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 housing assembly is intended to provide shielding from x-radiation generated during patient examinations or treatments. This housing assembly is intended to provide a grounded, oil filled 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