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

    SIENET SPI SPOOLER

    K Number: K953552 · Decision Oct 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    141
    Applicant Total
    781
    Review Days
    88

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    Basic Information

    Device Name
    SIENET SPI SPOOLER
    K Number
    K953552
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.2020
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions USA, Inc.
    Date Received
    July 28, 1995
    Decision Date
    October 24, 1995
    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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