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FDA-cleared K212758

Autoplaque

Cedars-Sinai Medical Center: AIM

Authorized purpose: Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Autoplaque is a workstation-based post processing application. It is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present. Autoplaque must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2023-05-19