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Ultrasound system, imaging, general-purpose - ARTG 460927

Access comprehensive regulatory information for Ultrasound system, imaging, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 460927 and sponsored by Fujifilm Australia Pty Ltd, manufactured by Fujifilm Corporation in Japan. The device registration started on August 27, 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
ARTG 460927
Class IIa
Ultrasound system, imaging, general-purpose
ARTG ID: 460927
Good Name: Fujifilm Australia Pty Ltd - Ultrasound system, imaging, general-purpose
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Intended Purpose

The subject Ultrasound imaging systems are intended for performing tomography and hemodynamic diagnosis of blood flow in the human body. The subject systems are intended to be used by doctors and other qualified health care professionals only.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
460927
Start Date
August 27, 2024
Effective Date
August 27, 2024
Manufacturer
Country
Japan
Address
26-30 Nishiazabu 2 Chome, MINATO KU TOKYO, 106 8620