đź“Š Evidence-Based Reference
Raystation 10 1
Raysearch Laboratories Ab (Publ)
Summary: RayStation 10 1 is a treatment planning system for radiation therapy, cleared by the FDA. It is primarily used for creating dose volume histograms in radiation therapy planning. Key evidence includes a multicenter evaluation of dosimetric systems.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K210645 ↗
Decision Date ?
June 29, 2021
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
RayStation 10 1 was cleared by the FDA through the 510(k) pathway on June 29, 2021. It is manufactured by Raysearch Laboratories Ab (Publ) and classified as a Class 2 device.
What It Is
RayStation 10 1 is a sophisticated treatment planning system designed for radiation therapy. It facilitates the creation of dose volume histograms and supports various intensity-modulated radiation therapy techniques.
FDA-Cleared Indications
- For use as a treatment planning system in radiation therapy.
- Supports the planning and evaluation of radiation treatment dose distributions.
- Supports intensity-modulated radiation therapy planning techniques as specified in the device labeling.
Clinical Applications
- Creating radiation therapy treatment plans for oncology patients.
- Optimizing radiation dose distribution around target tissues and nearby organs.
- Generating dose-volume histograms for treatment-plan evaluation.
- Supporting intensity-modulated radiation therapy planning.
- Evaluating radiation plans for sites such as the breast and chest wall when clinically appropriate and consistent with the labeling.
Evidence Summary
The available literature includes three studies, ranging from 2023 to 2025. These studies encompass retrospective analyses and multicenter evaluations, focusing on dosimetric consistency and technique recommendations.
Reported Outcomes
Published studies report that RayStation 10 1 provides consistent dose volume histogram creation across different systems. It supports various intensity-modulated techniques, enhancing treatment precision for breast radiotherapy.
Safety Profile
Reported complications include potential inconsistencies in dose reporting across different systems, as highlighted in multicenter evaluations. No direct adverse events related to the device were noted in the studies.
Evidence Limitations
The evidence is limited by the retrospective nature of some studies and the focus on specific clinical scenarios. Further research is needed to explore broader applications and long-term outcomes.
Practical Considerations
- RayStation 10 1 is software, not an implanted or disposable device; it does not have a physical size or vascular compatibility requirements.
- It must be used with compatible imaging, treatment-delivery, oncology information, and record-and-verify systems validated by the treating facility.
- Treatment plans require review and approval by qualified radiation oncology professionals before delivery.
- MRI, CT, PET, and other imaging data may be used only when the imaging workflow, image registration, and software compatibility have been appropriately validated.
- The software does not replace clinical judgment, quality assurance, machine checks, or required patient-specific treatment-plan verification.
Frequently Asked Questions
What are the clinical indications for RayStation 10 1?
RayStation 10 1 is indicated for use in radiation therapy planning, particularly for creating dose volume histograms and supporting intensity-modulated techniques.
What outcomes have been reported in clinical studies?
Studies report consistent dose volume histogram creation and support for various intensity-modulated techniques, enhancing treatment precision.
What complications have been reported?
Reported complications include potential inconsistencies in dose reporting across systems, but no direct adverse events related to the device were noted.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.