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510(k) Data Aggregation

    K Number
    K980289
    Device Name
    FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER
    Manufacturer
    NORLAND CORP.
    Date Cleared
    1998-06-12

    (137 days)

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

    NORLAND CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bone density estimates from the SXA 3000™ can be used as an aid to physicians in determining fracture risk, based on their comparison to estimates for people without bone related disease, who have the same gender and ethnic background as the patient.
    Device Description
    The Norland OsteoAnalyzerTM Model SXA 3000TM X-Ray Bone Densitometer (SXA 3000TM) can be used whenever it is desirable to do a bone assessment of the os calcis (heel). Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynecology, etc. The SXA 3000TM scans the heel using the industry standard SXA pencil beam technology and provides BMC, Area, BMD, T-Score, and Z-Score values. A scan takes about three minutes and the patient dose is less than 1.5 mRem. The SXA 3000TM provides fracture risk assessment based on the World Health Organization (WHO) criteria for relating the bone density test to fracture risk assessment and disease diagnosis. In general, this assessment states that patients with T-Scores from +1 to -1 are considered to be normal; T-Scores from -1 to -2.5 are considered to have low bone mass and an increased risk of fracture; and T-Scores below -2.5 are considered to be osteoporotic with a high risk of fracture.
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    K Number
    K980569
    Device Name
    FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS
    Manufacturer
    NORLAND CORP.
    Date Cleared
    1998-06-12

    (119 days)

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

    NORLAND CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bone density estimates from Norland X-Ray Bone Densitometers can be used as an aid to the physician in determining risk of fracture.
    Device Description
    This fracture risk assessment capability provides information that aids the physician in determining risk of fracture, risk of bone disease, or treatment effectiveness. This fracture risk assessment capability interprets the results of the bone density tests performed by Norland bone densitometers in accordance with methods in general use in the medical community. In general they use the bone densitometer values (usually BMD and T-Score) and patient information (usually gender, age, and ethnic background). The interpretation is based on the World Health Organization's (WHO) criteria relating bone density to risk of fracture and diagnosis of osteoporosis. In general, the WHO criteria means that patients with T-Scores from +1 to -1 are considered to be normal; with T-Scores from -1 to -2.5 are considered to have low bone mass and have an increased risk of fracture; and with T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. This information is presented graphically and as verbiage on the screens and reports. This fracture risk capability does not require any modifications to the Norland bone densitometers besides adding the fracture risk information to the screens and printouts. In particular, it does not increase the scanning time, patient dose, or scatter radiation.
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    K Number
    K980125
    Device Name
    REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
    Manufacturer
    NORLAND CORP.
    Date Cleared
    1998-05-20

    (126 days)

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

    NORLAND CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bone density estimates from the Apollo™ can be compared to estimates of young normal Caucasian men and women, and as an aid to physicians in diagnosing and managing osteoporosis. The bone density estimates from the Apollo™ can be used as an aid to physicians in determining fracture risk.
    Device Description
    The Norland Apollo™ Bone Densitometer (Apollo™) scans the os calcis (heel) using the industry standard DXA pencil beam technology to assess bone density. A water bath is not required and the scan takes less than 30 seconds. Patient dose is less than 0.5 mRem and scatter radiation is less than 0.1 mRem/hour at 3 feet. Two reference sets are provided, one for female Caucasians and one for male Caucasians. These reference data sets allow comparison of Apollo™ BMD scan results to healthy young adults aged 20 to 42. The results of the comparison is given in terms of T-Score (the number of standard deviations from the healthy young adult value), % Young Reference (the percentage relative to the healthy young adult value), and in graphical form. The Apollo™ Reference Population capability also includes Fracture Risk assessment based on the World Health Organization (WHO) criteria. In general, this means that patients with T- Scores from +1 to -1 are considered to be normal; with T-Scores from -1 to -2.5 are considered to have low bone mass 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. Other reference data sets will be available in the future.
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    K Number
    K973459
    Device Name
    NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS
    Manufacturer
    NORLAND CORP.
    Date Cleared
    1998-02-13

    (154 days)

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

    NORLAND CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Norland Body Composition Option (body composition) assesses the non-bone tissue determined during the bone density scans performed by Norland DEXA bone densitometers, and estimates soft tissue mass, fat mass, lean mass, total soft tissue mass, % fat, TBMC/LBM (Total Bone Mineral Content / Lean Body Mass), and Siri and Brozek equation equivalent values. These body composition estimates are useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment, can affect the relative amounts of patient fat and lean tissue. The Norland Body Composition Option does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases/conditions for which lean and fat tissue estimates are useful are chronic renal failure, Anorexia Nervosa, excessive obesity, AIDS/HIV, and Cystic Fibrosis. Body composition is also a convenient alternative to hydrostatic weighing and skin fold measurements.
    Device Description
    The Norland Body Composition Option (body composition) is used with Norland DEXA bone densitometers to estimate the relative amounts of lean and fat tissue in the scan area. Body composition does not require any changes to the bone densitometer nor does it require additional scanning or radiation exposure beyond the bone density scans. In most cases, existing scans can be re-analyzed to provide the body composition values. Although body composition is most useful for whole body scans, it is compatible with all scan modes for Norland DEXA bone densitometers. Body composition values for whole body scans were compared to underwater weighing (UWW) values in clinical studies involving hundreds of subjects. The UWW values were determined using both the Siri and Brozek equations. Based on this study, the Norland body composition provides the Siri and Brozek equivalent values for the Whole Body scans.
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    K Number
    K973104
    Device Name
    NORLAND MODEL PDEXA BONE DENSITOMETER
    Manufacturer
    NORLAND CORP.
    Date Cleared
    1998-01-29

    (163 days)

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

    NORLAND CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bone density estimates from the Norland pDEXA™ Bone Densitometer can be used as an aid to the physician in determining fracture risk.
    Device Description
    The Fracture Risk Option consists of updated software which adds the fracture risk features to the screens and printed reports for the pDEXA. It also includes a supplement to the pDEXA Operator's Guide which explains how to interpret the pDEXA bone density values to aid in the assessment of fracture risk and the diagnosis of osteoporosis.
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    K Number
    K972882
    Device Name
    APOLLO
    Manufacturer
    NORLAND CORP.
    Date Cleared
    1997-10-31

    (87 days)

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

    NORLAND CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apollo can be used whenever it is desirable to do a bone assessment of the heel. Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynocology, etc. The Apollo assesses the heel and provides BMC, Area, and BMD. It compares a scan to previous scans of the same subject and provides Long Term % Change and Short Term % change. It also provides user selectable modes which trade off scan speed for precision.
    Device Description
    Apollo™ is a low cost, portable, easy-to-use bone densitometer which uses low dose x-ray technology to asses the bone density of the heel. Because Apollo 1 uses the DXA technique, a water bath is not required.
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