Device Dossier
Radiation therapy software
Device Dossier for Radiation therapy software (Radiation therapy software, Class IIa, sponsor Seetreat). ARTG record, intended purpose, GMDN category —…
- GMDN category: Radiation therapy software
Intended purpose
ART.1 is a software as a medical device intended to support the treatment re-plan process for cancer patients receiving radiation therapy. ART.1 calculates delivered dose and contours based on cancer patients’ daily volumetric images, in addition to displaying and reporting relevant metrics. ART.1 allows for the comparison of dosimetry between the delivery of each fraction and the treatment plan in radiation oncology. ART.1 is intended for use by trained medical professionals as a decision support tool to aid the treatment re-plan process.