Device Dossier

Workstation, picture archiving and communication system

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

Intended purpose

CubeVue serves as an accessory to Cone Beam CT extremity imaging devices with the intended use to retrieve, display, and distribute 2D and 3D volumetric image data. The image displaying component allows users to manipulate the images to aid in diagnosis and treatment planning, including rotating and navigating through 3D renderings and 2D MPR slices, adjusting display settings, and making measurements. It is the user's responsibility to ensure monitor quality and ambient light conditions are consistent with the clinical application.

TGA Public Summary