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The Orthoscan VERSA Mini C-arm X-ray 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 pediations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgency, traumatology, orthopedic, critical care, or physician office environments.

The proposed modifications to Ziehm-Orthoscan, Inc. VERSA Mini C-Arm series (which we will refer to internally and in this submittal as Orthoscan VERSA, for distinction from predicate Orthoscan TAU and Orthoscan Mobile DI) retain identical function as the predicate TAU Mini C-arm (K2131130) and predicate Mobile DI (K113708) 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. The system consists of C-arm support attached to the image workstation. The changes to the Orthoscan VERSA Mini C-arm X-ray system represent a modification of our presently legally marketed device Orthoscan TAU Mini C-Arm K213113 and Orthoscan Mobile DI Mini C-arm (K113708). The proposed modifications to the predicate encompass the implementation of a LINUX based operating system upgrade from Ubuntu version 16.04 to Ubuntu version 20.04 and related software revisions, modification to the mechanical design to further facilitate desk top use, revisions to generator printed circuit board to improve power management efficiency, implementation of an alternate generator radiation shielding material to reduce environmental impact of lead and an update to wireless footswitch communication protocol.

The Orthoscan TAU Mini C-arm 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 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 proposed modifications to Orthoscan, Inc. TAU Mini C-Arm series (which we will refer to internally and in this submittal as Orthoscan TAU 2.0, for distinction from predicate Orthoscan TAU) retain identical function as the predicate TAU Mini C-arm (K183220) 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, knees, and Hips. The system consists of C-arm support attached to the image workstation. The changes to the Orthoscan TAU series of Mini C-arm X-ray systems represent a modification of our presently legally marketed device Orthoscan TAU mini C-Arm K183220. The proposed modifications to the predicate encompass the implementation of an optional IGZO 15 cm x 15 cm Flat Panel Detector (FPD) in the 15x12cm and 15x15cm device detector sizes, a new LINUX based operating system and related software, image processing board revisions and a revised Power Manager Board for AC to DC conversion that will distribute 24Vdc via a medical grade DC power supply. The proposed device incorporates software architecture and other improvements that replicate the features and functions of the predicate device and improve image clarity without increasing dose levels.

The OrthoScan TAU Mini C-arm 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 pediatic populations when imaging limbs/extremittes, shoulders; at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

The OrthoScan TAU Mini C-Arm is a mobile fluoroscopic mini Carm 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, knees, and Hips. The system consists of C-arm support attached to the image workstation. The proposed device provides the option of three CMOS flat panel detector sizes and identical X-ray source HVPS monoblock generator assembly with continuous or pulsed operation for image acquisition. The C-arm supports the CMOS FPD, X-Ray controls, collimator, high voltage generator with a fixed SID imaging. The C-arm and support arm which is connected to the mobile workstation platform are mechanically balanced allowing the operator precise positioning and locking of the vertical, horizontal, orbital and rotational movements at various angles and distances when imaging the patient's anatomical structures. The main workstation platform that supports the C-arm assembly contains the power control system, image processing system, system software, monitor display control and main user interface controls. The combination of C-Arm and workstation provides the clinician with a stable platform to obtain precise angles for localizing the patient's anatomical structures and visualization of pathology during live fluoroscopic imaging. The touch screen interface and keyboard provide user concise selectable imaging, X-ray technique control, entry of patient demographics and related procedural information. The workstation supports both an optional wired or wireless fluoroscopic footswitch allowing optimal positioning for the clinician. The optional connector interface panel of the OrthoScan TAU Mini C-Arm provides convenient connection of peripheral devices such as thermal video printers, image storage devices (USB) and DICOM fixed wire and wireless network interfaces.

The OrthoScan Mobile DI Mini C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures in hospital, emergency care, critical care, or physician office environments.

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The OrthoScan mobile c-arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

The OrthoScan is a mini C-arm mobile imaging system. The OrthoScan is used for processing and capturing live fluoroscopic images. Interfaces are provided for external peripheral devices such as controls, thermal printers, video cassette recorders and DICOM. The device is compatible with NTSC video outputs and 100 Base T Ethernet.