Device Dossier

MRI system, application program software

Device Dossier for MRI system, application program software (MRI system, application program software, Class IIa, sponsor Philips Electronics). ARTG…

Intended purpose

DynaCAD is a MR image analysis software medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: • MR Analysis Server post-processing software application facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. • Viewer application facilitates the analysis and presentation of datasets generated by the MR Analysis Server. Interventional Planning image-guidance application for diagnostic and interventional procedure planning for biopsy and/or soft tissue ablation [DynaCAD Ablation Planning is not available for markets within the European Union & Australia/New Zealand]. DynaCAD is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland or breast tissue

TGA Public Summary