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510(k) Data Aggregation

    K Number
    K030962
    Device Name
    DPX SERIES BRAVO DUO BONE DENSITOMETER
    Manufacturer
    GE LUNAR CORP.
    Date Cleared
    2003-07-25

    (120 days)

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

    GE LUNAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DPX Series Bravo, Duo Bone Densitometer provides an estimate of BMD at the spine, proximal femur and forearm regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table. The use of the DPX Series Bravo, Duo Bone Densitometer is restricted to prescription use only.
    Device Description
    The DPX series Bravo, Duo Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm²) of the spine, femur and forearm. This BMD value can then be compared to a reference population at the sole discretion of the physician. The DPX Duo has mechanical features to allow use as an exam table when bone densitometry is disabled and the scan arm is rotated and locked parallel to the table.
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    K Number
    K023554
    Device Name
    DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
    Manufacturer
    GE LUNAR CORP.
    Date Cleared
    2002-12-20

    (58 days)

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

    GE LUNAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dual-energy Vertebral Assessment View Software is used with the Prodigy bone densitometer. This software provides an x-ray image of the spine for qualitative visual assessment in order to identify vertebral deformations and estimate vertebral heights (morphometry). The use of the Prodigy Bone Densitometer is restricted to prescription use only. The operator's manual for the Prodigy contains the following statement: "United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
    Device Description
    The Dual-energy Vertebral Assessment View Software enables imaging of the spine for visual identification of vertebral deformities and estimation of vertebral heights (morphometry). Using this software, the patient is scanned as under the currently distributed product. The Dual-energy Vertebral Assessment View Option adds the ability to visually assess the image for identification of vertebral deformations.
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    K Number
    K011917
    Device Name
    ADVANCED HIP ASSESSMENT SOFTWARE
    Manufacturer
    GE LUNAR CORP.
    Date Cleared
    2001-08-03

    (44 days)

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

    GE LUNAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hip Morphometry Software option is used on a typical dual-energy x-ray absorptiometry (DEXA) image of a femur from a Prodigy bone densitometer. This software provides a measurement of the hip axis length (HAL) and a mean value of HAL for Caucasian females.
    Device Description
    The Hip Morphometry Software, to be marketed as Advanced Hip Assessment Software, analyzes previously acquired dual-energy x-ray absorptiometry (DEXA) images of the proximal femur from the Prodigy bone densitometer for measurement of the hip axis length (HAL). The patient is scanned for bone density of the proximal femur with the currently distributed product, and puterit is bounded for official ware measures the HAL. A mean value of HAL for Caucasian females is included for comparison at the sole discretion of a physician.
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