BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    QuantumCam

    K Number: K161674 · Decision Oct 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    2
    Review Days
    126

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    Basic Information

    Device Name
    QuantumCam
    K Number
    K161674
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ddd-Diagnostic A/S
    Date Received
    June 16, 2016
    Decision Date
    October 20, 2016
    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 Ddd-Diagnostic A/S

    K Number Device Name
    K140206 SCINTILLATION GAMMA CAMERA