ECHELON Synergy V10.0

The ECHELON Synergy V10.0 is a 1.5 Tesla Magnetic Resonance Imaging (MRI) system intended to provide physicians with non-invasive physiological and clinical information through detailed cross-sectional images of the head, body, and extremities for diagnostic determination. It operates on the scientific principles of nuclear magnetic resonance, exciting protons and analyzing their T1, T2 relaxation times, proton density, and flow characteristics, with version 10.0 featuring software advancements such as DLR Clear and AutoPose to enhance image quality and streamline clinical workflow.

The ECHELON Synergy V10.0 is a Magnetic Resonance Imaging (MRI) system designed to provide physicians with non-invasive physiological and clinical information for diagnostic purposes. It operates by utilizing a 1.5 Tesla superconducting magnet to generate images based on the magnetic resonance of protons (hydrogen nuclei); the system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images of the head, body, spine, and extremities, reflecting the spatial distribution of protons and their NMR properties such as proton density, T1 and T2 relaxation times, and flow, with diagnostic uses including T1, T2, and proton density weighted imaging, diffusion-weighted imaging (DWI), MR Angiography, image processing, spectroscopy, and whole-body imaging. The V10.0 iteration introduces new features such as a camera unit for Synergy Vision and Visual StillShot, an alternative superconducting magnet, and updated V10.0A application software; performance evaluations demonstrated significant enhancements, particularly from the Deep Learning Reconstruction (DLR) Clear feature, which phantom and clinical studies (involving 53 subjects and 169 images) showed reduces truncation artifacts, improves image sharpness, and enhances spatial resolution, rendering clinically acceptable images often superior to conventional methods, and from the AutoPose applications for spine, breast, and hip joint imaging, which radiological technologists found to reduce the time and number of steps required for slice positioning in most of over 300 evaluated cases.

AI Regulatory Concerns

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• Q1. How does the performance of the 'alternative super-conducting magnet' in the ECHELON Synergy V10.0 compare to the predicate device's magnet in terms of image consistency, signal-to-noise ratio, and long-term operational stability?; What are the specific deep learning model architectures and training datasets utilized for the 'DLR Clear' feature, and what is its validated performance across a broader range of rare pathologies or patient demographics not extensively covered in the reported 53 subjects?; Can the efficiency gains from the 'AutoPose' feature for spine, breast, and hip joint be quantified in terms of average scan time reduction per patient, and what are its limitations when dealing with significant anatomical variations or post-operative patients?; What are the technical specifications of the newly added camera unit for 'Synergy Vision' and 'Visual StillShot', how do these features integrate into the MRI workflow, and what specific clinical scenarios do they aim to improve?; Beyond the described improvements in image sharpness and artifact reduction, does the 'DLR Clear' technology demonstrate any measurable benefits for quantitative MRI applications, such as the accuracy and reproducibility of T1/T2 mapping or diffusion metrics?