Australia flagARTG 481926

Diagnostic digital imaging system workstation application software

ARTG ID: 481926 · GE Healthcare Australia Pty Ltd · GE Medical Systems LLC · Class I · Started March 06, 2025

Good Name: GE Healthcare Australia Pty Ltd - Diagnostic digital imaging system workstation application software

Device classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
481926
Start Date
March 06, 2025
Effective Date
March 06, 2025
Sponsor
Manufacturer
Country
United States of America
Address
3000 North Grandview Boulevard, Waukesha, WI, 53188
Intended purpose

A software quality tool that analyses x-ray images for the presence of prespecified errors within image acquisitions such as mismatched protocols, rotated images, and incomplete field of view. The software identifies images with quality issues and flags them for technologist review and/or automatically correct them. It is intended for notification and/or workflow improvement for quality control of acquired images and does not provide any diagnostic information.

About this record

Access comprehensive regulatory information for Diagnostic digital imaging system workstation application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 481926 and sponsored by GE Healthcare Australia Pty Ltd, manufactured by GE Medical Systems LLC in United States of America. The device registration started on March 06, 2025.

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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