Australia TGA ARTG record

Posterior eye segment analysis system application software

Australia TGA ARTG Registered Device · Optimed Pty Ltd · Canon Inc · Class Im · Started December 18, 2020

Good Name: Optimed Pty Ltd- Posterior eye segment analysis system application software

Device classification

Risk Class: Class Im
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 18, 2020
Effective Date: December 18, 2020

Sponsor

Name: Optimed Pty Ltd

Manufacturer

Name: Canon Inc
Country: Japan
Address: 9-1 Imaikami-cho Nakahara-Ku, Kawasaki, Kanagawa, 211-8501

Intended purpose

Ophthalmic Software Platform RX is a software to manage the patient’s data and study information captured by Canon OCT(Optical Coherence Tomography) and Canon retinal camera and displays the images. It is capable of network configuration consists of Capture, Server and Viewer software

About this record

Access comprehensive regulatory information for Posterior eye segment analysis system application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is sponsored by Optimed Pty Ltd, manufactured by Canon Inc in Japan. The device registration started on December 18, 2020.

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.