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Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation • Radiology • 12/01/2021

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

The Vantage Fortian 1.5T (MRT-1550, V8.0) is a magnetic resonance diagnostic device designed to generate detailed anatomical images by leveraging NMR principles and incorporating AiCE reconstruction technology. It aims to enhance diagnostic capabilities and workflow efficiency through specific hardware modifications and a suite of advanced software features, including novel artifact suppression methods, non-contrast perfusion imaging, iterative motion correction, and machine learning-driven automated scan planning.

Summary

The Vantage Fortian 1.5T, model MRT-1550, V8.0, is a diagnostic imaging system utilizing a 1.5 Tesla magnetic field to produce cross-sectional anatomical images of the head or body. It employs nuclear magnetic resonance (NMR) principles, analyzing properties such as proton density, T1 and T2 relaxation times, flow dynamics, and chemical shift, and is capable of non-contrast enhanced imaging like MRA. The system features a 1.4m short magnet, Pianissimo™ Σ and Pianissimo Zen scan noise reduction technologies, and a maximum field of view of 55x55x50 cm. Hardware modifications from its predicate include a changed gantry color, a single-channel 24kW RF amplifier (from dual-channel 30kW), adjusted gradient performance (35 mT/m amplitude, 155 mT/m/ms slew rate), a new gradient coil, a modified whole-body coil, and changes to the water cooling system. Significant software enhancements in V8.0 include the AiCE Reconstruction Processing Unit, new artifact suppression techniques like mART EXP (3D method for distortion) and RDC DWI (reduces phase encoding distortion for SEEPI2D), pseudo-continuous Arterial Spin Labeling (pCASL) for non-contrast perfusion imaging, and Iterative Motion Correction (IMC). It also introduces machine learning-based automated scan planning tools: SureVOI Liver, LiverLine+, ProstateLine+, and W-SpineLine+. The Exsper sequence has been expanded to FSE2D. Accessories include a ceiling camera for patient positioning and tablet applications for exam preparation and monitoring. Testing confirmed the functionality of these new software features, with volunteer and phantom studies demonstrating diagnostic image quality, effective artifact and motion reduction, and accurate automated planning and perfusion measurements.

AI Regulatory Concerns

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Keywords

Magnetic Resonance Imaging1.5 TeslaAiCE ReconstructionArtifact SuppressionmART EXPRDC DWIpCASLIterative Motion CorrectionAutomated Scan PlanningPianissimo Technology

Device Metadata

Submission Number
K213305
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 performance of the AiCE Reconstruction Processing Unit in the Vantage Fortian 1.5T specifically improve image quality (e.g., SNR, resolution, artifact reduction) compared to systems without AiCE, particularly for the newly introduced software features like mART EXP and RDC DWI?; What is the quantitative impact of the new gradient coil and modified RF system (1ch, 24kW) on image acquisition times and overall image signal-to-noise ratio across different anatomical regions and sequences?; For the machine learning-based automated scan planning tools (SureVOI Liver, LiverLine+, ProstateLine+, W-SpineLine+), what is their documented accuracy and time-saving potential in diverse patient populations and how do they adapt to anatomical variations or pathologies?; Can you provide data on the diagnostic efficacy of pCASL for perfusion-weighted imaging on this system, particularly in comparison to contrast-enhanced methods for relevant clinical scenarios?; What are the specific advantages and potential trade-offs of the Pianissimo™ Σ technology in conjunction with the other hardware changes in terms of acoustic noise reduction versus image quality parameters like scan time or SAR levels?

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 Score25/100
SBOM Evidence⚠ Not mentioned in summary
Cyber Risk Assessment⚠ Not mentioned in summary
Postmarket Plan✓ Detected 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, labeling)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials
- Not detected
HBOMHardware Bill of Materials(hardware, camera)
✓ 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, HBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Not detected in AI-generated device summary: SBOM, SaaSBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR - Canon Medical Systems Corporation | ESL FDA AI Device Intelligence