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The HealthCCSng device is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The HealthCCSng device analyzes routine non-gated, non-contrast CT studies that include the entire heart of adult patients of age 30-85. The device generates an exact calcium soore and a four coronary artery calcium detection category output representing the estimated quantity of calcium detected together with preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. A list of studies that received a successful algorithm analysis result will also be available for further clinician assessment (such as by a cardiologist, general practitioner etc.). The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies.

HealthCCSng product is a software device that automatically estimates the coronary artery calcium category from non-cardiac-gated adult CT scans. The product is aimed to leverage the high utilization of CT scans in the medical care environment (both inpatient and outpatient), including lung cancer screening programs, in order to automatically detect calcification in the coronary arteries of patients in an opportunistic manner. The HealthCCSng product analyzes cases using an artificial intelligence algorithm for the automated detection and estimation of coronary calcium and outputs a result for review by the clinician. The device works in parallel to and in conjunction with the standard of care workflow. The final diagnosis is made by the clinician after reviewing the scan independently of the software. The device is intended for use by the clinicians as a non-diagnostic analysis software in conjunction with additional patient information and professional judgment. HealthCCSng receives a non-gated, non-contrast CT study from the storage application, Nanox AI's Imaging Analytics Platform (IMA)/ other platforms. For each CT study received, the software shall validate at least one compliant series in which the entire heart is present and performs an analysis. For each complaint study, the software shall output: 1. Estimated Coronary Calcium Detection, based on the measurement of calcium deposits in the coronary arteries. 2. A corresponding Estimated Coronary Calcium Detection Category, based on the Estimated Coronary Calcium measurements. The software output will include the following calcium categories: Estimated Coronary Calcium Detection | Corresponding Estimated Coronary Calcium Detection Category -----------------------------------------|---------------------------------------------------------------- 0 | Zero Calcium 1-99 | Low 100-399 | Medium >= 400 | High For patients in which calcium was detected, the user will be presented with representative key images - all the slices containing the measured coronary calcifications (130 HU and above). On these images, the calcified areas will be annotated. The following modules compose the HealthCCSng software: 1) Data input and validation: DICOM validation receives imaging study from hosting application and the validation feature assessed the input data (i.e. age, modality, view, etc.) to ensure compatibility for processing by the algorithm. 2) HealthCCSng algorithm: Once a study has been validated, the algorithm analyzes the CT for analysis and quantification. 3) IMA Integration feature: The results of a successful study analysis are provided to the hosting application. 4) Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system. The product operates in the following manner: 1. A CT scan is sent to the Image Analytics Platform (IMA). 2. The Image Analytics Platform (IMA) forwards the scan to the HealthCCSng algorithm for analysis. 3. The scan is analyzed, with the following possible results sent back to IMA: a. Non-compliant: the scan is not compliant with the input criteria of the product and is therefore not analyzed. b. Success - 1. Success A Zero calcium, Low, Medium or High Coronary Calcium Detection has been identified. 2. Success No Category Cause: metal artifact(s) suggestive of known cardiac disease is suspected. c. Failure: the scan has been analyzed. An error prevented the device from completing the analysis and therefore there is no output available. In all cases of success. HealthCCSng will provide key images of visualization of the detected coronary calcium (except for zero category), the category name and the exact score.

The HealthFLD device is an image processing software that provides quantitative and qualitative analysis of the liver from CT images to support clinicians in the evaluation and assessment of Fatty Liver. The HealthFLD software provides measurements of liver attenuation (mean HU in a region of interest). HealthFLD is indicated for use in non-contrast and contrast CT scans, with any clinical indication, for patients aged 18 up to 75. CTs must include a significant part of the liver. The HealthFLD device is not intended to provide a diagnosis or risk assessment of fatty liver disease.

The HealthFLD device is an image processing software that provides quantitative and qualitative analysis of the liver from CT images to support clinicians in the evaluation and assessment of Fatty Liver. The HealthFLD software provides measurements of liver attenuation (mean HU in a region of interest) for any compatible CT scan that includes a significant part of the liver The Liver measurement display threshold is <40 HU for non-contrast/non portal venous phase CTs. When portal venous contrast phase is identified by the algorithm, the HealthFLD device automatically adjusts the display threshold to <75 HU. The following modules compose the HealthFLD software: - 1) Data input and validation: DICOM validation receives imaging study from hosting application and the validation feature assessed the input data (i.e. age, modality, view, etc.) to ensure compatibility for processing by the algorithm. - 2) HealthFLD algorithm: Once a study has been validated, the algorithm analyzes the CT for analysis and quantification. - 3) IMA Integration feature: The results of a successful study analysis is provided to the hosting application. - 4) Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system.