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

    SAMSUNG RAYPAX SYSTEM

    K Number: K991537 · Decision Jul 6, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    141
    Applicant Total
    6
    Review Days
    64

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    Basic Information

    Device Name
    SAMSUNG RAYPAX SYSTEM
    K Number
    K991537
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.2020
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Samsung Sds Co., Ltd.
    Date Received
    May 3, 1999
    Decision Date
    July 6, 1999
    Product Code
    LMD
    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
    LMD System, Digital Image Communications, Radiological

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