Device Dossier

X-ray image interpretive software

Device Dossier for X-ray image interpretive software (X-ray image interpretive software, Class IIa, sponsor 4D Medical). ARTG record, intended purpose,…

Intended purpose

The Software uses CT density values of pulmonary tissue to provide quantitation and visualization in support of diagnosis. The software performs three-dimensional segmentation and classifies the lung voxels into typical radiological categories. Automated reports and color overlays of the analysis are provided to support diagnosis when abnormal lung parenchymal densities are present.

TGA Public Summary