Device Dossier

Radiology picture archiving and communication system application software

Device Dossier for Radiology picture archiving and communication system application software (Radiology picture archiving and communication system…

Intended purpose

Modus Plan’s indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion and image segmentation, where the output can be used for image guided surgery. Example procedures include but are not limited to: 1. Planning and simulation of cranial surgical procedures such as: a. lesionectomies or lesionotomies of epileptogenic foci b. resection of lesions including tumors c. shunt placement d. vascular procedures and segmenting the vasculature e. biopsy f. corridor based procedures g. planning and simulation of trajectories for stimulation and electrode recording. 2. Reviewing of existing treatment plans. Typical users of the software are medical professionals, including but not limited to surgeons and radiologists.

TGA Public Summary