BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    ECHELON Synergy MRI System

    K Number: K241429 · Decision Aug 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    ECHELON Synergy MRI System
    K Number
    K241429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Healthcare Corporation
    Date Received
    May 21, 2024
    Decision Date
    August 13, 2024
    Product Code
    LNH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNH System, Nuclear Magnetic Resonance Imaging

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    Other Clearances by Fujifilm Healthcare Corporation

    K Number Device Name
    K240571 OASIS MRI System
    K223426 ECHELON Synergy MRI system
    K221619 ECHELON Oval V6.2 MRI System
    K213829 SCENARIA View
    K220295 ARIETTA 50