Medscape Medical NewsAll articles

RayStation

RaySearch Laboratories AB (publ) • Radiology • 06/19/2019

510(k)IEC 62304 Class C
FDA Summary PDF

Device Purpose

RayStation 8.1 is an advanced software system designed to streamline and enhance radiation therapy by providing comprehensive tools for treatment planning, dose calculation, and analysis using imaging data. It leverages technologies like machine learning, multi-criteria optimization, and deformable registration to create precise, individualized treatment plans, while offering improved usability and computational speed for clinical efficiency.

Summary

RayStation 8.1 is a sophisticated software system designed for the comprehensive planning and analysis of radiation therapy treatments. Its primary purpose is to generate precise treatment plans that provide radiation treatment unit set-up parameters and estimate dose distributions for proposed treatments, which are then reviewed and approved by clinically qualified radiation therapy staff before administration. The system integrates various imaging modalities such as CT, PET, and MRI, and allows for configurable functionality based on user needs, ensuring its adaptability to diverse clinical scenarios. The system operates through a detailed workflow that begins with patient data and image import (DICOM), followed by structure definition using advanced contouring tools, and plan setup specifying machine parameters and beam configurations. RayStation 8.1 incorporates advanced computational methods like collapsed cone convolution for dose computation and supports 4D data. Key technological advancements include machine learning for planning and segmentation, multi-criteria optimization, dose tracking, treatment adaptation, and deformable registration, all unified within a single platform. Compared to its predecessor, RayStation 7.0, version 8.1 offers significant improvements in usability, computational speed, and connectivity, while being built on the same core software platform and design principles.

AI Regulatory Concerns

Powered byJev by TypeSafe AI

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

Keywords

Radiation Therapy PlanningTreatment Planning SystemDose DistributionContouringImage Fusion (CTPETMRI)Machine Learning SegmentationMulti-criteria OptimizationDeformable Registration4D Data CompatibilityDICOM

Device Metadata

Submission Number
K190387
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 8.1 compare in terms of accuracy and efficiency to manual methods or other automated systems across various anatomical sites?; What specific metrics or validation studies support the claimed improvements in computational speed and usability in RayStation 8.1 compared to RayStation 7.0, particularly in complex cases involving adaptive radiotherapy?; Can the multi-criteria optimization feature be customized to incorporate novel radiobiological models or patient-reported outcome measures to further personalize treatment plans?; How does RayStation 8.1's deformable image registration algorithm handle large anatomical changes or inter-fractional variations, and what are its limitations in such scenarios?; What are the data requirements and integration capabilities of the dose tracking feature for facilitating effective adaptive radiation therapy workflows in real-time or near real-time clinical settings?

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

Learn how Parasoft automates IEC 62304 compliance testing →

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 Score15/100
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)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(connectivity, 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.

Preparing a similar submission?

ESL takes complete ownership of your software evidence work - SBOM & CVE remediation with SBOMator™, static analysis & unit testing with Parasoft, traceability, and full IEC 62304 lifecycle support.

Assess Your Readiness →Or contact ESL directly
RayStation - RaySearch Laboratories AB (publ) | ESL FDA AI Device Intelligence