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Indirect flat panel x-ray detector

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Indirect flat panel x-ray detector
Australia TGA ARTG Registered Device
Good Name: Fujifilm Australia Pty Ltd - Indirect flat panel x-ray detector
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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.

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
Manufacturer
Country
Japan
Address
26-30 Nishiazabu 2 Chome, MINATO KU TOKYO, 106 8620