Device Dossier

Radiation therapy treatment planning system, application program software

Device Dossier for Radiation therapy treatment planning system, application program software (Radiation therapy software, Class IIb, sponsor Elekta).…

Intended purpose

Monaco is a standalone Software as a Medical Device (SaMD). It is a Radiation Treatment Planning (RTP) system. It is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, proton and carbon treatment plans and displays, on-screen and in hard-copy, two-or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning.

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