X-ray image interpretive software - ARTG 337312
Access comprehensive regulatory information for X-ray image interpretive software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 337312 and sponsored by GE Healthcare Australia Pty Ltd, manufactured by GE Medical Systems LLC in United States of America. The device registration started on June 01, 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.
This device is intended as a computer aided triage and diagnosis device that analyzes frontal chest x-ray images acquired on a digital x-ray system for the presence of prespecified critical findings (e.g. pneumothorax). The device produces an on-screen notification and an image flag to enable case prioritization. Critical Care Suite provides adjunct information to aid with the prioritization and diagnosis of critical findings. Intended users includes technologist, clinical care team, and radiologist.It is intended for notification only and does not provide diagnostic information beyond the notification. This device should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. This device is not intended to replace the review of the x-ray image by a qualified physician. This device is indicated for adult-size patients.