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iCAC is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above during routine care. The device automatically analyzes non-contrast chest computed tomography (CT) images collected during routine care and outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only) and both exact and four-category quantitative estimates of the patient's coronary artery calcium burden in Agatston units. The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device-generated calcium score or score group can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium segmentation in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original chest CT scan: both are still available to be viewed and used at the discretion of the physician. The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results.

The iCAC Device (or the "subject device") is a standalone software as a medical device (SaMD) that provides adjunctive information to a radiologist for an estimate assessment of the presence and quantity of coronary artery calcium (CAC) from routine, non-contrast, non-gated chest computed tomography (CT) scans. The device can be used to leverage the high utilization of non-gated chest CT scans (from lung cancer screening programs, routine exams, etc.) to opportunistically identify and quantify coronary artery calcium in patients. The iCAC Device takes as an input non-contrast, non-gated chest CT scans via DICOM transfer from the clinicians imaging database such as PACS or DICOM router. The device uses a deeplearning-based computer vision algorithm for its assessment. It estimates the presence and quantity of coronary artery calcium (CAC) from routine, non-contrast, non-gated chest computed tomography (CT) scans. iCAC Device can be used to leverage the high utilization of non-gated chest CT scans (from lung cancer screening programs, routine exams, etc.) to opportunistically identify and quantify coronary artery calcium in patients.