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510(k) Data Aggregation

    K Number
    K111791
    Device Name
    LUMAGEM MOLECULAR BREAST IMAGING SYSTEM
    Manufacturer
    GAMMA MEDICA-IDEAS INCORPORATED
    Date Cleared
    2011-09-23

    (88 days)

    Product Code
    IYX
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAMMA MEDICA-IDEAS INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LumaGEM™ Molecular Breast Imaging System is intended to measure and image the distribution of radionuclides by means of photon detection in order to aid in the evaluation of lesions in the breast tissue and other small body parts. The LumaGEM™ Molecular Breast Imaging System, when used for breast imaging, is intended to serve as an adjunct to mammography or other primary breast imaging modalities. The LumaGEM™ Molecular Breast Imaging System is indicated for planar scintigraphy in the energy range of 30-300 keV for the detection and display of radioisotope tracer uptake in patients of all ages. The resultant images are intended to be viewed by qualified medical professionals.
    Device Description
    The LumaGEM™ Molecular Breast Imaging System is a scintillation camera system, which uses Cadmium Zinc Telluride (CZT) detectors to create an image of radionuclide distribution. The LumaGEM™ Molecular Breast Imaging System is available in a dualhead or single-head configuration and can be used to help identify suspected lesions in breast tissue as an adjunct to standard mammography. The LumaGEM™ Molecular Breast Imaging System is provided with a customized gantry, which allows flexible positioning to facilitate accurate breast imaging, and a workstation to enable image acquisition and analysis functions.
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    K Number
    K111731
    Device Name
    MOLECULAR BREAST IMAGING SOFTWARE
    Manufacturer
    GAMMA MEDICA-IDEAS INCORPORATED
    Date Cleared
    2011-09-15

    (87 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAMMA MEDICA-IDEAS INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Molecular Breast Imaging Software is designed to acquire nuclear medicine image data from the Gamma Medica-Ideas LumaGEM™ gamma camera systems. The Molecular Breast Imaging Software allows images and data to be stored, communicated, processed, analyzed and displayed on a compatible workstation.
    Device Description
    The Gamma Medica-Ideas Molecular Breast Imaging Software ("MBI Software") is a software tool intended to display and process breast images captured with the Gamma Medica-Ideas LumaGEM" gamma camera systems. The MBI Software contains functions of study display, Gray and Inverse Gray Images, Window/Level changes, Measuring Tool, image processing, and Save, Sum, and Reload (both raw and processed). Image processing is based on pixel-by-pixel analysis and algorithmic filters applications. The MBI Software application supports simultaneous display of multiple images, allowing the user to visualize several angles of the imaged breast tissue at once. The MBI Software is compatible with DICOM and other formats.
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    K Number
    K993813
    Device Name
    LUMAGEM SCINTILLATION CAMERA
    Manufacturer
    GAMMA MEDICA
    Date Cleared
    2000-01-18

    (69 days)

    Product Code
    IYX
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAMMA MEDICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LumaGEM™ scintillation camera is a gamma camera system, which is intended for measuring and imaging the distribution of radionuclides in the human body by means of photon detection. These images are intended to be interpreted by qualified medical personnel.
    Device Description
    The principles of operation and technology incorporated in the LumaGEM™ are equivalent to scintillation gamma cameras which use a combination of a scintillator with photomultiplier tubes as a photon radiation detector. The LumaGEM™ gamma camera includes signal analysis and display equipment, equipment supports and accessories.
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