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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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