X-ray system, diagnostic, computed tomography, application program software - ARTG 311419
Access comprehensive regulatory information for X-ray system, diagnostic, computed tomography, application program software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 311419 and sponsored by GE Healthcare Australia Pty Ltd, manufactured by GE Medical Systems LLC in United States of America. The device registration started on November 12, 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 be used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR or PET studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric,interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.