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

TomTec-Arena software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TomTec-Arena is not intended to be used for reading of mammography images. Indications for use of TomTec-Arena software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.

TGA Public Summary