Medscape Medical NewsAll articles

RayStation 12A

RaySearch Laboratories AB (publ) • Radiology • 03/29/2023

510(k)IEC 62304 Class C
FDA Summary PDF

Device Purpose

RayStation 12A is an advanced software system designed for precise radiation therapy and medical oncology treatment planning, analysis, and administration, utilizing user-driven inputs and sophisticated computational algorithms. Its methodology relies on peer-reviewed plan optimization, diverse dose calculation engines including Monte Carlo and TG43, and introduces enhanced features like wedged eye planning, automatic field-in-field planning, and expanded brachytherapy compatibility to improve treatment outcomes.

Summary

RayStation 12A is a software system intended for radiation therapy and medical oncology, facilitating the creation, analysis, and administration of treatment plans. It operates based on user input to propose plans which, upon review and approval by authorized users, can be used for treatment delivery. The system comprises several applications: the main RayStation application for treatment planning, RayPhysics for commissioning treatment machines and imaging systems, and RayTreat for interfacing with treatment delivery devices. These applications are built on a software platform utilizing Microsoft SQL databases for data storage, and its scientific foundation lies in the implementation of peer-reviewed algorithms for plan parameter optimization and both photon and particle dose calculation. This version, RayStation 12A, introduces several modified features compared to its predecessor. These include support for eye planning with wedges to enhance dose conformity and spare organs at risk, automatic field-in-field planning to achieve uniform target doses using 3D-CRT segments, and expanded brachytherapy support for Elekta Flexitron® afterloaders validated with the TG43 formalism. Additionally, the electron Monte Carlo dose engine has been updated, replacing a previous plug-in with a fully integrated solution designed to improve accuracy, particularly for small cutout sizes. Non-clinical performance data and software verification and validation testing were conducted to support these new functionalities, demonstrating their intended performance through comparisons with reference doses from various sources, including published data, measurements, and other established systems.

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 therapyTreatment planning systemMonte CarloBrachytherapyEye planningField-in-fieldDose calculationElekta FlexitronElectron beamsProton therapy

Device Metadata

Submission Number
K222312
Company
RaySearch Laboratories AB (publ)
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Intervention
AI Function
Generation|Analysis
AI Subclass
quantification/feature localization|synthetic data generation

Relevant Clinical Questions

  • Q1. The updated electron Monte Carlo dose engine in RayStation 12A replaced the VMC++ plug-in and claims increased accuracy for small cutout sizes. What specific algorithmic or modeling changes contribute to this improved accuracy, and how was this quantified beyond general gamma pass rates against BEAMnrc/egs++?; For the 'Automatic field-in-field planning' feature, what are the underlying optimization principles used to sequentially add segments and determine their apertures and weights for achieving uniform target dose, and how robust is this feature for complex or concave target volumes?; Regarding the brachytherapy support for Elekta Flexitron afterloaders using the TG43 formalism, what specific source models are supported, and how does the system manage variations in source calibration or applicator geometry compared to the predicate device?; The 'eye planning with wedges' feature aims to improve dose conformity. What range of wedge designs (e.g., physical vs. dynamic, material, angle) are supported, and what validation data demonstrate its superiority over non-wedged eye plans in sparing critical ocular structures like the lens or optic nerve?; RayStation 12A integrates multiple applications (RayStation, RayPhysics, RayTreat). How does the system ensure data integrity and consistency across these applications and the Microsoft SQL databases, particularly when modifications are made in one module that impact others, such as machine commissioning in RayPhysics affecting planning in RayStation?

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 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(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
- 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.

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 12A - RaySearch Laboratories AB (publ) | ESL FDA AI Device Intelligence