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syngo.via RT Image Suite

Siemens Medical Solutions USA Inc. • Radiology • 07/30/2021

510(k)IEC 62304 Class C
FDA Summary PDF

Device Purpose

The syngo.via RT Image Suite (SOMARIS/8 VB60) is a software solution designed to support comprehensive radiation therapy treatment preparation through advanced multi-modality image visualization, manipulation, and contouring. It employs sophisticated image processing tools and incorporates a novel deep-learning algorithm for generating synthetic CT images from MRI data, aiming to enhance accuracy and workflow efficiency in radiotherapy planning.

Summary

The syngo.via RT Image Suite, software version SOMARIS/8 VB60, is an advanced image analysis software designed for radiation therapy planning. Its primary purpose is to facilitate the viewing, manipulation, 3D and 4D visualization, and comparison of medical images from diverse modalities such as CT, PET, MRI, and Linac CBCT. The software enables clinicians to perform crucial pre-treatment tasks, including the segmentation of tumors and organs-at-risk, manual and software-assisted contouring of volumes of interest, identification of points of interest like the isocenter, image registration, and the creation of simple geometric treatment plans, with final results exportable to treatment planning systems. This updated version introduces several modifications to existing features, enhancing usability and functionality in Reference Point Management, Patient Marking, Routine Contouring (with a new structure-cutting tool), and Structure Set Management. A significant advancement is the replacement of the atlas-based algorithm for generating synthetic CT images from MR acquisitions (for brain and pelvis) with a new deep-learning algorithm. Performance data for this AI-based synthetic CT demonstrates high geometric accuracy, with average body outline deviations less than 1 mm, and superior Hounsfield Unit (HU) accuracy compared to the predicate device, achieving values well within 50 HU for soft tissue and 200 HU for bone tissue. General workflow and parallel image display features have also been improved.

AI Regulatory Concerns

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Keywords

syngo.via RT Image SuiteRadiation Therapy PlanningImage Visualization (3D/4D)ContouringSegmentationSynthetic CTDeep-Learning AlgorithmMulti-modality ImagingDICOM RTOrgans-at-Risk (OARs)

Device Metadata

Submission Number
K211379
Company
Siemens Medical Solutions USA Inc.
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. How does the performance of the deep-learning algorithm for synthetic CT generation vary across different MRI sequences and patient demographics beyond brain and pelvis applications?; What specific usability improvements in Reference Point Management and Structure Set Management have demonstrated the most significant impact on clinical workflow efficiency?; Can the new tool for cutting a structure at a user-defined axial level in Routine Contouring be integrated with automated planning workflows, and what is its precision?; What are the computational time and resource requirements for the deep-learning based synthetic CT generation compared to the previous atlas-based method, particularly for brain and pelvis cases?; Are there plans to expand the deep-learning synthetic CT capabilities to other anatomical regions or to incorporate additional MR sequences for improved tissue differentiation and HU accuracy?

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 Score30/100
SBOM Evidence✓ Detected 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(software version)
✓ Detected
ML-BOMMachine Learning Bill of Materials(algorithm)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials
- Not 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 SBOM, ML-BOM 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: SaaSBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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syngo.via RT Image Suite - Siemens Medical Solutions USA Inc. | ESL FDA AI Device Intelligence