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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    1.5T 24E Posterior Array

    K Number: K223203 · Decision Mar 2, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    12
    Review Days
    139

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    Basic Information

    Device Name
    1.5T 24E Posterior Array
    K Number
    K223203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen RF Tech Co., Ltd.
    Date Received
    October 14, 2022
    Decision Date
    March 2, 2023
    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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