Device Dossier

Radiation therapy software

Device Dossier for Radiation therapy software (Radiation therapy software, Class IIb, sponsor RQSolutions Medical Devices Distribution Support). ARTG…

Intended purpose

The device is a software-only medical device and intended for male patients with localized prostate cancer or prostate cancer with pelvic lymph node involvement who are undergoing external beam radiation therapy treatment.The software uses machine learning-based algorithms to automatically produce 3D dose distributions from patient-specific anatomical geometry and target dose prescription.The device is not intended to be used for disease diagnosis and treatment decision purposes in clinical workflows.

TGA Public Summary