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raystation 12a
Raysearch Laboratories Ab (Publ)
Summary: RayStation 12a is a treatment planning system primarily used for radiotherapy. It is FDA-cleared and supported by studies focusing on automated planning and dosimetric comparisons.
FDA Clearance Information
Pathway
510K
Number
K222312 ↗
Decision Date
March 29, 2023
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RayStation 12a received FDA clearance through the 510(k) pathway on March 29, 2023. It is manufactured by Raysearch Laboratories Ab (Publ) and classified as a Class 2 device.
What It Is
RayStation 12a is a treatment planning system designed for radiotherapy applications. It facilitates the creation of precise treatment plans by optimizing dose distribution for volumetric modulated arc therapy (VMAT) and other techniques.
Clinical Applications
RayStation 12a is commonly used in clinical scenarios requiring precise radiotherapy planning, such as lung cancer treatment and proton therapy. It aids in optimizing dose delivery while sparing organs-at-risk.
Evidence Summary
The available literature includes six studies, encompassing randomized controlled trials and retrospective analyses, published between 2024 and 2025. These studies focus on automated planning, dosimetric comparisons, and optimization strategies.
Reported Outcomes
Published studies report that RayStation 12a enhances treatment planning efficiency and accuracy, particularly in VMAT for lung cancer. Dosimetric comparisons indicate improved plan quality over previous systems, and optimization strategies show potential in enhancing therapeutic outcomes.
Safety Profile
Reported complications include variability in plan quality due to planner experience and potential uncertainties in hyperthermia delivery. No significant adverse events were noted in the studies reviewed.
Evidence Limitations
The evidence is limited by the variability in planner experience and the need for further research on long-term outcomes. Some studies also highlight the need for improved strategies to manage hyperthermia delivery uncertainties.
Frequently Asked Questions
What are the clinical indications for RayStation 12a?
RayStation 12a is indicated for use in radiotherapy treatment planning, particularly for volumetric modulated arc therapy and proton therapy.
What outcomes have been reported in clinical studies?
Studies report enhanced treatment planning efficiency and accuracy, with improved dosimetric outcomes in VMAT and other radiotherapy techniques.
What complications have been reported?
Reported complications include variability in plan quality and uncertainties in hyperthermia delivery, though no significant adverse events 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.