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510(k) Data Aggregation

    K Number
    K222458
    Device Name
    AIBOLIT 3D+
    Date Cleared
    2023-01-12

    (150 days)

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

    Aibolit Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aibolit 3D+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT and MRI imaging devices. Aibolit 3D+ is intended as software for preoperative surgical planning, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
    Device Description
    Aibolit 3D+ is a web-based stand-alone application that can be presented on a computer connected to the internet. Once the enhanced images are created, they can be used by the physician for case review, patient education, professional training and intraoperative reference. Aibolit 3D+ is a software only device, which processes CT and MR images from a patient to create 3-dimensional images that may be manipulated to view the anatomy from virtually any perspective. The software also allows for transparent viewing of anatomical structures artifacts inside organs such as ducts, vessels, lesions and entrapped calcifications (stones). Anatomical structures are identified by name and differential coloration to highlight them within the region of interest. The software may help to facilitate the surgeon's decision-making during planning, review and conduct of surgical procedures and, hence, may potentially help them to decrease or prevent possible errors caused by the misidentification of anatomical structures and their positional relationship.
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    K Number
    K211443
    Device Name
    AIBOLIT 3D+
    Date Cleared
    2022-01-07

    (242 days)

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

    AIbolit Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aibolit 3D+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT imaging devices. Aibolit 3D+ is intended as software for preoperative surgical planning, training, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
    Device Description
    Aibolit 3D+ is a web-based stand-alone application that can be presented on a computer connected to the internet. Once the enhanced images are created, they can be used by the physician for case review, patient education, professional training and intraoperative reference. Aibolit 3D+ is a software only device, which processes CT images from a patient to create 3-dimensional images that may be manipulated to view the anatomy from virtually any perspective. The software also allows for transparent viewing of anatomical structures artifacts inside organs such as ducts, vessels, lesions and entrapped calcifications (stones). Anatomical structures are identified by name and differential coloration to highlight them within the region of interest. The software may help to facilitate the surgeon's decision-making during planning, review and conduct of surgical procedures and, hence, may potentially help them to decrease or prevent possible errors caused by the misidentification of anatomical structures and their positional relationship.
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    Ask a specific question about this device

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