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,…
- GMDN category: X-ray image interpretive software
Intended purpose
The device is an interpretive software program intended to analyse chest x-ray or CT images to identify anatomical structures and provide quantitative measurements, such as the right-to-left ventricular (RV/LV) diameter ratio. It is compatible with standard medical imaging formats (e.g. DICOM) and is intended to suport, not replace, clinical judgement.