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

    Smart Fit TorsoCardiac 1.5T

    K Number: K260519 · Decision Mar 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    17
    Review Days
    31

    Basic Information

    Device Name
    Smart Fit TorsoCardiac 1.5T
    K Number
    K260519
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Healthcare (Suzhou) Co., Ltd.
    Date Received
    February 17, 2026
    Decision Date
    March 20, 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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