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

    Bone Sonometer

    PMA: P010058 · Decision Mar 15, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Bone Sonometer
    Trade Name
    OSTEOSPACE
    PMA Number
    P010058
    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
    March 15, 2004
    Date Received
    October 3, 2001
    Expedited Review
    N
    Docket Number
    05M-0024

    Advisory Committee Statement

    APPROVAL FOR THE OSTEOSPACE. THE OSTEOSPACE IS A QUANTITATIVE ULTRASOUND BONE SONOMETER DEVICE (QUS) TO BE USED FOR THE MEASUREMENT OF BROADBAND ULTRASOUND ATTENUATION (BUA) OF THE CALCANEUS, AS AN AID, TOGETHER WITH OTHER CLINICAL RISK FACTORS, TO DIAGNOSE OSTEOPOROSIS AND OTHER MEDICAL CONDITIONS LEADING TO REDUCED BONE STRENGTH AND TO ESTIMATE THE RISK OF SUBSEQUENT ATRAUMATIC FRACTURE. THE OUTPUT IS EXPRESSED IN TERMS OF BUA, T-SCORE, AND Z-SCORE.

    Classifications

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

    Product Code Device Name
    MUA Bone Sonometer