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510(k) Data Aggregation

    K Number
    K143251
    Device Name
    SIGNA Creator, SIGNA Explorer
    Manufacturer
    GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC)
    Date Cleared
    2015-02-04

    (84 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by 1.5T SIGNA Creator and 1.5T SIGNA Explorer reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
    Device Description
    1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The 1.5T SIGNA Creator and 1.5T SIGNA Explorer features a superconducting magnet operating at 1.5 Tesla. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance. The data acquisition system accommodates 16 independent receive channels and multiple independent coil elements per channel during a single acquisition series.
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