RayStation 11.0

RaySearch Laboratories AB (publ) • Radiology • 09/08/2021

510(k)IEC 62304 Class C

Device Purpose

RayStation 11.0 is an advanced software system for radiation therapy and medical oncology, designed to propose, analyze, and administer treatment plans based on user inputs and configurable system functionality. Its methodology involves multiple integrated applications for planning (RayStation), machine commissioning (RayPhysics), and treatment delivery (RayTreat), notably incorporating new capabilities for CyberKnife M6/S7 planning validated with collapsed cone and photon Monte Carlo dose engines.

Summary

RayStation 11.0 is a software system designed for radiation therapy and medical oncology, facilitating treatment planning, analysis, and administration. Based on user input, it proposes treatment plans which, upon approval by authorized users, can be used for treatment delivery. The system comprises multiple applications: RayStation for treatment planning, RayPhysics for commissioning treatment machines and imaging systems, and RayTreat for sending plans to delivery devices and receiving treatment records. A key update in version 11.0 is the introduction of planning capabilities for M6/S7 CyberKnife linear accelerator treatment units, a feature not present in its predicate device, RayStation 10.1. The system utilizes fast and accurate dose and optimization engines, with specific validation performed for its CyberKnife planning functionality using collapsed cone and photon Monte Carlo dose engines. This validation confirmed the suitability of its dose computation for clinical use with M6/S7 CyberKnife machines. RayStation 11.0's technological characteristics are fundamentally similar to its predicate, built on the same software platform and developed under the same quality system. Comprehensive verification and validation, including system tests, risk analysis-based tests, unit/subsystem testing, dose engine validation, and user validation with cancer clinics, demonstrated that the system meets specifications and performs effectively.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

RayStation 11.0Radiation TherapyTreatment Planning SystemMedical OncologyCyberKnifeDose CalculationOptimization EnginesPhoton Monte CarloCollapsed ConeRayPhysics

Device Metadata

Submission Number

K211867

Company

RaySearch Laboratories AB (publ)

Panel

Radiology

Product Code

N/A

Data Type

Images

Clinical Function

Intervention

AI Function

Analysis

AI Subclass

quantification/feature localization

Relevant Clinical Questions

Q1. How does RayStation 11.0's planning capability for CyberKnife M6/S7 units compare in terms of plan quality and efficiency to dedicated CyberKnife planning systems?; What specific advancements or differences exist in the collapsed cone and photon Monte Carlo dose engines within RayStation 11.0 when applied to CyberKnife planning compared to other supported treatment modalities?; Could you elaborate on the technical reasons why RayStation 11.0 does not support older CyberKnife versions, and are there plans for future compatibility?; What range of configurable options does RayStation 11.0 offer, and how do these configurations specifically adapt the system for different clinical needs or machine types beyond CyberKnife?; What were the key findings or user feedback from the 'user validation in cooperation with cancer clinics' that influenced the final design and functionality of RayStation 11.0, particularly regarding CyberKnife integration?

Risk Classification

ESL Analysis

IEC 62304 ClassC

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class C (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score35/100

SBOM Evidence⚠ Not mentioned in summary

Cyber Risk Assessment✓ Detected in Summary

Postmarket Plan⚠ Not mentioned in summary

§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials(algorithm)

✓ Detected

SaaSBOMSoftware-as-a-Service Bill of Materials(platform)

✓ Detected

HBOMHardware Bill of Materials

- Not detected

CBOMCryptography Bill of Materials

- Not detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials(configuration)

✓ Detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of ML-BOM, SaaSBOM, OBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

• Not detected in AI-generated device summary: SBOM, HBOM, CBOM, VDR/VEX. These may be present in the full FDA submission.

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