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Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation • Radiology • 03/09/2020

510(k)IEC 62304 Class B
FDA Summary PDF

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

MRI3 TeslaAiCE ReconstructionDeep Convolutional Neural NetworkNoise ReductionImage QualityThermal NoiseBrain ImagingKnee ImagingMagnetic Resonance

Device Metadata

Submission Number
K192574
Company
Canon Medical Systems Corporation
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Generation
AI Subclass
image enhancement

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 Analysis
FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (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 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(training data, deep learning, neural network, dataset)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(server, network)
✓ Detected
HBOMHardware Bill of Materials(hardware)
✓ 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, 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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Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR - Canon Medical Systems Corporation | ESL FDA AI Device Intelligence