BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG

    K Number: K850198 · Decision May 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    116

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    Basic Information

    Device Name
    FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG
    K Number
    K850198
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1770
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Summit Industries, Inc.
    Date Received
    January 18, 1985
    Decision Date
    May 14, 1985
    Product Code
    IYB
    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
    IYB Tube Mount, X-Ray, Diagnostic

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    Other Clearances by Summit Industries, Inc.

    K Number Device Name
    K874908 C900 X-RAY FILM PROCESSOR
    K874687 COLLI-MATETM MODEL NO. B800
    K851440 RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR
    K850117 XMA 325 (X-RAY GENERATOR)
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