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The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner to an output file. It is also intended as pre-operative software for surgical planning

The PROcedure Rehearsal Studio software allows clinicians to create a patient specific 3D anatomical model based on a patient's CT for the purpose of preoperative surgical planning. The 3D segmentation model produced by the PROcedure Rehearsal Studio may be exported to the Simbionix ANGIO Mentor Simulator Practice Environment and allow the physician to create a library of modules for training and post-operative debriefing. The ANGIO Mentor Simulator Practice Environment is not meant for clinical purposes and is intended to be used for training purposes only. The modifications subject to this Special 510(k) submission are: (1) Graphic User Interface changes in various locations; (2) functional change in various locations which enable the addition of a Neuro module that allows the software to create 3D models for neurological scans in addition to the thoracic (TEVAR), abdominal (EVAR) and Carotid options that were previously cleared. The Neuro module builds upon the previously cleared PROcedure Rehearsal Studio modules by adding the support for segmentation of the cerebral circulation system in addition to existing carotid, thoracic, and abdominal anatomies.