Device Dossier

Computed radiographic system

Device Dossier for Computed radiographic system (Computed radiographic system, Class IIa, sponsor Fujifilm). ARTG record, intended purpose, GMDN category…

Intended purpose

A Workstation console used in conjunction with a Fuji Computed Radiography System (a cassette containing a imaging plate and an image reader) and conventional mammography radiographic X-Ray system. The image is acquired on a photostimulatable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner; this signal is in turn amplified and converted to a digital signal, which is stored and processed by the Fujifilm Mammoascent AWS-c Console/Workstation.

TGA Public Summary