Device Dossier

Radiology DICOM image processing application software

Device Dossier for Radiology DICOM image processing application software (Radiology DICOM image processing application software, Class IIb, sponsor JY…

Intended purpose

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. The software displays by color the segmented lungs and identified lesions. ClariPulmo provides optional denoising and kernel normalization functions for an improved detection and quantification of lung lesions in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels.

TGA Public Summary