(71 days)
The CT Coronary Artery Calcification Scoring Option for Advantage Windows is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis. It runs on Advantage Windows independent workstations (K913770).
A software productivity package that semi-automatically quantified cardiac calcifications by a weighted number instead of manually calculating area of Regions of Interest (ROIs) and the density within each ROI.
The provided text is a K982004 510(k) summary for the GE Medical Systems' CT Coronary Artery Calcification Scoring Option for Advantage Windows. It outlines the device's purpose and its substantial equivalence to a predicate device but does not contain information about specific acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and basic device description rather than performance metrics or a detailed study report.
§ 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.