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

The NeuViz ACE 128 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating Xray tube and detector array. The acquired XRAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. It is used to scan the patient (neonate, child and adult) and perform post image processing for diagnoses of the patient.

TGA Public Summary