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510(k) Data Aggregation

    K Number
    K213603
    Device Name
    SIGNA Artist Evo
    Manufacturer
    GE Healthcare(Tianjin) Company Limited
    Date Cleared
    2022-02-11

    (88 days)

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

    GE Healthcare(Tianjin) Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SIGNA™ Artist Evo system is a whole body magnetic resonance scanner designed to support 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, neart, 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 the SIGNA™ Artist Evo system reflect the spatial distribution or molecular environment of nuclej exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
    Device Description
    The SIGNA™ Artist Evo system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The system features a superconducting magnet. The data acquisition system accommodates up to 128 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms.
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    K Number
    K192426
    Device Name
    Signa Voyager, Signa Voyager Quantum
    Manufacturer
    GE Healthcare(Tianjin) Company Limited
    Date Cleared
    2019-10-01

    (26 days)

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

    GE Healthcare(Tianjin) Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SIGNA Voyager is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time imaging. The SIGNA Voyager is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body. Body structures for evaluation include, but are 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 the SIGNA Voyager reflect the spatial distribution and/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
    The SIGNA Voyager system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial and oblique planes, using various pulse sequences and reconstruction algorithms. The system is offered as a new system installation, in either a fixed or a mobile configuration. The system features a 1.5T superconducting magnet with a 70cm bore size.
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