ARTG 480824Radiology picture archiving and communication system application software
ARTG ID: 480824 · Evolution Surgical Pty Ltd · SMAIO · Class IIa · Started February 25, 2025
Good Name: Evolution Surgical Pty Ltd - Radiology picture archiving and communication system application software
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 480824
- Start Date
- February 25, 2025
- Effective Date
- February 25, 2025
- Name
- SMAIO
- Country
- France
- Address
- 2 Place Berthe Morisot, Parc Technologique, SAINT PRIEST, 69800
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.
Access comprehensive regulatory information for Radiology picture archiving and communication system application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 480824 and sponsored by Evolution Surgical Pty Ltd, manufactured by SMAIO in France. The device registration started on February 25, 2025.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.