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510(k) Data Aggregation
K Number
K212758Device Name
Autoplaque
Manufacturer
Cedars-Sinai Medical Center: AIM
Date Cleared
2023-05-19
(626 days)
Product Code
LLZ, QIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Cedars-Sinai Medical Center: AIM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
Autoplaque 3.0. a stand-alone software, performs post-processing of coronary Computed Tomography Angiography (CTA) images and measurements of components of images using computerized algorithms.
Autoplaque 3.0 aids the physician with measurement of coronary artery stenosis and provides measurements for coronary plaque and coronary artery remodeling. Autoplaque 3.0 does not replace standard clinical practice or clinician decision making.
Autoplaque 3.0 allows for standardized characterization of plaque and stenosis from DICOM image data (loaded from the local computer hard drive) and includes the following features:
- Review of heart and coronary vessels in Multiplanar Reformatting (MPR), curved MPR, and straightened MPR views:
- Measurement of vessel diameter and area;
- Characterization and measurement of plaque parameters; and
- Measurement of lumen diameter, area, and luminal stenosis.
Autoplaque 3.0 includes automated vessel, plaque and lumen segmentation, which is reviewed and can be edited, if necessary, by the clinician.
Autoplaque 3.0 can run on Windows or Mac computer platforms. The minimum hardware specifications are specified in the user manual.
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