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The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron 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. It uses generally accepted methods for: · contouring - · image manipulation - · simulation - · image fusion - plan optimization - · QA and plan review

Monaco is a radiation treatment planning system that first received FDA clearance in 2007 (K071938). The modified system received clearance in 2009, when Volumetric Modulated Arc Therapy (VMAT) planning capability was added (K091179), again when Dynamic Conformal Arc planning was added (K110730), and electron planning, support for stereotactic cones, and SUV calculation were added (K132971). Specialty image creation was added in 2015 (K151233), and adaptive planning and dose calculation in the presence of a magnetic field (e.g., MR-Linac) was added in 2018 (K183037). A 510(k) was filed in 2017 for the addition of carbon ion planning. The 510(k) was withdrawn because there was no hardware cleared for the US market capable of delivering carbon ion plans. Monaco's carbon ion planning functionality remains licensed off and inaccessible to US users. The Monaco system accepts patient imaging data and "source" dosimetry data from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation on these diagnostic images. Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of a beam modifier (MLC, block, etc.) between the source of radiation and the patient to shape the beam. The Monaco system then produces a display of radiation dose distribution within the patient, indicating doses to the target volume and surrounding structures. The "best" plan satisfying the clinican prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.