BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Tester, Acoustic, Bone Quality

    PMA: P990039 · Decision Aug 1, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Tester, Acoustic, Bone Quality
    Trade Name
    QUS-2 (TM) CALCANEAL ULTRASONOMETER
    PMA Number
    P990039
    Device Class
    FDA Class 3
    Product Code
    NAN
    Generic Name
    Tester, acoustic, bone quality
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    August 1, 2000
    Date Received
    July 14, 1999
    Expedited Review
    N
    Docket Number
    00M-1437

    Advisory Committee Statement

    APPROVAL FOR THE QUS-2 CALCANEAL ULTRASONOMETER. THE QUS-2 ULTRASONOMETER IS A MEDICAL DEVICE THAT UTILIZES QUANTITATIVE ULTRASOUND FOR EVALUATION OF THE CALCANEUS. ITS BUA (BROADBAND ULTRASOUND ATTENUATION) VALUE IS INTENDED TO BE USED AS AN AID IN THE DIAGNOSIS OF OSTEOPOROSIS AND IN THE DETERMINATION OF RISK OF SUBSEQUENT ATRAUMATIC FRACTURE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NAN Tester, Acoustic, Bone Quality