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

    XMA 325 (X-RAY GENERATOR)

    K Number: K850117 · Decision Apr 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    162
    Applicant Total
    6
    Review Days
    85

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    Basic Information

    Device Name
    XMA 325 (X-RAY GENERATOR)
    K Number
    K850117
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Summit Industries, Inc.
    Date Received
    January 14, 1985
    Decision Date
    April 9, 1985
    Product Code
    IZO
    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
    IZO Generator, High-Voltage, 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
    K850198 FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG
    K850118 XMA INTEGRATED TABLE