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

    Smart Fit Knee 3.0T

    K Number: K233600 · Decision Feb 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    17
    Review Days
    88

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    Basic Information

    Device Name
    Smart Fit Knee 3.0T
    K Number
    K233600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Healthcare (Suzhou) Co., Ltd.
    Date Received
    November 9, 2023
    Decision Date
    February 5, 2024
    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 Philips Healthcare (Suzhou) Co., Ltd.

    K Number Device Name
    K252992 CT Rembra RT; CT Areta RT; CT Rembra
    K260519 Smart Fit TorsoCardiac 1.5T
    K242329 CT Collaboration Live
    K232491 CT 5300
    K232021 Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
    K223311 Philips CT 3500
    K212441 Philips Incisive CT
    K212864 dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
    K211168 Philips Incisive CT on Trailer
    K203514 Precise Position
    Search all 17 clearances from Philips Healthcare (Suzhou) Co., Ltd. →