Device Dossier

Computed radiographic system

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

Intended purpose

Digital Imaging System, Computed Radiography General Purpose: The CR Console is a workstation that allows patient registration, identification, study QA and study delivery to DICOM compatible devices such as PACS and or printers. An assembly of devices that acquires and digitizes x-ray images for viewing, storage or hard copy printing. It is used in conjunction with conventional radiographic table systems for a variety of purposes. It typically consists of an exposure unit with image receptor (e.g. a cassette containing a plate), an image reader, a computer console and a printer. 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 a computer.

TGA Public Summary