Medscape Medical NewsAll articles

ECHELON Synergy MRI system

FUJIFILM Healthcare Corporation • Radiology • 07/13/2023

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

The ECHELON Synergy MRI system is a 1.5 Tesla diagnostic imaging device designed for non-invasive anatomical and physiological assessment, generating images based on nuclear magnetic resonance principles including proton density and T1/T2 relaxation times. It aims to enhance clinical utility through updated hardware, including a redesigned gantry and RF system, new RF coils, and advanced software features like Deep Learning Reconstruction and automated workflow tools to improve image quality and operational efficiency.

Summary

The ECHELON Synergy MRI system is an imaging device designed to provide physicians with non-invasive physiological and clinical information for diagnostic purposes, without the use of ionizing radiation. It produces transverse, coronal, sagittal, oblique, and curved cross-sectional images of the head, body, or extremities, reflecting the spatial distribution of protons (hydrogen nuclei) and their magnetic resonance properties such as proton density, T1 (spin-lattice) and T2 (spin-spin) relaxation times, and flow. The system's diagnostic applications include T1, T2, and proton density weighted imaging, diffusion-weighted imaging, MR angiography, image processing, spectroscopy, and whole-body imaging, all based on the principles of nuclear magnetic resonance where atomic nuclei are excited by radiofrequency pulses in a strong magnetic field, and the emitted signals during relaxation are used to reconstruct images. Building upon the ECHELON OVAL V6.0A, the ECHELON Synergy features a 1.5 Tesla superconducting magnet and introduces an open architecture to enhance clinical utility. Key technological modifications include a circular 70cm gantry bore, adjusted gradient system specifications (33mT/m strength, 130 T/m/sec slew rate), and an updated RF system with a single transmitter channel and 18kW peak power. The system incorporates new and revised RF coils (e.g., FlexFit Neuro Coil, FlexFit Blanket Coil), and operates on an updated software platform (V9.0A) with advanced functionalities like AutoPose for automated slice positioning (knee, shoulder, spine), AutoClip for image processing, and Deep Learning Reconstruction (DLR). Clinical evaluations confirmed these new features perform as intended, with DLR demonstrating equivalent or superior image quality (SNR, sharpness, lesion conspicuity) compared to conventional methods, even with shorter scan times, and AutoPose improving workflow efficiency.

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

Magnetic Resonance Imaging1.5 TeslaDeep Learning Reconstruction (DLR)RF CoilsPulse SequencesNon-invasive ImagingProton Density ImagingT1/T2 Weighted ImagingAutomated WorkflowSuperconducting Magnet

Device Metadata

Submission Number
K223426
Company
FUJIFILM Healthcare Corporation
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Generation
AI Subclass
acquisition guidance|image enhancement

Relevant Clinical Questions

  • Q1. What specific benefits does the circular 70cm bore offer in terms of patient experience or imaging capabilities compared to the previous oval design, especially considering the slightly reduced gradient strength and slew rate?; How does the Deep Learning Reconstruction (DLR) algorithm handle diverse patient populations and varying pathologies to ensure consistent image quality improvement without introducing artifacts or misinterpretations?; With the reduction in RF transmitter channels from 2 to 1 and decreased peak envelope power, what technological advancements in the RF system or coils compensate to maintain or improve signal quality and acquisition speed for the ECHELON Synergy?; Can the 'AutoPose' and 'AutoClip' features be customized or fine-tuned by technologists for non-standard anatomies or specific clinical requirements within the ECHELON Synergy system?; What are the practical implications for imaging protocols and diagnostic capabilities resulting from the new pulse sequences (e.g., 3D Soft RSSG, 2D T1Map) and the integration of previous sequences in the ECHELON Synergy?

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

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 Score20/100
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(deep learning, algorithm)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(platform)
✓ 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(operational)
✓ 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, OBOM 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. 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
ECHELON Synergy MRI system - FUJIFILM Healthcare Corporation | ESL FDA AI Device Intelligence