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

    Orthoscan Tau Mini C-Arm

    K Number: K213113 · Decision Oct 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    5
    Review Days
    24

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    Basic Information

    Device Name
    Orthoscan Tau Mini C-Arm
    K Number
    K213113
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthoscan, Inc.
    Date Received
    September 27, 2021
    Decision Date
    October 21, 2021
    Product Code
    OXO
    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
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

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    Other Clearances by Orthoscan, Inc.

    K Number Device Name
    K183220 OrthoScan TAU Mini C-Arm
    K133174 ORTHOSCAN FD MINI C-ARM
    K113708 ORTHOSCAN MOBILE DI MINI C-ARM
    K051754 ORTHOSCAN, ORTHOSCAN HD