X-ray system, diagnostic, computed tomography, application program software - ARTG 483165
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 483165 and sponsored by KD & A Pty Ltd, manufactured by Circle Cardiovascular Imaging Inc in Canada. The device registration started on March 19, 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.
StrokeSENS is a decision-aid software package to be used by clinicians to perform image processing, analysis, viewing and communication of computed tomography (CT) scans of the brain in patients with suspected acute stroke. Data and images are acquired through DICOM-compliant imaging devices prior to processing and analysis in StrokeSENS. The StrokeSENS software provides analysis capabilities for imaging datasets acquired with standard CT imaging and contrast-enhanced CT Angiography (CTA) modalities. Analysis of non-contrast CT images is provided by the StrokeSENS ASPECTS module, which includes assessment of regions with suspected acute ischemic tissue (ie. ASPECTS scoring). Analysis of contrast-enhanced CT images is provided by the StrokeSENS LVO module, which includes automated detection of suspected large vessel occlusion (LVO).