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The Veran SPIN VisionTM Single-Use Flexible Bronchoscope is intended to be used with the SPiN Vision™ Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Veran SPiN Vision™ Single-Use Flexible Bronchoscopes and SPiN Vision™ Video Processor are for use in hospitals, clinics, and/or urgent care centers by trained physicians.

The Veran SPiN Vision™ Bronchoscope System consists of the Veran SPiN Vision™ Single-Use Flexible Video Bronchoscope accessories (Model Nos. INS-7100 and INS-7130) and the Veran SPiN Vision™ Video Processor (Model: SYS-5100) for clinical image processing. The Veran SPiN Vision™ Single-Use Flexible Bronchoscope is introduced within the airways or tracheobronchial tree during Bronchoscopy. The Veran SPiN Vision™ Video Processor provides power and processes the images for medical electronic endoscope. The Veran SPiN Vision™ Single-use Flexible Video Bronchoscope is a sterile, single use flexible bronchoscope. The Veran SPiN Vision™ Video Processor is a reusable device. The light emitted by the LED cold light source of the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Veran SPiN Vision™ Video Processor via the encoding circuit. The Veran SPiN Vision™ Video Processor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal. The Veran SPiN Vision™ Single-use Flexible Video Bronchoscope has the following physical and performance characteristics: - Maneuverable tip controlled by the user - Flexible insertion cord - Camera and LED light source at the distal tip - Working channel - Sterilized by Ethylene Oxide - For single use The differences between the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope models are as follow: - Working channel diameters - Insertion tube outer diameter The Veran SPiN Vision™ Video Processor has the following physical and performance characteristics: - Provides images from the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope for observation - Can connect to an external monitor - Reusable device

The SPIN Thoracic Navigation System is a stereotactic accessory for Computed Tomography (CT) and endosopic bronchoscope systems. The SPiN Thoracic Navigation System is indicated for displaying: · An interventional instrument such as a biopsy needle, an aspiration needle on a computer monitor that also displays a CT-based model of the target organ(s). · Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires in the pulmonary tract. The SPiN Thoracic Navigation System compensates for the patient's respiratory phases. The SPIN Thoracic Navigation System is in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures. The SPiN Thoracic Navigation System enables marker placement in soft lung tissue.

The SPiN Thoracic Navigation System is an accessory for a CT system that utilizes electromagnetic tracking technology to locate and navigate endoscopic tools, catheters and guidewires relative to a CT-based model of the tracheobronchial tree. Due to system use to locate structures in soft tissue. the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The SPiN Thoracic Navigation System consists of an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, software, a computer system, and a pulmonary pathway reconstruction and planning workstation. The EM tracking accessories that can be used with the SPiN Thoracic Navigation System include Veran's Always-On Tip Tracked™ Guidewire, Sheath, Aspiration Needle, Brush, Forceps or View Peripheral Catheter. The SPiN Thoracic Navigation System also enables the placement of markers in soft tissue to guide radiosurgery and thoracic surgery. The SPiN View console/View Optical Probe is provided as an additional accessory for video visualization and is a complement to the EM tracking of the View Peripheral Catheter, enhancing the navigation of the device through the vocal chords and tracheobronchial tree.

The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The ig4 System is indicated for displaying: - . An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s). - . Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires, in the pulmonary tract. The ig4™ System compensates for the patient's respiratory phases. The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.

The SPiN Drive® is an accessory for a CT system that utilizes electromagnetic tracking technology to locate and navigate endoscopic tools, catheters and guidewires relative to a CT-based model of the tracheobronchial tree. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The SPiN Drive® consists of an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, software, a computer system, and a pulmonary pathway reconstruction and planning workstation. The EM tracking accessories that can be used with the SPiN Drive® include Veran's Always-On Tip Tracked™ guidewire, steerable catheter, sheath, aspiration needle, brush or forceps.

The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle, on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4™ System is additionally indicated for overlaying Ultrasound images onto the model of the target organ(s). The ig4™ System compensates for the patient's respiratory phases. The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography, 3D fluoroscopic x-ray, or ultrasound are currently used for visualizing such procedures.

The ig4™ Image Guided System is an accessory for a CT or 3D fluoroscopic x-ray System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CTbased or 3D fluoroscopic x-ray-based model of the patient anatomy. The system software allows additional data overlay of real-time Ultrasound images onto the model of the patient anatomy. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles/Ultrasound probes or tip-tracked coaxial needle, a patient referencing system, an EM field generator and tracking system, software and a computer system.

The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The ig4 System is indicated for displaying: - . An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s). - . Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires, in the pulmonary tract. The ig4™ System compensates for the patient's respiratory phases. The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.

The ig4™ EndoBronchial is an accessory for a CT System that utilizes electromagnetic tracking technology to locate and navigate endoscopic tools, catheters and guidewires relative to a CTbased model of the tracheobronchial tree. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, software, a computer system, and a pulmonary planning workstation. The EM tracking accessory consists of a navigation guidewire and may include additional navigated endoscopic tools.

The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4™ System compensates for the patient's respiratory phases. The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography or 3D fluoroscopic x-ray are currently used for visualizing such procedures.

The ig4™ Image Guided System is an accessory for a CT or 3D fluoroscopic x-ray System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CTbased or 3D fluoroscopic x-ray-based model of the patient anatomy. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles or tip-tracked coaxial needle, a patient referencing system, an EM field generator and tracking system, software and a computer system.

The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) Systems. The ig4 System displays an interventional instrument, such as a biopsy needle, an aspiration needle, or an ablation needle, on a computer monitor that also displays a CT-based model of the target organ(s). The ig4 System compensates for the patient's respiratory phases. The ig4 System is intended to be used in clinical interventions and for anatomical structures where computed tomography is currently used for visualizing such procedures.

The ig4TM Image Guided System is an accessory for a CT System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CT-based model of the patient anatomy. Because the system is used to assist in locating structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles, a matrix of thoracic reference markers, an EM field generator and tracking system, software, and a computer system.