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RayStation

RaySearch Laboratories AB (publ) • Radiology • 09/24/2020

510(k)IEC 62304 Class C
FDA Summary PDF

Device Purpose

RayStation 9.1/9.2 is an advanced software system designed to facilitate comprehensive radiation therapy treatment planning and analysis by integrating image fusion, sophisticated dose calculation, and machine learning capabilities. Its methodology involves a user-guided workflow for importing patient data, defining targets and critical structures, optimizing treatment parameters, and generating deliverable plans for precise radiation delivery.

Summary

RayStation 9.1/RayStation 9.2 is a comprehensive software system designed for radiation therapy treatment planning and analysis. Its core purpose is to enable clinically qualified radiation therapy staff to create, review, and approve treatment plans that provide precise treatment unit set-up parameters and estimate expected dose distributions for patient treatments. The system supports a wide array of functionalities, including the fusion of various imaging modalities like CT, PET, and MRI, advanced contouring tools for defining regions of interest, and sophisticated dose computation using methods like collapsed cone convolution. It is also compatible with 4D data, facilitates interfacing with treatment consoles, and incorporates advanced features such as machine learning for planning and segmentation, multi-criteria optimization, dose tracking, treatment adaptation, and deformable registration, all integrated into a single platform. The workflow within RayStation involves importing patient image data (typically CT images via DICOM), defining anatomical structures through contouring, and setting up a treatment plan which specifies the treatment machine, energy, and delivery type. Users then configure beam parameters, optimize the plan, and the system generates a deliverable plan, displaying it through 2D/3D dose visualizations, dose-volume histogram (DVH) curves, and detailed plan data. After thorough review and evaluation, the approved plan, along with associated dose information and structure sets, can be exported. Compared to its predecessor, RayStation 9.1/9.2 introduces usability enhancements, dose calculation capabilities based on dual-energy CT/SRS image data, updates for specific beam intensity calculations (e.g., Toshiba), and support for seated treatment positions.

AI Regulatory Concerns

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Keywords

Radiation TherapyTreatment Planning SystemDose ComputationImage FusionContouringMachine Learning PlanningMulti-criteria OptimizationDeformable RegistrationTreatment AdaptationDual-Energy CT

Device Metadata

Submission Number
K200569
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 the machine learning algorithm for automated planning and segmentation in RayStation 9.1/9.2 compare in terms of efficiency and accuracy to manual methods or other automated systems, particularly for complex cases?; What specific validation studies have been conducted to demonstrate the accuracy of the collapsed cone convolution dose computation, especially with the introduction of dual-energy CT data integration for dose calculation?; Can the system's multi-criteria optimization be customized to prioritize specific clinical objectives, and how does it handle conflicting optimization goals for target coverage versus organ-at-risk sparing?; What are the performance metrics and limitations of the deformable registration algorithms when dealing with significant anatomical changes between imaging datasets or during treatment adaptation?; How does the support for 'seated treatments' impact the planning workflow and dose calculation accuracy, and what specific considerations are needed for these non-conventional patient setups?

Risk Classification

ESL Analysis
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

Powered by SBOMator™

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 Score10/100
SBOM Evidence⚠ Not mentioned in summary
Cyber Risk Assessment⚠ Not mentioned 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(machine learning, algorithm, dataset)
✓ 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
- Not 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 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, OBOM. These may be present in the full FDA submission.

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RayStation - RaySearch Laboratories AB (publ) | ESL FDA AI Device Intelligence