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

    SECTRA WORKSTATION, VERSION 11.1

    K Number: K063093 · Decision Nov 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    SECTRA WORKSTATION, VERSION 11.1
    K Number
    K063093
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sectra Imtec AB
    Date Received
    October 10, 2006
    Decision Date
    November 7, 2006
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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    Other Clearances by Sectra Imtec AB

    K Number Device Name
    K110025 SECTRA MICRODOSE MAMMOGRAPHY
    K081469 SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2
    K051315 MODIFICATION TO: SECTRA IDS5 WORKSTATION
    K050196 SECTRA IDS5 WORKSTATION