BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Sonometer

    PMA: P970040 · Supplement: S001 · Decision Apr 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Bone Sonometer
    Trade Name
    ACHILLES EXPRESS ULTRASONOMETER
    PMA Number
    P970040
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    MUA
    Generic Name
    Bone sonometer
    Regulation Number
    892.1180
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 23, 1999
    Date Received
    February 16, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a design change that was primarily to replace the open water bath with water enclosed in silicone membranes. The device, as modified, will be marketed under the trade name Achilles Express and is indicated for: The Achilles Express ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by x-ray absorptiometry at the spine or hip.

    Classifications

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

    Product Code Device Name
    MUA Bone Sonometer