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

    OsteoDetect

    K Number: DEN180005 · Decision May 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    9
    Applicant Total
    6
    Review Days
    108

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    Basic Information

    Device Name
    OsteoDetect
    K Number
    DEN180005
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.2090
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Imagen Technologies, Inc.
    Date Received
    February 5, 2018
    Decision Date
    May 24, 2018
    Product Code
    QBS
    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
    QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture

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    Other Clearances by Imagen Technologies, Inc.

    K Number Device Name
    K230085 Lung-CAD
    K223811 Lung-CAD
    K213353 Aorta-CAD
    K210666 Chest-CAD
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