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ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to support the quantification of lung CT images. The software is designed to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from the CT thoracic datasets. (The software is not intended for the diagnosis of pneumonia or COVID-19). The software provides automated segmentation of the lungs and quantification of low-attenuation and high-attenuation areas within the segmented lungs by using predefined Hounsfield unit thresholds. The software displays by color the segmented lungs and analysis results. ClariPulmo provides optional denoising and kernel normalization functions for improved quantification of lung CT images in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels.

ClariPulmo is a standalone software application analyzing lung CT images that can be used to support the physician in the quantification of lung CT image when examining pulmonary tissues. ClariPulmo provides two main and optional functions: LAA Analysis provides quantitative measurement of pulmonary tissue image with low attenuation areas (LAA). LAA are measured by counting those voxels with low attenuation values under the user-predefined thresholds within the segmented lungs. This feature supports the physician in quantifying lung tissue image with low attenuation area. HAA Analysis provides quantitative measurement of pulmonary tissue image with high attenuation areas (HAA). HAA are measured by counting those voxels with high attenuation values using the user-predefined thresholds within the segmented lungs. This feature supports the physician in quantifying lung tissue image with high attenuation area. Lungs are automatically segmented using a pre-trained deep learning model. The optional Kernel Normalization function provides an image-to-image translation from a sharp kernel image to a smooth kernel image for improved quantification of lung CT images. The Kernel Normalization algorithm was constructed based on the U-Net architecture. The optional Denoising function provides an image-to-image translation from a noisy low-dose image to a noise-reduced enhanced quality image of LDCT for improved quantification of lung LDCT images. The Denoising algorithm was constructed based on the U-Net architecture. The ClariPulmo software provides summary reports for measurement results that contains color overlay images for the lungs tissues as well as table and charts displaying analysis results.

ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM uses this numerical value to provide breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) to aid interpreting physicians in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not a diagnostic aid.

ClariSIGMAM software is a standalone software application that automatically analyzes "for presentation" 2D digital mammograms to assess breast tissue composition. The software assesses the breast density of women and generates a breast density group information for the patient (BI-RADS A+B as fatty and BI-RADS C+D as dense) in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) density classification scale. Output of breast density by ClariSIGMAM is designed to display on a mammography workstation or PACS as DIOCM mammography structured report or secondary capture. The reports are configured to provide the following data: Breast area (cm²) for each breast, Fibroglandular tissue area (cm²) for each breast, Percent breast density for each breast, Breast density group information for the patient (BI-RADS A+B as fatty and BI-RADS C+D as dense).

ClariCT.AI is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.

ClariCT.AI software is intended for denoise processing and enhancement of CT DICOM images when higher image quality and/or lower dose acquisitions are desired. ClariCT.Al software can be used to reduce noises in CT images of the head, chest, and abdomen, in particular in CT images with a lower radiation dose. ClariCT.Al may also improve the image quality of low-dose nondiagnostic Filtered Back Projection images as well as Iterative Reconstruction images. The subject device, ClariCT.Al, added a new module (named Al Marketplace Integration module) to the original cleared device (K183460) to enable installation on the Al Marketplace system. The module integrates the Denoising Processor of the original device into the Al Marketplace system. So ClariCT.Al can be hosted through a third-party Al marketplace that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure.

ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.

ClariCT.Al software is intended for denoise processing and enhancement of CT DICOM images when higher image quality and/or lower dose acquisitions are desired. ClariCT.Al software can be used to reduce noises in CT images of the head, chest, heart, and abdomen, in particular in CT images with a lower radiation dose. ClariCT.Al may also improve the image quality of low-dose nondiagnostic Filtered Back Projection images as well as Iterative Reconstruction images. The system enables the receipt of DICOM images from CT imaging devices (modalities), enables their denoise processing and enhancement, and transmission to a PACS workstation.