Device Dossier

X-ray tube housing assembly

Device Dossier for X-ray tube housing assembly (X-ray tube housing assembly, Class IIb, sponsor GE Healthcare). ARTG record, intended purpose, GMDN…

Intended purpose

This X-ray tube assembly is intended to provide shielding from X-radiation generated during patient examinations or treatments. The tube design integrate a thick steel frame: this envelop is intended to provide a grounded enclosure for the x-ray tube which prevents electrical arcs from the high-voltage components of the x-ray tube and cables to surrounding objects, e.g. the patient or operator. This device is intended to also reduce the level of X-radiation in the vicinity of the x-ray tube to acceptable levels.

TGA Public Summary