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 provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. The software can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. 3D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, and reporting tools are provided.

TGA Public Summary