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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
510K
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.
Clinical Applications
This device is commonly used in oncology departments for planning radiation therapy in cancer patients. It is utilized by radiation oncologists and medical physicists to develop personalized treatment plans. The system is suitable for use in hospitals and specialized cancer treatment centers, catering to a wide range of cancer types and stages.
Indications for Use
The FDA-cleared indications for RayStation 2024a SP3 involve its use in planning radiation therapy for patients requiring precise dose delivery. It is intended for use in patients undergoing treatment for various cancers, where accurate targeting of radiation is critical.
Practical Considerations
Clinicians should ensure compatibility with existing imaging systems and verify the integration of patient data. The device supports multiple radiation therapy techniques, so familiarity with these methods is beneficial. Regular software updates may be necessary to maintain optimal performance.
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.