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The Orthoscan TAU MVP system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

The scope used with Orthoscan TAU MVP system is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.

The proposed Orthoscan TAU MVP (Multi Viewing Platform) Mini C-Arm system models 1000-0022, 1000-0023 retain identical function as the predicate Orthoscan TAU Mini C-Arm (K250587) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders and knees and hips. The system consists of C-Arm support attached to the image workstation.

The proposed Orthoscan TAU MVP Mini C-Arm system models 1000-0022, 1000-0023 represent a modification of our presently legally marketed devices Orthoscan TAU Mini C-Arm (K250587). The proposed Orthoscan TAU MVP Mini C-Arm System will consist of the Orthoscan TAU Mini C-Arm X-ray System with additional arthroscopic imaging capability to further standardize the product platform by incorporating components currently available in predicate devices into the Orthoscan TAU MVP system.

The proposed new Orthoscan TAU MVP system is a collaborative effort to display the fluoroscopic and arthroscopic image concurrently.

The proposed modifications to the predicate encompass the incorporation of hardware and software from MIDASVu arthroscopic imaging system reusable tablet (K243020) utilizing a modified mechanical design to incorporate a video processing unit imaging control board, umbilical cord and arthroscopic imaging system comprised of sterile, single-use scopes (K243020). The scopes include camera and image capture features with LED light source. The distal tip of the scopes contains the camera, illumination, and imaging optics. The scopes are available in three lengths: 60mm, 90mm, and 120mm. The scopes and the TAU MVP Mini C-Arm system work in concert as a system to acquire, display and record an intra-articular image as well as store images and video taken during the procedure.

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