RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

RayStation/RayPlan is a software system for radiation therapy treatment planning and medical oncology. Based on user input, it proposes treatment plans; after review and approval by authorized users, it can also administer treatments. The system supports multiple radiotherapy modalities including photon, electron, proton, and brachytherapy techniques.

The subject device (2024A SP3, 2024A, 2023B) is compared to predicate RayStation 12A. Key enhancements include improved sliding window VMAT sequencing, higher dose grid resolution for proton PBS (down to 0.5 mm), automated field-in-field planning, LET optimization for protons, segment weight optimization with photon Monte Carlo, and various workflow improvements. Hardware platform, operating system, target population, and anatomical sites remain substantially equivalent.

IEC 61217 (radiotherapy equipment coordinates), IEC 62304 (medical device software lifecycle), IEC 62366-1 (usability engineering), ISO 14971 (risk management), IEC 62083 (radiotherapy treatment planning systems), and IEC 81001-5-1 (health software security).

All added/updated functions were evaluated as raising no new or different questions of safety or effectiveness compared to the predicate. Software verification and validation through unit, integration, and system-level testing demonstrated conformance to specifications. Dose engine validation using gamma evaluation criteria and measurement comparisons showed the subject device performs as accurately as the predicate. Clinical validation in the intended use environment confirmed workflows and functionality are safe and effective. No new safety risks or architectural changes affect cybersecurity, network capabilities, or core treatment planning principles.