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

RaySearch Laboratories AB's RayStation and RayPlan software versions (2023B, 2024A, 2024A SP3) are validated Class II Medical Charged-Particle Radiation Therapy Systems designed to generate and facilitate the administration of radiation treatment plans. Through comprehensive verification and validation, including assessment of advanced features like VMAT sequencing and proton PBS dose resolution, the software has demonstrated substantial equivalence and compliance with safety and effectiveness standards, enabling its clinical market entry.

RaySearch Laboratories AB's RayStation and RayPlan software, specifically versions 2023B, 2024A, and 2024A SP3, are classified as Class II Medical Charged-Particle Radiation Therapy Systems. These software versions are designed to propose radiation treatment plans based on user input, and following review and approval, can also be used for treatment administration. The software has been determined to be substantially equivalent to previously marketed devices, thereby permitting its commercialization, subject to adherence to general regulatory controls such as annual registration, device listing, and good manufacturing practices. Rigorous software verification and validation testing, classifying the software as a "Major" level of concern, were conducted, including cybersecurity and interoperability assessments. These tests confirmed compliance with recognized consensus standards, such as IEC 61217, IEC 62304, and ISO 14971. The evaluation specifically demonstrated that updated features, including improved VMAT sequencing, higher dose grid resolution for proton PBS, automated field-in-field planning, and LET optimization, do not introduce new questions of safety or effectiveness when compared to the predicate device, RayStation 12A.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific clinical benefits or improvements do the new features like LET optimization or automated field-in-field planning offer over previous versions for patient outcomes?; How does the "Major" level of concern classification impact the software's implementation and ongoing post-market surveillance requirements for clinical users?; Could you elaborate on the methodology and specific scenarios tested during cybersecurity and interoperability assessments, given the software's role in treatment administration?; What are the limitations, if any, of the higher dose grid resolution for proton PBS in terms of computational time or required hardware specifications?; Beyond the stated updates, are there any known areas for future development or improvements identified during the validation process for these software versions?