📊 Evidence-Based Reference
Raystation 7
Raysearch Laboratories Ab (Publ)
Summary: RayStation 7 is a treatment planning system used primarily for radiation therapy. Key evidence includes studies on its use in photon and proton therapy, with a focus on dose accuracy and treatment planning efficiency.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K180379 ↗
Decision Date ?
April 25, 2018
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
RayStation 7 was cleared by the FDA through the 510(k) pathway on April 25, 2018. It is manufactured by Raysearch Laboratories Ab (Publ) and classified as a Class 2 device.
What It Is
RayStation 7 is a treatment planning system designed for radiation therapy. It facilitates the planning and optimization of radiation doses for cancer treatment, supporting various modalities including photon and proton therapy.
FDA-Cleared Indications
- Treatment planning for radiation therapy.
- Planning and optimization of radiation dose distributions for cancer treatment.
- Support for photon and proton radiation therapy planning.
Clinical Applications
- Planning intensity-modulated radiation therapy (IMRT).
- Planning volumetric-modulated arc therapy (VMAT).
- Planning photon radiation treatments.
- Planning proton radiation treatments.
- Calculating and optimizing radiation dose distributions before treatment delivery.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and technical evaluations. These studies span from 2022 to 2024.
Reported Outcomes
Published studies report that RayStation 7 provides accurate dose calculations and effective treatment planning for both photon and proton therapies. It has been shown to enhance workflow efficiency and support automated planning techniques, particularly in breast radiotherapy.
Safety Profile
Reported complications include potential inaccuracies in dose modeling for small-field apertures in proton therapy. However, the studies generally support the safety and reliability of RayStation 7 in clinical settings.
Evidence Limitations
The evidence base is limited by a lack of large-scale randomized controlled trials. Further research is needed to establish standardized guidelines for treatment planning across different radiation modalities.
Practical Considerations
- RayStation 7 is software, not an implanted or patient-contacting device; it does not have physical device sizes.
- Use requires compatible radiation therapy treatment machines, imaging systems, treatment-delivery systems, and clinical information systems.
- The treatment plan must be reviewed and approved by qualified radiation oncology professionals before treatment.
- MRI images may be incorporated into planning only when the imaging workflow, image registration, distortion correction, and safety procedures are validated by the treating institution.
- The software does not replace physician judgment, radiation safety procedures, independent dose checks, or required quality assurance.
Frequently Asked Questions
What are the clinical indications for RayStation 7?
RayStation 7 is indicated for use in planning radiation therapy treatments, including IMRT and VMAT, for cancer patients.
What outcomes have been reported in clinical studies?
Studies have reported accurate dose calculations and improved treatment planning efficiency with RayStation 7.
What complications have been reported?
Safety data indicates potential dose modeling inaccuracies in small-field proton therapy, but overall reliability is supported.
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.