summary of the modified hardware is provided below:

• A new model of high voltage generator uXG 100 has been introduced in the mobile configuration, and the predicate model CT140N80X4889 is still used in other non-mobile configurations.
• A tilt lock has been introduced to the gantry and a horizontal movement lock has been introduced to the standard config patient table, and the system software has been updated to include the relevant controls and prompts.
• PSC has been modified, including adding a shock-absorbing base, strengthening the sheet metal structure, and optimizing the fixing method of PSC.

N/A

Ask a specific question about this device