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

    LASERNET IMAGE MANAGER/PRINT SERVER

    K Number: K952485 · Decision Nov 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    60
    Applicant Total
    5
    Review Days
    178

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    Basic Information

    Device Name
    LASERNET IMAGE MANAGER/PRINT SERVER
    K Number
    K952485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2030
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Frantz Imaging, Inc.
    Date Received
    May 30, 1995
    Decision Date
    November 24, 1995
    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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