Identifiers
- 510(k) Number
- K200569 FDA 510(k)
- FDA Product Code
- MUJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
RayStation is a treatment planning system for radiation therapy treatment. It is a software device used in radiation therapy of cancer.
RayStation is supplied as a software system and is regulated under FDA 510(k) clearance with product code MUJ and regulation number 892.5050. It is classified as a Class II device and is used in radiology settings.
Frequently asked questions
What is the primary purpose of RayStation in a clinical setting?
RayStation is a treatment planning system specifically designed for radiation therapy of cancer. It is a software-based tool used by radiologists and oncologists to create precise treatment plans for delivering radiation doses to tumor sites while minimizing exposure to healthy tissue.
How is RayStation supplied, and is it a single-use or reusable device?
RayStation is supplied exclusively as a software system and is not a physical medical device. Since it is software, it is not subject to single-use or reuse considerations—it is installed on hospital or clinic computers and requires periodic updates rather than disposal after use.
What regulatory pathway was followed for FDA clearance of RayStation?
RayStation received FDA 510(k) clearance under the Traditional 510(k) Review pathway, classified as a Class II device with product code MUJ (Radiation Therapy Treatment Planning Systems). The submission was reviewed by the Radiology (RA) Advisory Committee and determined to be substantially equivalent to a predicate device.
Does RayStation require any special storage conditions after installation?
As a software-based system, RayStation does not require physical storage like traditional medical devices. However, it must be installed on compatible hardware meeting the manufacturer’s system requirements, and regular software updates are necessary to ensure functionality and compliance with evolving clinical standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Software in radiation therapy and oncology | RaySearch Laboratories, Treatment Planning System - RayStation | RaySearch Laboratories, RaySearch Laboratories - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200569 | Class II | Active |
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Manufacturer
- Manufacturer
- RaySearch Laboratories AB (PUBL)
Sources (1)
- FDA 510(k) K200569 24 fields · synced Sep 19, 2026