ECHELON Synergy MRI System

The ECHELON Synergy MRI System is a Magnetic Resonance Diagnostic Device designed to provide non-invasive physiological and clinical information through cross-sectional imaging for diagnostic aid. Its market approval stems from a substantial equivalence finding to a predicate device, with its core science based on producing images without ionizing radiation and its new Breast Coil 17 feature validated through rigorous performance evaluations.

A determination was issued on August 13, 2024, to FUJIFILM Healthcare Corporation concerning their ECHELON Synergy MRI System. This action allows the company to market the system, which is classified as a Magnetic Resonance Diagnostic Device. The ECHELON Synergy MRI System is intended to provide physicians with non-invasive physiological and clinical information by producing cross-sectional images of the head, body, or extremities, without using ionizing radiation, to aid in diagnosis. The review found the ECHELON Synergy MRI System to be substantially equivalent to a previously available predicate device, the ECHELON Synergy V10.0, for its specified indications for use. The primary modification in the new system is the addition of a Breast Coil 17, with no significant changes to its core hardware, software, or overall functionality. Performance evaluations, including bench and clinical testing, confirmed that the system, with its new feature, performs as intended and meets clinical usability standards while complying with relevant safety and performance benchmarks. Marketing of the system remains subject to general controls and ongoing requirements for manufacturing practices, labeling, and post-market safety reporting.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific clinical benefits does the addition of the Breast Coil 17 offer over previous versions for breast imaging?; How do the image quality and diagnostic accuracy of the ECHELON Synergy MRI System with the new Breast Coil 17 compare to other advanced breast MRI systems currently on the market?; Were there any specific challenges or limitations identified during the bench or clinical testing related to the new Breast Coil 17's performance or integration?; What are the long-term post-market surveillance plans for the ECHELON Synergy MRI System, particularly concerning the performance and safety of the new Breast Coil 17?; Does the ECHELON Synergy MRI System offer any unique pulse sequences or advanced imaging capabilities beyond standard cross-sectional imaging that enhance its diagnostic utility?