ECHELON Synergy MRI System
FUJIFILM Healthcare CorporationThe ECHELON Synergy MRI System is an advanced imaging device by FUJIFILM Healthcare Corporation that generates non-invasive, high-quality MRI images of the head, body, spine, and extremities. It uses a 1.5 Tesla superconducting magnet to produce detailed images based on proton density and other relaxation properties, aiding physicians in diagnosis without ionizing radiation. The addition of features like the Breast Coil 17 enhances its versatility while maintaining safety and effectiveness.
Intended Use
The ECHELON Synergy System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton Diagnostic uses: TI, T2, proton density weighted imaging, Diffusion weighted imaging, MR Angiography, Image processing, Spectroscopy, Whole Body
Technology
The ECHELON Synergy MRI System uses a 1.5 Tesla superconducting magnet in a gantry design, employing nuclear magnetic resonance principles to image protons in the body. It has control and image processing hardware and software substantially equivalent to the legally marketed predicate device ECHELON Synergy V10.0 (K233687), with additions like Breast Coil 17. Images are generated based on proton density and magnetic relaxation times (T1, T2), flow, and diffusion, enabling a variety of weighted imaging including diffusion and MR angiography. Safety and performance conform to international standards (IEC, NEMA).
Performance
The device underwent bench testing and clinical image validation to confirm the new features perform as intended with adequate image quality for clinical use. The system conforms to applicable safety and performance standards (including IEC 60601 series and NEMA standards) and shows no effect on existing standard test results compared to predicate device K233687. Clinical testing included radiologist validation of clinical images for usability and safety.
Predicate Devices
No predicate devices specified
Ready to Sharpen Your Edge?
Subscribe to join 11k+ 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.