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510(k) Data Aggregation

    K Number
    K993176
    Device Name
    MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
    Date Cleared
    2000-06-20

    (272 days)

    Product Code
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORLAND MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The bone density estimates from the pDEXATN and Discovery™ Bone Densitometers can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than agerelated bone loss. T-Score, % Young Reference, Z-Score, % Age Matched, and long and short term change values are provided. These reference populations include Caucasian, Afro-American, Hispanic, and Asian men and women. The bone density estimates from the pDEXA™ and Discovery™ bone densitometers can be used as an aid to physicians in determining fracture risk.
    Device Description
    In general, the Multi-Racial Reference Population capability for the pDEXA and Discovery bone densitometers compares the pDEXA and Discovery scan results to average values for people without bone related disease, who have the same gender and ethnic background as the patient. Its purpose is to aid the physician in determining the presence of bone disease other than age related bone loss. Both age matched and young reference comparisons are made. T-Score, Z-Score, % Young Reference, % Age Matched, and a graphical representation are presented. The Norland pDEXA and Discovery bone densitometers scan the forearm using the industry standard DXA pencil beam technology to assess bone density of the distal and proximal radius plus ulna sites. The Discovery is a newer, smaller version of the pDEXA with faster scan speeds and lower dose. The Discovery dose is < 1 mRem and the pDEXA is < 3 mRem. Discovery scan time is about 90 seconds and the pDEXA about 3 minutes. This reference population also includes Fracture Risk Assessment based on the World Health Organization (WHO) criteria. In general, this means that patients with T- Scores between 1 to -1 are considered to have a low risk of fracture; with T-Scores from -1 to -2.5 are considered to have a medium risk of fracture; and T-Scores below -2.5 are considered to have a high risk of fracture.
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    K Number
    K993337
    Device Name
    APOLLO MULTI-RACIAL REFERENCE POPULATION
    Date Cleared
    2000-05-16

    (224 days)

    Product Code
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORLAND MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The bone density estimates from the Apollo™ bone densitometer can be compared to gender and ethnic matched reference populations as an aid in determining the presence of bone disease other than age-related bone loss. T-Score, % Young Reference, Z-Score, % Age Matched, and long and short term change values are provided. These reference populations include Caucasian, Afro-American, Hispanic, and Asian men and women. The Apollo bone density estimates can be used as an aid to physicians in determining fracture risk.
    Device Description
    The Apollo™ Multi-Racial Reference Population capability compares patient values to average values for people without bone related disease, who have the same gender and ethnic background as the patient. Its purpose is to aid the physician in determining the presence of bone disease other than age related bone loss. Both age matched and young reference comparisons are made. T-Score, Z-Score, % Young Reference, % Age Matched, and a graphical representation are presented. This reference population also includes Fracture Risk assessment based on the World Health Organization (WHO) criteria. In general, this means that patients with T- Scores between +1 to -1 are considered to be normal with a low risk of fracture. Patients with T-Scores from -1 to -2.5 have low bone mass and an increased risk of fracture. Likewise, patients with T- Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. The Apollo™ scans the heel using the industry standard DXA pencil beam technology to assess bone density of the Os Calcis. A water bath is NOT used; and gels are not necessary. The dose to the patient is 0.2 mRem and the scatter/leakage radiation is <0.1 mRem/hour at 3 feet.
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    K Number
    K992125
    Device Name
    XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
    Date Cleared
    1999-11-22

    (152 days)

    Product Code
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORLAND MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other user selectable sites. It provides BMD (g/cm2), Area (cm2), and BMC (g) values. It compares these values to gender and ethnic matched reference populations and provides T-Score and % Young Reference, Z-Score and % age matched, and long term and short term change values. This includes sBMD (mg/cm2). The XR 46 performs soft tissue assessment and provides lean mass, fat mass, percent fat, and total soft tissue values for all scan sites, including Whole Body. The XR 46 includes a Report Writer that allows the operator to customize the appearance of their reports and to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their reports for each of these ranges. The bone density measurements from the XR 46 can be used as an aid to physicians in determining fracture risk.
    Device Description
    The XR 46 is a full featured, pencil beam, DXA, table bone densitometer that scans the Hip, Spine, Forearm, Whole Body, and other user selectable sites. It provides values for BMD, BMC, and Area. It trends follow-up scan values to provide long and short term % change. It also provides sideby-side comparison images and angulated cursors. The XR 46 compares patient values to gender and ethnic matched reference populations and provides T-Score, Z-Score, % Young Reference, and % Age Matched values. The XR 46 includes Fracture Risk assessment based on the World Health Organization (WHO) criteria. In general, this means that patients with T-Scores above -1 are considered to be normal; with T-Scores from -1 to -2.5 are considered to be osteopenic and have an increased risk of fracture; and T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. The XR 46 includes Body Composition assessment and provides lean, fat, and % fat values. It also provides hydrostatic weighing values based on the Siri and Brozek equations. The XR 46 includes a Report Writer that allows the operator to customize the appearance of their reports and to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their reports for each of these ranges.
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