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

    HD 8Ch Wrist Array

    K Number: K252587 · Decision Apr 14, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    12
    Review Days
    242

    Basic Information

    Device Name
    HD 8Ch Wrist Array
    K Number
    K252587
    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
    August 15, 2025
    Decision Date
    April 14, 2026
    Product Code
    MOS
    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
    MOS Coil, Magnetic Resonance, Specialty

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    Other Clearances by Shenzhen RF Tech Co., Ltd.

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    K200836 8ch Flex Suite
    K172222 8ch Flex Suite
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