BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    BoneView

    K Number: K222176 · Decision Mar 2, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    223

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    Basic Information

    Device Name
    BoneView
    K Number
    K222176
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2090
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gleamer
    Date Received
    July 22, 2022
    Decision Date
    March 2, 2023
    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 Gleamer

    K Number Device Name
    K212365 BoneView