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Posterior eye segment analysis system application software - ARTG 351910

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 registered under ARTG number 351910 and 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.

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Class Im
ARTG 351910
Class Im
Posterior eye segment analysis system application software
ARTG ID: 351910
Good Name: Optimed Pty Ltd- Posterior eye segment analysis system application software
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Intended Purpose

Ophthalmic Software Platform RX is a software to manage the patientโ€™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

Device Classification
Risk Class
Class Im
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
351910
Start Date
December 18, 2020
Effective Date
December 18, 2020
Sponsor
Manufacturer
Country
Japan
Address
9-1 Imaikami-cho Nakahara-Ku, Kawasaki, Kanagawa, 211-8501