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ECHELON Synergy V10.0

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233687

by FUJIFILM Healthcare Americas Corporation

Identifiers

510(k) Number
K233687 FDA 510(k)
FDA Product Code
LNH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ECHELON Synergy V10.0 is a magnetic-resonance diagnostic system that provides non-ionizing physiological and clinical information through transverse, coronal, sagittal, oblique, and curved imaging planes. It is classified as a System, Nuclear Magnetic Resonance Imaging under FDA device classification and has been determined to be substantially equivalent via the traditional 510(k) pathway.

The device is manufactured by FUJIFILM Healthcare Americas Corporation and received FDA 510(k) clearance under K233687 on May 3, 2024. It is intended for use in radiology settings and is associated with multiple facility establishment identifiers and registration numbers as specified in the openFDA data.

Frequently asked questions

What is the ECHELON Synergy V10.0 used for?

The ECHELON Synergy V10.0 is used for diagnostic imaging in radiology settings, providing non-ionizing physiological and clinical information through various imaging planes.

Is the ECHELON Synergy V10.0 a single-use device?

The device data does not specify if the ECHELON Synergy V10.0 is single-use or reusable, but it is classified as a System, Nuclear Magnetic Resonance Imaging under FDA device classification.

What is the regulatory status of the ECHELON Synergy V10.0?

The ECHELON Synergy V10.0 received FDA 510(k) clearance under K233687 on May 3, 2024, and is classified as substantially equivalent via the traditional 510(k) pathway.

What type of facility can use the ECHELON Synergy V10.0?

The ECHELON Synergy V10.0 is intended for use in radiology settings and is associated with multiple facility establishment identifiers and registration numbers.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Echelon Synergy - FUJIFILM Healthcare Americas Corporation, Fujifilm Launches New ECHELON Synergy 1.5T MRI System Software with AI ..., ECHELON Synergy V10.0 | Fujifilm Healthcare Americas Corporation ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
FUJIFILM Healthcare Americas Corporation

Sources (1)

  • FDA 510(k) K233687 24 fields · synced Oct 6, 2026