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

    MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT

    K Number: K900193 · Decision May 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    5
    Review Days
    113

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    Basic Information

    Device Name
    MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT
    K Number
    K900193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Imt America, Inc.
    Date Received
    January 16, 1990
    Decision Date
    May 9, 1990
    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 Imt America, Inc.

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    K903422 MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE
    K900194 MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT