Device Dossier
Computed radiographic system
Device Dossier for Computed radiographic system (Computed radiographic system, Class IIb, sponsor Fujifilm). ARTG record, intended purpose, GMDN category…
- GMDN category: Computed radiographic system
Intended purpose
The flat panel detector system is intended 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 is not intended for mammography, fluoroscopy, tomography, and angiography applications.