(7 days)
The Body Perfusion System software package is a noninvasive post-processing package that has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media. The software also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves.
When used by a qualified physician a potential application is to differentiate blood flow between normal and diseased tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.
It should be used by a trained and qualified physician.
The CSBP-001A is a noninvasive post-processing software that runs on a PC based console of the host CT device. It has been designed to assess dynamic (time lapsed collections) CT volume scans and provide data related to the volume sets.
This document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The provided text is a 510(k) summary for the Toshiba America Medical Systems, Inc. Body Organ Perfusion System, CSBP-001A. It outlines the device description, intended use, safety and effectiveness concerns, and states substantial equivalence to predicate devices, but lacks details about specific performance metrics or clinical study results.
Therefore, I cannot populate the table or answer the questions provided in the prompt based on the given input.
§ 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.