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

    G.E. DXD 325/350/350II/DXD 525/525II GENERATORS

    K Number: K902986 · Decision Feb 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    162
    Applicant Total
    11
    Review Days
    232

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    Basic Information

    Device Name
    G.E. DXD 325/350/350II/DXD 525/525II GENERATORS
    K Number
    K902986
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Electromek Diagnostic Systems, Inc.
    Date Received
    June 26, 1990
    Decision Date
    February 13, 1991
    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 Electromek Diagnostic Systems, Inc.

    K Number Device Name
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    K902988 G.E. MSI 850/850II/1250 THREE PHASE GENERATORS
    K902982 G.E. POLARIX II C-ARM
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    K902983 SIEMEN'S SIREMOBILE II C-ARM
    K902791 G.E. 48-4 CEILING TUBEHANGER
    K902989 G.E. MONITROL 90 AND G.E. MONITROL 15
    K902984 G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS
    K902980 G.E. XT CEILING TUBE SUSPENSION
    Search all 11 clearances from Electromek Diagnostic Systems, Inc. →