BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U

    K Number: K043293 · Decision Dec 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    2
    Review Days
    18

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    Basic Information

    Device Name
    MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U
    K Number
    K043293
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acrorad Co., Ltd.
    Date Received
    November 29, 2004
    Decision Date
    December 17, 2004
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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    Other Clearances by Acrorad Co., Ltd.

    K Number Device Name
    K040587 MINI GAMMA CAMERA, MODEL MGC-500