(18 days)
QCA-CMS provides quantitative and reproducible information regarding the calculated dimensions of arterial segments imaged during angiographic x-ray procedures typically performed in cardiac cath labs. This information is suitable for use by physicians and scientists in the following applications:
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Scientific and research studies, assessing the angiographic condition of patients and the results of device and drug therapies,
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Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.
QCA-CMS performs quantitative analysis of angiograms that are input to the system in formats that include digitized video (from 35 mm cinefilm) and DICOM-file standard formats. The analysis results of the QCA-CMS operation may be printed or archived in files for export to a general-purpose database.
The provided document does not contain an acceptance criteria table, a study that proves the device meets specific acceptance criteria, or information regarding the device's performance metrics (e.g., accuracy, sensitivity, specificity).
The document is a 510(k) summary for a software device called QCA-CMS, which performs quantitative analysis of coronary angiograms. It focuses on demonstrating substantial equivalence to a predicate device (Cardiovascular Measurement System - CMS) and describes the intended use and technological characteristics.
Therefore, I cannot provide the requested information based on the input document.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.