Device Dossier

X-ray system, diagnostic, computed tomography, full-body

Device Dossier for X-ray system, diagnostic, computed tomography, full-body (X-ray system, diagnostic, computed tomography, full-body, Class IIb, sponsor…

Intended purpose

This Computed Tomography X-Ray system is intended for head, body, cardiac and vascular X-ray Computed Tomography applications. The CardioGraphe Computed Tomography X-ray is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial, Cine, Cardiac and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

TGA Public Summary