Analyser software, application program
Access comprehensive regulatory information for Analyser software, application program in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Intervene Medical Pty Ltd, manufactured by Medis Medical Imaging System bv in Netherlands. The device registration started on November 29, 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.
Medis Suite XAIV is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by Medis Suite XAIV are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.