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510(k) Data Aggregation

    K Number
    K981553
    Device Name
    AUTOMATED MEDICAL REPORT WRITER
    Manufacturer
    WOODSON AND ASSOCIATES, LLC.
    Date Cleared
    1998-09-29

    (151 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    WOODSON AND ASSOCIATES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Oasis 4.0 is an automated Medical Report Writer intended to be used with the Sahara Bone Sonometer to help communicate the results of the test in a uniform, accurate, and consistent manner. The results are expressed as QUI (Quantitative Ultrasound Index), estimated bone mineral density (BMD), T-score, and Z-score. The estimated BMD is calculated from the QUI. The results are also translated into one of the diagnostic categories - Normal, Osteopenia, or Osteoporosis - based upon the WHO criteria and the normative reference data base. There is standardized language for the estimated risk of fracture and for the therapeutic options which the attending physician may recommend.
    Device Description
    Oasis 4.0 Automated Medical Report Writer
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