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

    XCT 2000 L PQCT BONE DENSITOMETER

    K Number: K983273 · Decision Oct 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    2
    Review Days
    42

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    Basic Information

    Device Name
    XCT 2000 L PQCT BONE DENSITOMETER
    K Number
    K983273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Systems, Inc.
    Date Received
    September 17, 1998
    Decision Date
    October 29, 1998
    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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