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

    DIGITAL IMAGE SCANNER, MODEL DIS-1000

    K Number: K901423 · Decision Apr 30, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    60
    Applicant Total
    7
    Review Days
    35

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    Basic Information

    Device Name
    DIGITAL IMAGE SCANNER, MODEL DIS-1000
    K Number
    K901423
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2030
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Lumisys, Inc.
    Date Received
    March 26, 1990
    Decision Date
    April 30, 1990
    Product Code
    LMA
    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
    LMA Digitizer, Image, Radiological

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