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

    VirtuOst

    K Number: K220402 · Decision May 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    2
    Review Days
    462

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    Basic Information

    Device Name
    VirtuOst
    K Number
    K220402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    O.N. Diagnostics
    Date Received
    February 11, 2022
    Decision Date
    May 19, 2023
    Product Code
    KGI
    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
    KGI Densitometer, Bone

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    Other Clearances by O.N. Diagnostics

    K Number Device Name
    K113725 VIRTUOST