ECHELON Synergy MRI system
FUJIFILM Healthcare CorporationThe ECHELON Synergy MRI system is an advanced 1.5 Tesla MRI scanner that generates high-quality diagnostic images of the head, body, spine, and extremities without ionizing radiation. It incorporates deep learning reconstruction (DLR) and other AI-powered functions like AutoPose and AutoClip to enhance image quality and improve workflow efficiency, helping radiologists diagnose conditions with improved image clarity and reduced scan times.
Intended Use
The ECHELON Synergy System is an imaging device intended to provide physiological and clinical information by producing internal structural images of the head, body, spine, or extremities using MR imaging without ionizing radiation.
Technology
The system uses a 1.5 Tesla superconducting magnet with open architecture; employs proton density, T1, T2, diffusion weighted imaging, MR angiography, and spectroscopy sequences; and integrates deep learning reconstruction (DLR), AutoPose, and AutoClip AI-powered software features to improve image quality and workflow.
Performance
The device was evaluated with recognized standards for safety and performance, including NEMA standards for SNR, geometric distortion, uniformity, and SAR. Clinical testing included a radiologist reader study demonstrating DLR produced images with equal or better quality than conventional images in noise, sharpness, and lesion conspicuity. AutoPose and AutoClip were validated to provide efficient and comparable performance to manual methods.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/14/2022
8 months - 2
FDA Approval
7/13/2023
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