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

    SXT-60F/60M MOBILE C ARM X-RAY UNIT

    K Number: K896387 · Decision Feb 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    146
    Review Days
    109

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    Basic Information

    Device Name
    SXT-60F/60M MOBILE C ARM X-RAY UNIT
    K Number
    K896387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Toshiba America Medical Systems, In.C
    Date Received
    November 6, 1989
    Decision Date
    February 23, 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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