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
Simpleware Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. The software is intended to inform clinical management by improving confidence in clinical decision-making and pre-surgical planning through use of patient-specific 3D models (virtual 3D models and 3D printed anatomical models) created from medical imaging. Outputs from the software must be reviewed for clinical suitability by expert clinicians working on specific patient cases.