ClariPulmo

Primary DI

D-88000468PMO-20GUNQ

Basic UDI-DI Code

B-88000468PMO-20GUNQ

Reference

ClariPulmo

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

ClariPi Inc.

ClariPulmo is a non-invasive image analysis software for use with CT images, which is intended to aid the assessment of lung lesions (e.g., emphysema, pneumonia, nodules, etc.). The software is designed to support the physician in confirming the presence or absence as well as quantification of physician-identified lung lesions. 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 will also provide automated detection, segmentation, and quantification of lung nodules in screening examinations, as well as nodule tracking and calculation of nodule malignancy according to a predefined formula which is clinically accepted and publicly available. The software displays by color the segmented lungs and identified lesions. ClariPulmo provides optional denoising and kernel normalization functions for improved detection and quantification of lung lesions 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.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).