(51 days)
QAngio CT software solution has been developed for the objective and reproducible analysis of vessels in CTA images. It enables the quantitative analysis of CT angiograms based on automated segmentation. More specifically, QAngio CT can be used to quantify a number of lesion characteristics. QAngio CT is intended for use as an auxiliary tool in assessing CTA studies in clinical practice and in clinical trials. The analysis results obtained with QAngio CT are to be interpreted by cardiologists and radiologists.
QAngio CT is able to read DICOM CT images from all major CT scanner vendors. Vessel analysis data, generated by automated (and/or manual) segmentation, detected stenosis, and quantitative results, can be saved in separate files enabling the comparison of results from different users. Radiologists, cardiologists and technicians use the QAngio CT analytical software package to obtain objective and reproducible results. The obtained results may be used to support the interpretation of CTA data, or they are used in the evaluation of follow-up studies and the effectiveness of treatment. In clinical practice the QAngio CT software is used on workstations in review rooms or integrated in a PACS environment.
The provided text does not contain information regarding the acceptance criteria, specific study details (sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, or standalone performance), or the type of ground truth used.
The document is a 510(k) summary for a medical device called QAngio CT, which is a software for the quantitative analysis of CT angiograms. It describes the device's intended use and claims substantial equivalence to a predicate device. It also includes the FDA's clearance letter.
Therefore, I cannot provide the requested table and study details 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.