Device Dossier

Radiology DICOM image processing application software

Device Dossier for Radiology DICOM image processing application software (Radiology DICOM image processing application software, Class IIa, sponsor…

Intended purpose

The Sim&Size software is a medical device intended to provide a 3D view of the final deployment of neurovascular implantable medical devices of type flow diverters, intrasaccular devices, stent devices and coils. It uses an actual image of the patient produced by 3D rotational angiography. It offers physicians the possibility of simulating the deployment of implantable medical devices in the artery to be treated and predicts the final placement and the extent of apposition of the implant. Sim&Size is not intended for diagnostic use or for recommending a specific treatment.

TGA Public Summary