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

    SECTRA OSTEOPOROSIS PACKAGE

    K Number: K021527 · Decision Jun 7, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    9
    Review Days
    28

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    Basic Information

    Device Name
    SECTRA OSTEOPOROSIS PACKAGE
    K Number
    K021527
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sectra-Imtec AB
    Date Received
    May 10, 2002
    Decision Date
    June 7, 2002
    Product Code
    KGI
    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
    KGI Densitometer, Bone

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    Other Clearances by Sectra-Imtec AB

    K Number Device Name
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    K031590 SECTRA ORTHOPEDIC PACKAGE
    K002936 MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM
    K983447 WISE (II) IMAGE MANAGEMENT SYSTEM
    K965161 SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
    K963395 IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
    K961983 TRS 2000 TELERADIOLOGY SYSTEM