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

    SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)

    K Number: K965161 · Decision Mar 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    141
    Applicant Total
    9
    Review Days
    79

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    Basic Information

    Device Name
    SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
    K Number
    K965161
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.2020
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sectra-Imtec AB
    Date Received
    December 23, 1996
    Decision Date
    March 12, 1997
    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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    Other Clearances by Sectra-Imtec AB

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