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ClearRead CT CAC is image processing software designed to aid physicians in assessing coronary artery calcification on non-gated, non-contrast, standard, or low-dose chest CT scans of adult patients 30 years of age or older. The primary output of ClearRead CT CAC is the Agatston score. ClearRead CT CAC locates calcified coronary lesions and assigns them to one of several coronary arteries: the right coronary artery (RCA), the left main artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (LCX). The software calculates the Agatston score as the sum for each artery while also providing the total across all coronary arteries. The total Agatston score is calibrated to 3.0mm slice thickness and is used to derive a CAC category and the arterial age. The provided segmentations are for illustrative purposes only and are not intended for diagnostic use. ClearRead CT CAC provides adjunctive information and is not intended to be used without clinical expert review.

ClearRead CT CAC is a computer aided quantification system intended to aid in the assessment of coronary artery calcification. The system receives chest Computed Tomography (CT) studies as input, in DICOM® format, and generates output in DICOM (or other) format.

ClearRead CT is comprised of computer-assisted reading tools designed to aid the radiologist in the detection and characterization of pulmonary nodules during the review of screening and surveillance (low-dose) CT examinations of the chest on a non-oncological patient population. ClearRead CT requires both lungs be in the field of view and is not intended for monitoring patients undergoing therapy for lung cancer or limited field of view CT scans. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.

ClearRead CT Compare is a post-processing application which processes a prior chest CT to determine whether a nodule detected in the current exam was present in the prior exam using the same detection algorithm used on the current exam. ClearRead CT Compare requires both lungs to be in the field of view. ClearRead CT Compare provides adjunctive information and is not intended to be used without the original CT series and is only invoked on those patients where a prior exam exists and if a nodule is detected in the current exam. ClearRead CT Compare receives images according to the DICOM® protocol, processes the Lung CT series, and delivers the resulting information through the same DICOM network interface in conjunction with results provided for the current exam, specifically whether the nodule is present on the prior exam and if so, the percent volume change between the current and prior exam along with the volume doubling time. Series inputs are limited to Computed Tomography (CT). The ClearRead CT Compare Processor processes each prior series received. The ClearRead CT Compare output is sent to a destination device that conforms to the ClearRead CT DICOM Conformance Statement, such as a storage archive. ClearRead CT Compare does not support printing or DICOM media. ClearRead CT Compare is a product extension of our FDA cleared and marketed ClearRead CT device (K161201). The initial device contained ClearRead CT Vessel Suppress as well as ClearRead CT Detect. ClearRead CT (the base system), includes normalization, segmentation, and characterization of nodules, and provides the following key features: ● ClearRead CT Vessel Suppress aids radiologists by suppressing normal structures in the input chest CT series. . ClearRead CT Detect aids radiologists in the detection and characterizations of nodules in the input chest CT series. ● ClearRead CT Compare includes Scan Registration and Nodule Matching functions and adds the following key features: ClearRead CT Compare aids radiologists in ● tracking nodule changes over time, providing additional characterizations per nodule, including percent nodule change and volume doubling time.

ClearRead Xray Pneumothorax is a notification-only triage workflow tool for use by trained professionals to help prioritize chest X-rays. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of a pneumothorax 5 mm or larger; it makes case-level output available to a PACS/workstation for worklist prioritization or triage. Identification of cases suspected of containing a pneumothorax is not for diagnostic use beyond notification. ClearRead Xray Pneumothorax is limited to analysis of imaging data as a guide to possible urgency of adult chest X-ray image review and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnoses. The device does not replace review and diagnosis of the Xrays by trained professionals. The device is not intended to be used with plain film X-ray.

ClearRead Xray Pneumothorax is comprised of a computer assisted triaging tool, designed to prioritize chest X-rays based on the suspected presence of a pneumothorax (PTX) 5mm or larger. ClearRead Xray Pneumothorax requires both lungs to be in the field of view. ClearRead Xray Pneumothorax provides adjunctive information and is not intended to be used for diagnosis. ClearRead Xray Pneumothorax receives images according to the DICOM® protocol (via a standard IEEE 802.3 network connection), processes the image, and delivers the resulting information through the same DICOM network interface. Image inputs are limited to adult, digital frontal chest radiographs. The output results are sent to facilitate prioritization of chest Xrays for radiologist review on one or more devices that conform to the ClearRead Xray Pneumothorax DICOM Conformance Statement. ClearRead Xray Pneumothorax does not support printing or DICOM media.