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

The KEOPS Balance Analyzer 3D is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. KEOPS Balance Analyzer 3D (KBA3D) is a decision support system for people with appropriate medical training and should not be used as the sole basis for making clinical decisions relating to patient diagnosis, treatment or care.

TGA Public Summary