Intended Use

EZFluence (RADEZ V2) is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields.

Technology

EZFluence (RADEZ V2) is a software-only device running on Windows, using CT, structure set, and treatment plan data (from DICOM and APIs) to generate optimized fluence files for radiotherapy planning. It supports dose estimation, constraint-based optimization, and user-defined customization, with new features like modulated therapy and expanded system compatibility.

Performance

Performance testing included software validation, simulated clinical scenarios, and usability analysis. The device's optimization and dose calculation features were validated against reference planning systems and workflows. All clinically relevant objectives and protocol goals were met, with DVH and dose constraints within accepted clinical tolerances, and the product was confirmed to function as intended across typical radiotherapy planning situations.

Predicate Devices

No predicate devices specified

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