Search Results

The Siemens syngo Volume Perfusion-CT Body software package 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 package 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.

A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

syngo® Volume Perfusion-CT Body is a post-processing software package, which runs on an Intel-based PC platform designed to post-process images acquired with SOMATOM CT scanners, which meet certain minimal requirements (i.e. Siemens Definition, Sensation 64, ... ). It is a package containing evaluation software that supports the evaluation of Dynamic CT data gathered after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer.

The Siemens syngo Volume Perfusion-CT Body software package 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 package 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.

A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

The provided document is a 510(k) summary for the Siemens syngo® Volume Perfusion-CT Body software. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's intended use and general safety concerns.

Crucially, the provided text does not include information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in detailed performance studies. The document describes the device, its intended use, and states that "verification and validation testing" are used to control potential hazards, but it does not present the results of such testing or outline the acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information directly from this document.

The document mainly serves as a regulatory submission demonstrating substantial equivalence to pre-existing similar devices based on their functional purpose (evaluating perfusion from CT data) rather than a detailed performance study with quantifiable acceptance criteria.

Ask a specific question about this device