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510(k) Data Aggregation

    K Number
    K251992

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-11

    (229 days)

    Product Code
    Regulation Number
    892.1650
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ArmSure Fluoroscopic Positioning System is a software-enabled manual Assist Arm intended for use with fluoroscopic systems to assist in the visualization of the spatial relationship of attached compatible surgical instruments and interventional accessories on X-ray images, and to maintain the corresponding spatial position to hold the attached instrument or accessory.

    The ArmSure system is intended to be used by trained healthcare professionals in a clinical environment, and is indicated for use during fluoroscopically-guided procedures involving the spine and long bones in patients whose anatomical size is suitable for the compatible instruments and the host fluoroscopic system.

    Device Description

    The ArmSure Fluoroscopic Positioning System combines a software application with an Assist Arm to provide real-time visualization of surgical instrument locations within X-ray images. The visualization is derived from data transmitted by the Assist Arm to the ArmSure software, which performs calculations based on image coordination to superimpose the instrument's position onto the fluoroscopic X-ray images.

    The Assist Arm is a manual, non-actuated device designed to be operated by the surgeon at the patient's side. The surgeon manually manipulates the Assist Arm in response to the interactive feedback displayed on the external screen, enabling precise instrument positioning through this real-time interface.

    AI/ML Overview

    N/A

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