Device Dossier

Diagnostic x-ray digital imaging conversion system

Device Dossier for Diagnostic x-ray digital imaging conversion system (Diagnostic x-ray digital imaging conversion system, Class IIa, sponsor Fujifilm).…

Intended purpose

The flat panel sensor system is intended for healthcare professionals to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The device is not intended for mammography, fluoroscopy, tomography and angiography applications.

TGA Public Summary