📋 FDA Reference
Raystation 2023b Rayplan 2023b Raystation 2024a Rayplan 2024a Raystation 2024a SP3 Rayplan 2024a SP3
Raysearch Laboratories Ab (Publ)
Summary: RayStation 2024a SP3 is a medical device used in radiation therapy planning, primarily by oncologists and medical physicists. It assists in creating precise treatment plans for cancer patients.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K240398 ↗
Decision Date ?
April 4, 2025
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
RayStation 2024a SP3 was cleared through the FDA 510(k) pathway on April 4, 2025. Manufactured by Raysearch Laboratories Ab (Publ), it is classified as a Class 2 device.
What It Is
RayStation 2024a SP3 is an advanced treatment planning system used in radiation oncology. It integrates imaging data to help clinicians design and optimize radiation therapy plans. The system supports various modalities, including IMRT and VMAT, and offers tools for dose calculation and plan evaluation.
FDA-Cleared Indications
- For use by qualified healthcare professionals to support radiation therapy treatment planning.
- For importing and using patient imaging and related clinical information in the development and evaluation of radiation treatment plans.
- For planning and evaluating radiation treatments delivered with supported radiation therapy techniques and equipment.
Clinical Applications
- Creating radiation treatment plans for patients with cancer.
- Optimizing intensity-modulated radiation therapy plans.
- Optimizing volumetric-modulated arc therapy plans.
- Calculating and evaluating radiation dose distributions before treatment.
- Supporting treatment planning workflows in hospitals and radiation oncology centers.
Practical Considerations
- The software must be configured and validated for compatibility with the treatment machines, imaging systems, oncology information systems, and dose-calculation workflows used by the facility.
- Use requires qualified radiation oncologists, medical physicists, dosimetrists, and other trained staff, with independent plan checks and quality assurance before treatment.
- The system is software rather than an implantable or patient-contact device; it has no physical device size and is not classified as MRI safe or unsafe.
- Imaging, patient-contour, prescription, and treatment-machine data should be verified before plan approval because errors in imported or entered information can affect the treatment plan.
- Software updates and configuration changes require appropriate testing, documentation, cybersecurity review, and clinical quality assurance.
Frequently Asked Questions
What is RayStation 2024a SP3 used for?
It is used for planning and optimizing radiation therapy treatments for cancer patients.
What specialties typically use this device?
Radiation oncologists and medical physicists typically use this device in oncology settings.
What are the FDA-cleared indications?
It is indicated for planning radiation therapy in patients needing precise radiation dose delivery for cancer treatment.
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.