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

    LEKSELL GAMMAPLAN (LGP)

    K Number: K914808 · Decision Jan 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    47
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    LEKSELL GAMMAPLAN (LGP)
    K Number
    K914808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elekta Instruments, Inc.
    Date Received
    October 25, 1991
    Decision Date
    January 23, 1992
    Product Code
    IWB
    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
    IWB System, Radiation Therapy, Radionuclide

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