BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Bone Sonometer

    PMA: P980010 · Decision Sep 19, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Bone Sonometer
    Trade Name
    DTU-ONE ULTRASOUND SCANNER
    PMA Number
    P980010
    Device Class
    FDA Class 2
    Product Code
    MUA
    Generic Name
    Bone sonometer
    Regulation Number
    892.1180
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    September 19, 2000
    Date Received
    April 15, 1998
    Expedited Review
    N
    Docket Number
    00M-1615

    Advisory Committee Statement

    APPROVAL FOR THE DTU-ONE ULTRASOUND SCANNER. THE DTU-ONE IS INTENDED TO PERFORM QUANTITATIVE ULTRASOUND MEASUREMENT OF THE CALCANEUS (THE HEEL BONE), THE RESULTS OF WHICH CAN BE USED IN CONJUNCTION WITH OTHER CLINICAL RISK FACTORS AS AN AID TO THE PHYSICIAN IN DIAGNOSIS OF OSTEOPOROSIS (T-SCORE) AND IN THE DETERMINATION OF FRACTURE RISK IN MEN AND WOMEN. THE MEASUREMENT MAY ALSO BE USED IN CAUCASIAN WOMEN TO AID IN THE DETECTION OF MEDICAL CONDITIONS, OTHER THAN AGE-RELATED BONE LOSS, THAT LEAD TO REDUCED BONE DENSITY.

    Classifications

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

    Product Code Device Name
    MUA Bone Sonometer