Device Dossier

Indirect flat panel x-ray detector

Device Dossier for Indirect flat panel x-ray detector (Indirect flat panel x-ray detector, Class IIa, sponsor Regional Health Care Group). ARTG record,…

Intended purpose

The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes. When the dual energy subtraction function is enabled, it is intended to assist the physician through the visualisation of anomalies by reducing the visibility of underlying or overlying anatomical structures. This device is not intended for use in mammography applications.

TGA Public Summary