Device Dossier

Information system software, application program, radiology

Device Dossier for Information system software, application program, radiology (Information system software, application program, radiology, Class IIa,…

Intended purpose

The device is an application software program, routines, and algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network.

TGA Public Summary