Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation • Radiology • 03/09/2020
Device Purpose
The Vantage Galan 3T, MRT-3020, V6.0 is an advanced 3 Tesla MRI system designed for detailed anatomical imaging across various orientations, utilizing fundamental NMR principles. A key enhancement is the AiCE Reconstruction Processing Unit, which employs a Deep Convolutional Neural Network trained to specifically reduce Gaussian thermal noise, thereby improving image quality in brain and knee scans as validated by observer studies.
Summary
The Vantage Galan 3T, model MRT-3020, is a 3 Tesla Magnetic Resonance Imaging (MRI) system designed to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. It can perform non-contrast enhanced imaging, such as MRA, and its images represent the spatial distribution of protons based on NMR properties like proton density, T1 and T2 relaxation times, flow dynamics, and chemical shift. Contrast agents may be utilized depending on the region of interest, and the resulting images are intended to aid physicians in diagnosis. This iteration, V6.0, introduces the AiCE Reconstruction Processing Unit, an optional software and hardware component. AiCE employs Deep Convolutional Neural Network (DCNN) methods to improve image quality by reducing thermal noise. The DCNN is trained using datasets created by adding varying amplitudes of Gaussian noise to high-SNR images. Specifically targeted for brain and knee regions, AiCE's effectiveness was evaluated through Model Observer studies, which showed maintained or improved Low Contrast Detectability, and a Human Observer study with physicians demonstrating a statistical preference for AiCE-processed images over other filters.
AI Regulatory Concerns
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Keywords
Device Metadata
Relevant Clinical Questions
- Q1. How does the AiCE Deep Convolutional Neural Network architecture specifically differentiate between thermal noise and subtle pathological signals in brain and knee imaging?; What were the quantitative metrics for 'image quality' and 'low contrast detectability' used in the Model Observer and Human Observer studies, and how significant were the improvements with AiCE?; Are there specific patient populations or imaging protocols where AiCE reconstruction provides a more substantial benefit or, conversely, where its performance might be limited?; What is the computational overhead and processing time added by the AiCE Reconstruction Processing Unit compared to standard reconstruction, and how might this impact clinical workflow for high-throughput imaging centers?; How was the training dataset for the AiCE DCNN curated to ensure generalization across diverse patient anatomies and varying degrees of pathology within the targeted brain and knee regions?
Risk Classification
ESL AnalysisFDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement
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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.
Supply Chain BOM Evidence
Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.
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, HBOM 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, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.
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