BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Axial3D Insight

    K Number: K232841 · Decision Nov 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    303
    Applicant Total
    5
    Review Days
    62

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    Basic Information

    Device Name
    Axial3D Insight
    K Number
    K232841
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axial Medical Printing Limited
    Date Received
    September 14, 2023
    Decision Date
    November 15, 2023
    Product Code
    QIH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QIH Automated Radiological Image Processing Software

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    Other Clearances by Axial Medical Printing Limited

    K Number Device Name
    K250369 Axial3D Insight
    K231607 Axial3D Cloud Segmentation Service
    K222745 Axial3D Insight
    K221511 Axial3D Cloud Segmentation Service