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

    AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033

    K Number: K931883 · Decision Aug 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    82
    Applicant Total
    5
    Review Days
    131

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    Basic Information

    Device Name
    AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033
    K Number
    K931883
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alphatek Corp.
    Date Received
    April 14, 1993
    Decision Date
    August 23, 1993
    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 Alphatek Corp.

    K Number Device Name
    K023613 AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
    K931882 MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR
    K925569 AX-700LE AUTOMATIC X-RAY FILM PROCESSOR
    K924430 AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027