Device Dossier

Indirect flat panel x-ray detector

Device Dossier for Indirect flat panel x-ray detector (Indirect flat panel x-ray detector, Class IIb, sponsor Shimadzu). ARTG record, intended purpose,…

Intended purpose

The flat panel detector is a digital X-ray imaging solution that captures X-rays transmitted through the human body and acquires images by wired or wireless connection. The detector digitalizes X-ray images and transfers them to the PC (workstation) for diagnostic review using an image display monitor. This detector is used for the general-purpose diagnostic procedures, and it is intended to replace radiographic film / screen systems. It is not intended for mammography applications.

TGA Public Summary