ECHELON Synergy V10.0
Fujifilm Healthcare Americas CorporationThe ECHELON Synergy V10.0 MRI system by Fujifilm Healthcare Americas Corporation is an advanced magnetic resonance imaging device that produces detailed cross-sectional images of the body using non-ionizing magnetic fields. It helps physicians diagnose various conditions by providing high-quality images reflecting tissue properties such as proton density and relaxation times. This system includes updated software features with AI-powered image processing to improve image quality and workflow efficiency, benefiting both clinicians and patients.
Intended Use
The ECHELON Synergy System is an imaging device intended to provide physicians with physiological and clinical information obtained non-invasively without ionizing radiation by producing various weighted MRI images for diagnosis.
Technology
The system uses a 1.5 Tesla superconducting magnet with RF coils for proton excitation and signal reception. It employs pulse sequences and magnetic field gradients to spatially encode signals, creating images that emphasize T1, T2, proton density, diffusion, angiography, spectroscopy, and whole-body imaging. New AI-based software features (DLR Clear, AutoPose) enhance image reconstruction and positioning.
Performance
Performance testing included bench testing and clinical validation demonstrating that new AI-based features like DLR Clear improve image quality by reducing artifacts and increasing sharpness and spatial resolution. Clinical testing with radiologists showed these images were clinically acceptable and superior in quality compared to conventional methods. AutoPose positioning tools reduced scan setup time.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/17/2023
5 months - 2
FDA Approval
5/3/2024
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.