MRI system, application program software - ARTG 305109
Access comprehensive regulatory information for MRI system, application program software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 305109 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 25, 2018.
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 to facilitate vascular reporting and the capability to generate reports with schematics and images for MR and CT vascular studies for the referring physician. It is available on the Advantage Workstations operating with version 4.2P or higher. This device can import medical images from a medical imaging device and display them in a viewing area on the workstation screen. It provides user customized tools to perform reporting on a medical images for MR and CT. Available tools include the selection of vascular schematics to aid in the reporting process. The results of the reporting application are interpreted by the physician and can be communicated to referring physicians. Only GE MR images are supported for analysis.