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510(k) Data Aggregation

    K Number
    K231607
    Device Name
    Axial3D Cloud Segmentation Service
    Date Cleared
    2024-01-24

    (237 days)

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

    Axial Medical Printing Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Axial3D Cloud Segmentation Service is intended for use as a cloud-based service and image segmentation Framework for the transfer of DICOM imaging information from a medical scanner to an output file, which can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning and/or diagnostic purposes in the field of orthopedic, maxillofacial, and cardiovascular applications in adults. The or physical replica may also be used for pediatrics between the ages of 12 and 21 years of age in cardiovascular applications. Axial3D Cloud Segmentation Service should be used with other diagnostic tools and expert clinical judgment.
    Device Description
    Axial3D Cloud Segmentation Service is a secure, highly available cloud-based image processing, segmentation, and 3D modelling framework for the transfer of imaging information either as a digital file or as a 3D printed physical model.
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    K Number
    K232841
    Device Name
    Axial3D Insight
    Date Cleared
    2023-11-15

    (62 days)

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

    Axial Medical Printing Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Axial3D Insight is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3D Insight output file can be used for the fabrication of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The output file or physical replica can be used for diagnostic purposes in the field of trauma, orthopedic, maxillofacial, and cardiovascular applications. Axial3D Insight should be used with other diagnostic tools and expert clinical judgment.
    Device Description
    Axial3D Insight is a secure, highly available cloud-based image processing, segmentation, and 3D modelling framework for the transfer of imaging information either as a 3D printed physical model.
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    K Number
    K222745
    Device Name
    Axial3D Insight
    Date Cleared
    2023-07-03

    (294 days)

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

    Axial Medical Printing Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Axial3DInsight is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3DInsight output file can be used for the fabrication of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The output file or physical replica can be used for diagnostic purposes in the field of orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. Axial3DInsight should be used with other diagnostic tools and expert clinical judgment.
    Device Description
    Axial3D Insight is a secure, highly available cloud-based image processing, segmentation and 3D modelling framework for the transfer of imaging information either as a 3D printed physical model.
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    K Number
    K221511
    Device Name
    Axial3D Cloud Segmentation Service
    Date Cleared
    2022-06-23

    (30 days)

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

    Axial Medical Printing Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Axial3D Cloud Segmentation Service is intended for use as a cloud based service and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3D Cloud Segmentation Service output file can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Axial3D Cloud Segmentation Service should be used in conjunction with other diagnostic tools and expert clinical judgment.
    Device Description
    Axial3D Cloud Segmentation Service is a secure, highly available cloud based image processing, segmentation and 3D modeling framework for the transfer of imaging information to either a digital file or as a 3D printed physical model. Axial3D Cloud Segmentation Service is made up of a number of component parts, which allow the production of patient-specific 1:1 scale replica models, either as a digital file or as a 3D printed physical model.
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