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510(k) Data Aggregation

    K Number
    K223523
    Device Name
    Sonic DL
    Manufacturer
    GE Medical Systems,LLC (GE Healthcare)
    Date Cleared
    2023-05-30

    (188 days)

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

    GE Medical Systems,LLC (GE Healthcare)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sonic DL is a Deep Learning based image reconstruction technique that is available for use on GE Healthcare 1.5T and 3.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions. Sonic DL is intended for cardiac imaging, and for patients of all ages.
    Device Description
    Sonic DL is a new software feature intended for use with GE Healthcare MR systems. It consists of a deep learning based reconstruction algorithm that is applied to data from MR cardiac cine exams obtained using a highly accelerated acquisition technique. Sonic DL is an optional feature that is integrated into the MR system software and activated through a purchasable software option key.
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    K Number
    K213717
    Device Name
    AIR Recon DL
    Manufacturer
    GE Medical Systems,LLC (GE Healthcare)
    Date Cleared
    2022-06-08

    (196 days)

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

    GE Medical Systems,LLC (GE Healthcare)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AIR Recon DL is a deep learning based reconstruction technique that is available for use on GE Healthcare 1.5T, 3.0T, and 7.0T MR systems. AIR Recon DL reduces noise and ringing (truncation artifacts) in MR images, which can be used to reduce scan time and improve image quality. AIR Recon DL is intended for use with all anatomies, and for patients of all ages. Depending on the anatomy of interest being imaged, contrast agents may be used.
    Device Description
    AIR Recon DL is a software feature intended for use with GE Healthcare MR systems. It is a deep learning based reconstruction technique that removes noise and ringing (truncation) artifacts from MR images. AIR Recon DL is an optional feature that is integrated into the MR system software and activated through a purchasable software option key.
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    K Number
    K213715
    Device Name
    Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition
    Manufacturer
    GE Medical Systems,LLC
    Date Cleared
    2021-12-17

    (23 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical Systems,LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The systems with 160 mm detector coverage have the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy. If the spectral imaging option is included on the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures. GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus nonuric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.
    Device Description
    The Revolution CT family of products, including Revolution CT, Revolution CT ES, Revolution CT with Apex edition, Revolution CT ES with Apex edition Apex, Revolution Apex Elite, Revolution Apex Plus, and Revolution Apex Select, Revolution CT Power, Revolution Apex Pro are multi-slice CT scanners consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. GE has modified the cleared Revolution CT (K19177) within our design controls to include the 0.23 s/rot option. The 0.23s/rot option can be used with axial scan acquisitions and is especially beneficial during certain cardiac scan acquisitions. The scan workflow and user interface remain identical to the of the predicate device, with the exception that the user now has the option to select 0.23 s/rot in addition to other gantry rotation speeds. The addition of a new maximum gantry rotation speed leads to updates to system performance claims about maximum temporal resolution when combined with the optional Snapshot Freeze 2 (K183161) feature.
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    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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