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510(k) Data Aggregation
(229 days)
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.
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.
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