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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, spinlattice relaxation time (TI), 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

The ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static maqnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varving the RF excitation. applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.

The provided document describes the Fujifilm ECHELON Synergy V10.0 MRI system, which is an updated version of a previously cleared device. The submission focuses on demonstrating substantial equivalence to the predicate device (ECHELON Synergy MRI System K223426) by highlighting changes and providing performance evaluations.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the overall device in a quantifiable format. Instead, it demonstrates the new features' performance through clinical image testing and phantom studies, comparing them to conventional methods or manual positioning. The acceptance criteria for "DLR Clear" are implied through achieving statistical significance for superiority in certain image quality metrics over conventional imaging and clinical acceptability. For "AutoPose," the criteria are implied through reduction or equivalence in time and steps for slice positioning.

Here's a summary of the performance results for the new features (DLR Clear and AutoPose):

• Truncation artifact reduction, image sharpness, and overall image quality in images with DLR Clear were superior to conventional images with **statistically significant difference (p

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