Device Dossier

Workstation, picture archiving and communication system

Device Dossier for Workstation, picture archiving and communication system (Workstation, picture archiving and communication system, Class IIb, sponsor…

Intended purpose

The device is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists. It is a software application intended to display and visualize 2D & 3D multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include CT, PET, MR, SPECT and planar NM. Supported image types include static, gated and dynamic. The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets. The device allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison of image data by the user. The result of the registration operation can assist the user in assessing changes in image data, either within or between examinations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly. It provides a number of tools such as rulers and region of interests intended to be used for the assessment of regions of an image to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of lesions, determination of treatment response and follow-up. The device allows the user to define, import, transform, store and export regions of interest structures in DICOM RT format for use in radiation therapy planning systems.

TGA Public Summary