ECHELON Synergy

The ECHELON Synergy is a 1.5 Tesla magnetic resonance imaging (MRI) system that produces cross-sectional images of the head, body, spine, and extremities without ionizing radiation. It provides physiological and clinical information useful for diagnostic purposes through various imaging modes including T1/T2-weighted imaging, diffusion-weighted imaging, MR angiography, spectroscopy, and whole-body imaging.

The ECHELON Synergy differs from its predicate (K241429) by adding: an alternative ZeroHelium superconducting magnet, a dockable patient table option, an alternative approved PMM monitor (K152330), an additional Spine Coil B, and updated application software (V11.0A) with new positioning applications (AutoPose), enhanced image processing (MPR improvements), and machine learning features (DLR Symmetry). Core specifications remain identical: 1.5 Tesla field strength, 33 mT/m gradient strength, 63.86 MHz resonant frequency, and 32 RF receiver channels.

NEMA MS 1-5, MS 8, and MS 14 (for MRI image quality and acoustic performance); IEC 60601-1, 60601-1-2, 60601-2-33, and 62304 (for electrical safety, electromagnetic compatibility, and software life cycle); IEC 60825-1 (for laser safety).

The device is substantially equivalent because alternative hardware components (magnet, patient table, monitor, coil) perform the same functions under identical regulatory controls as the predicate with no significant technological changes in safety or effectiveness. Software enhancements (AutoPose positioning and DLR Symmetry artifact reduction) do not constitute new intended uses and are controlled within the same safety limits as the predicate. Clinical and phantom testing of new features demonstrated acceptable image quality without degradation, and all system standards compliance testing conducted on the predicate applies equally to the subject device.