ClariPulmo
ClariPi Inc.
ClariPi Inc.
PMN#
GUDID#
ClariPulmo - ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to aid the assessment of lung Abnormalities. The software is designed to support the physician in quantification of physician identified lung Abnormalities. The software will provide 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 identified Abnormality. ClariPulmo provides optional denoising and kernel normalization functions for improved quantification of lung Abnormalities in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels.ClariPulmo also includes functionality for automated segmentation and quantification of organs included in the input CT images. Furthermore, it enables presentation of the quantified values in user-defined unit by using predefined HU thresholds and conversion table.
2025-06-25
ClariPlatform - ClariPlatform (Ver. 1.0) is a medical imaging platform that hosts clinical AI solutions in a cloud-based SaaS format.The system facilitates the networking, filtering, routing, and de-identification of medical image data between imaging systems, allowing users to easily execute AI solutions on-demand or integrate them into their clinical workflow.ClariPlatform is only deployed on the cloud, ensuring accessibility and compliance with regulations.Clinical AI solutions refer to separate medical device software and are not included within the scope of this system.
2025-03-10
ClariPlatform - ClariPlatform (Ver. ClariSuite View) is a medical imaging platform that hosts clinical AI solutions and provides user interface in an on-premise environment. The system facilitates the networking, filtering, routing, and optional de-identification of medical image data between imaging systems, allowing users to easily execute AI solutions on-demand or integrate them into their clinical workflow. Additionally the system allows users to interact with the AI analysis results including confirming, rejecting, and selecting other category than provided by AI. While ClariPlatform (Ver.1.0) operates as a cloud-based system, ClariPlatform (Ver. ClariSuite View) is specifically designed for on-premise deployment, ensuring compliance with institutional security policies, regulatory requirements, and data privacy concerns. ClariPlatform (Ver. ClariSuite View) is deployed within anorganization’s internal infrastructure, allowing healthcare providers to maintain full control over medical imaging data while leveraging advanced AI-assisted visualization tools.Clinical AI solutions refer to separate medical device software and are not included within the scope of this system.
2025-03-10
ClariCT.AI - 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. The original cleared device (K183460) is a software application to denoise on CT images, integrated with the clinical environment through DICOM communication on an on-premise environment, and runs under Microsoft Windows platform. The device consists of Denoise Processing module that denoises CT images and other modules (Window application module) that provide many features such as handling DICOM connection from/to PACS, user interface, worklist management and viewer. The subject device, ClariCT.AI, has 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 original device into the Al Marketplace system and includes an optional multiframe PET-CT module which denoises multiframe PET-CT fusion images included as a series in CT study. ClariCT.AI, consists only of the Al Marketplace Integration Module and the Denoising Processor, can be installed in the Al Marketplace system that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure. An Al Marketplace system, which can be integrated with the ClariCT.AI, is a cloud-based Al platform service that connects end users (e.g. hospitals, imaging centers) and Al medical imaging applications developed by third parties. These Al Marketplace systems provide many features such as handling DICOM connection from/to PACS, user interface, authentication, worklist control, and orchestrating third party Al applications. With the newly added module, ClariCT.Al will function as a software device integrated with such system, and therefore the responsibility of our software is bound to change so as to take care of only essential functionality such as denoising process and system interface.
2024-11-29
ClariCT.AI - 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. The original cleared device (K183460) is a software application to denoise on CT images, integrated with the clinical environment through DICOM communication on an on-premise environment, and runs under Microsoft Windows platform. The device consists of Denoise Processing module that denoises CT images and other modules (Window application module) that provide many features such as handling DICOM connection from/to PACS, user interface, worklist management and viewer. The subject device, ClariCT.AI, has 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 original device into the Al Marketplace system and includes an optional ACE module that additionally improves the CNR of CECT (Contrast-Enhanced CT) images.ClariCT.AI, consists only of the Al Marketplace Integration Module and the Denoising Processor, can be installed in the Al Marketplace system that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure. An Al Marketplace system, which can be integrated with the ClariCT.AI, is a cloud-based Al platform service that connects end users (e.g. hospitals, imaging centers) and Al medical imaging applications developed by third parties. These Al Marketplace systems provide many features such as handling DICOM connection from/to PACS, user interface, authentication, worklist control, and orchestrating third party Al applications. With the newly added module, ClariCT.Al will function as a software device integrated with such system, and therefore the responsibility of our software is bound to change so as to take care of only essential functionality such as denoising process and system interfa
2024-11-27
ClariCT.AI - 1.1.0
2019-12-20
ClariSIGMAM - 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 provides these numerical values along with breast density category in BI-RADS 5th Edition to aid radiologists in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not an interpretive or diagnostic aid.
2023-08-31
ClariPulmo - ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to aid the assessment of lung Abnormalities. The software is designed to support the physician in quantification of physicianidentified lung Abnormalities. The software will provide 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 identified Abnormality. ClariPulmo provides optional denoising and kernel normalization functions for improved quantification of lung Abnormalities in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels.
2023-08-31
ClariCT.AI - 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.The original cleared device (K183460) is a software application to denoise on CT images, integrated with the clinical environment through DICOM communication on an on-premise environment, and runs under Microsoft Windows platform. The device consists of Denoise Processing module that denoises CT images and other modules (Window application module) that provide many features such as handling DICOM connection from/to PACS, user interface, worklist management and viewer. The subject device, ClariCT.AI, added a new module (named AI Marketplace Integration module) to the original cleared device (K183460) to enable installation on the AI Marketplace system. The module integrates the Denoising Processor of original device into the AI Marketplace system. ClariCT.AI, consists only of the AI Marketplace Integration Module and the Denoising Processor, can be installed in the AI Marketplace system that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure.An AI Marketplace system, which can be integrated with the ClariCT.AI, is a cloud-based AI platform service that connects end users (e.g. hospitals, imaging centers) and AI medical imaging applications developed by third parties. These AI Marketplace systems provide many features such as handling DICOM connection from/to PACS, user interface, authentication, worklist control, and orchestrating third party AI applications. With the newly added module, ClariCT.AI will function as a software device integrated with such system, and therefore the responsibility of our software is bound to change so as to take care of only essential functionality such as denoising process and system interface.
2023-08-29