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510(k) Data Aggregation

    K Number
    K113286
    Device Name
    ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
    Manufacturer
    GE MEDICAL SYSTEMS LUNAR
    Date Cleared
    2012-04-27

    (172 days)

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

    GE MEDICAL SYSTEMS LUNAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GE Lunar enCORE software used on the GE Lunar bone densitometer total body scan estimates the Resting Metabolic Rate (RMR) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends. The GE Lunar enCORE software used on the GE Lunar bone densitometer total body scan estimates the Relative Skeletal Muscle Index (RSMI) in the male or female population age 18 and older. The data can be displayed in user-defined statistical formats and trends. The MirrorImage function in the enCORE software used on the GF. Lunar DXA bone densitometers can be used to estimate the total body composition and bone mineral density (BMD) when regions of the body are outside of the scan window by using scanned data from the corresponding region(s) on the opposite half of the body.
    Device Description
    enCORE is the software is used by the series of GE Lunar DXA bone densitometers. Release 14 of the enCORE software (enCORE 14 or enCORE 14.xx) includes some feature enhancements. The software will calculate Resting Metabolic Rate (RMR) and Resting Skeletal Muscle Index (RSMI) using existing scan data. The calculations of RMR and RSMI do not require any changes to the bone densitometer nor does it require additional scanning or radiation exposure beyond the Total Body scans. Additionally, the enCORE software can utilize a MirrorImage function, which estimates Body Composition values using scanned data from the opposite side of the body if the patient does not fit entirely within the scan window. The GE Lunar DXA bone densitometers measure the bone mineral density (BMD), lean and fat tissue mass and calculate derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI).
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    K Number
    K071570
    Device Name
    GE LUNAR BODY COMPOSITION SOFTWARE
    Manufacturer
    GE MEDICAL SYSTEMS LUNAR
    Date Cleared
    2007-06-27

    (19 days)

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

    GE MEDICAL SYSTEMS LUNAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GE Lunar Body Composition Software option (body composition) used on GE Lunar DEXA bone densitometer scans measures the regional and whole body bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional. These body composition values 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 GE Lunar Body Composition Software 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 body composition values are useful include nutritional disorders, overweight, obesity, weight management, eating disorders, anorexia nervosa, wasting syndrome, sarcopenia , gastrointestinal disorders, Crohn's disease, celiac disease, gastrectomy, hepatobiliary disorders, cirrhosis, gallstones, renal disorders, chronic renal failure, hemodialysis, organ transplantation, endocrinological disorders, hypopituitarism, acromegaly, Cushing's syndrome, growth hormone deficiency, bone disorders, osteoporosis, Paget's disease, osteopetrosis, pulmonary diseases, cystic fibrosis, chronic pulmonary obstructive disease (COPD), cardiovascular disease, corticosteroids therapy, hormone therapy, total parenteral nutrition (TPN), diabetes, AIDS(HIV. sympathetic dystrophy syndrome, amiotrophic lateral sclerosis, tetraplegy, Duchenn's muscular dystrophy, spinal cord injury complication. DEXA body composition is a useful alternative to hydrostatic weighing, skin fold measurements and bio-impedance estimates.
    Device Description
    The Body Composition Software Option for GE Lunar DEXA Bone Densitometers measures the bone mineral density (BMD), lean and fat tissue mass and calculates derivative values of bone mineral content (BMC), area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional/total soft tissue mass ratio, % fat, region % fat, total body % fat, Android % fat, Gynoid % fat, Android/Gynoid ratio (A/G ratio) and Body Mass Index (BMI). The values can be displayed in user-defined statistical formats and trends with color image mapping and compared to reference populations at the sole discretion of the health care professional. The software does not require any changes to the bone densitometer nor does it require additional scanning or radiation exposure beyond the bone density scans.
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