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

    PC/QCT QUANTITATIVE SOFTWARE

    K Number: K896677 · Decision Jan 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    PC/QCT QUANTITATIVE SOFTWARE
    K Number
    K896677
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    The Institute For Radiological Image Sciences, Inc.
    Date Received
    November 27, 1989
    Decision Date
    January 23, 1990
    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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