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510(k) Data Aggregation

    K Number
    K250318
    Device Name
    Planmed XFI
    Manufacturer
    Planmed Oy
    Date Cleared
    2025-09-26

    (234 days)

    Product Code
    SFV
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K220664
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Planmed XFI is intended to be used for cone beam computed tomography imaging of anatomies within sections of the spine, of upper extremities including shoulder(s), hand, relative joints (shoulder(s), elbow, wrist) and of lower extremities including hip(s), foot and feet, and relative joints (hip(s), knee(s), ankle(s)).

    The device is to be managed and operated/used in a professional healthcare environment by healthcare professionals and other legally qualified professionals only.

    Device Description

    The Planmed XFI X-ray unit utilizes cone beam computed tomography (CBCT) to generate three dimensional images. In CBCT imaging, a cylindrical volume of data is acquired in a single imaging procedure. This data comprises several hundred 2D images taken from various angles to encompass a specific pre-programmed target area. These images are subsequently employed for 3D reconstruction, accomplished through a dedicated PC equipped with reconstruction algorithms. The resulting reconstructed images can be visualized in three dimensions using a separate PC workstation equipped with suitable image viewer software.

    AI/ML Overview

    N/A

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