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

    C900 X-RAY FILM PROCESSOR

    K Number: K874908 · Decision Feb 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    82
    Applicant Total
    6
    Review Days
    73

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    Basic Information

    Device Name
    C900 X-RAY FILM PROCESSOR
    K Number
    K874908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Summit Industries, Inc.
    Date Received
    December 1, 1987
    Decision Date
    February 12, 1988
    Product Code
    IXW
    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
    IXW Processor, Radiographic-Film, Automatic

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    Other Clearances by Summit Industries, Inc.

    K Number Device Name
    K874687 COLLI-MATETM MODEL NO. B800
    K851440 RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR
    K850198 FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG
    K850117 XMA 325 (X-RAY GENERATOR)
    K850118 XMA INTEGRATED TABLE