Australia TGA ARTG record

Indirect flat panel x-ray detector

Australia TGA ARTG Registered Device · Fujifilm Australia Pty Ltd · Fujifilm Corporation · Class IIa · Started May 24, 2024

Good Name: Fujifilm Australia Pty Ltd - Indirect flat panel x-ray detector

Device classification

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

Registration information

Start Date: May 24, 2024
Effective Date: May 24, 2024

Sponsor

Name: Fujifilm Australia Pty Ltd

Manufacturer

Name: Fujifilm Corporation
Country: Japan
Address: 26-30 Nishiazabu 2 Chome, MINATO KU TOKYO, 106 8620

Intended purpose

The Flat panel sensor is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat panel sensor is not intended for mammography, fluoroscopy, tomography and angiography applications. However, among the flat panel sensors, DR-ID 1811SE, DR-ID 1812SE, and DR-ID 1814SE can also generate a fluoroscopic image when used with DR-XD 3000.

About this record

Access comprehensive regulatory information for Indirect flat panel x-ray detector in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Fujifilm Australia Pty Ltd, manufactured by Fujifilm Corporation in Japan. The device registration started on May 24, 2024.

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.