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RayStation 10.1

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210645

by RaySearch Laboratories AB (PUBL)

Identifiers

510(k) Number
K210645 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 10.1 is a Radiation Therapy Treatment Planning System designed for advanced radiotherapy planning. It integrates multi-criteria optimization and adaptive therapy capabilities to support external beam therapy, brachytherapy, and particle therapy (including protons, helium, and carbon ions). The system facilitates precise dose calculations and treatment planning across diverse radiation modalities, enhancing treatment accuracy and customization for complex cases.

This software-based system is intended for use in radiology departments and oncology centers, where it aids clinicians in generating optimized treatment plans. Supplied as a standalone software solution, it requires compatible hardware and network infrastructure for operation. The device holds FDA 510(k) clearance (K210645) under the Radiology advisory committee, classified as a Class II medical device under regulation 892.5050. No sterility or single-use requirements apply, as it is a reusable digital platform.

Frequently asked questions

What is RayStation 10.1 used for?

RayStation 10.1 is a Radiation Therapy Treatment Planning System designed to assist clinicians in creating optimized treatment plans for external beam therapy, brachytherapy, and particle therapy (including protons, helium, and carbon ions). It integrates multi-criteria optimization and adaptive therapy capabilities to improve dose accuracy and customization for complex radiotherapy cases, particularly in radiology departments and oncology centers.

How is RayStation 10.1 supplied and what hardware does it require?

RayStation 10.1 is supplied as a standalone software solution. To operate, it requires compatible hardware infrastructure and a network setup, as it is not a standalone physical device but a digital platform. The system does not include hardware components and must be installed on approved servers or workstations within a clinical environment.

Is RayStation 10.1 sterile or single-use?

RayStation 10.1 is neither sterile nor single-use. It is a reusable digital platform, meaning it can be used repeatedly across multiple patients and treatment sessions without disposal. Sterility is irrelevant for software-based medical devices, as they are not physical objects exposed to sterile environments.

What regulatory approval does RayStation 10.1 hold?

RayStation 10.1 holds FDA 510(k) clearance under the Radiology advisory committee, classified as a Class II medical device under regulation 892.5050. The clearance (K210645) confirms it is substantially equivalent to a predicate device, allowing its use in radiation therapy planning within authorized clinical settings.

Does RayStation 10.1 support multiple radiation modalities?

Yes, RayStation 10.1 supports multiple radiation modalities, including external beam therapy, brachytherapy, and particle therapy (protons, helium, and carbon ions). Its multi-criteria optimization and adaptive therapy features enable precise dose calculations and tailored treatment planning across these diverse modalities, enhancing flexibility for complex clinical cases.

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: Treatment Planning System - RayStation | RaySearch Laboratories, RayStation 10.1 | RaySearch Laboratories AB (publ) radiology AI profile, K210645 - RayStation 10.1 - Radiology, RayStation 10.1 | FDA Radiology AI Device - radaislice.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
RaySearch Laboratories AB (PUBL)

Sources (1)

  • FDA 510(k) K210645 24 fields · synced Oct 1, 2026