Device Dossier

Radiology picture archiving and communication system application software

Device Dossier for Radiology picture archiving and communication system application software (Radiology picture archiving and communication system…

Intended purpose

The device is a software application that displays medical image data and associated clinical reports. It performs operations relating to the transfer, storage, display, and measurement of image data. It allows users to perform image manipulations, including window/level, rotation, zoom, measurement, MIP/MPR/3D and markup. It displays both lossless and lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

TGA Public Summary