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The ClotTriever Thrombectomy System is indicated for : - · The non-surgical removal of thrombi and emboli from blood vessels. - · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath comprises a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a Large Bore 60 cc syringe. The ClotTriever Catheter comprises reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.

The TNI softFlow 50 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. The TNI softFlow 50 is for adult patients in hospitals and long-term care facilities. The flow may be from 10-50 L/min. The TNI softFlow 50 is not indicated for life support measures.

The softFlow 50 system is a high flow heated humidifier for respiratory gases with integrated flow source and a heated breathing tube to deliver conditioned respiratory gases to a patient. The air or air/oxygen mixture is both humidified and heated. A nasal cannula serves as applicator, similar to the nasal cannula used during oxygen ventilation therapy. The nasal applicator is no compatible with a tracheostoma. The nasal applicator is sold separately as a disposable accessory that is replaced after 14 days (336 hours). The softFlow 50 is for the treatment of spontaneously breathing adult patients in hospitals and long-term care facilities who would benefit from receiving high flow warmed and humidified respiratory gases. The flow may be from 10-50 L/min depending on the patient interface. The humidifier clinic complete is sold separately so that the patient can replace the airlift, the humidification chamber, and the bacterial filter. The humidifier clinic is sold separately as a disposable accessory that is replaced weekly.

The SunilQ Digital Radiography system is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

The SuniIQ Digital Radiography System reduces x-ray exposure by producing real time digital intra-oral images. The System accomplishes this by replacing X-ray film with a reusable electronic sensor that captures the X-ray photons and converts them to an electronic signal which, in turn, is captured in a computer for viewing, manipulating, storing, and output.

The Herniatome Percutaneous Discectomy Device is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

The Herniatome Percutaneous Discectomy Kit is comprised of an Introducer needle and a Herniatome Percutaneous Discectomy Device. The Herniatome Percutaneous Discectomy Device is a single-use disposable discectomy device that is designed to remove intervertebral disc nucleus pulpous material under CT and fluoroscopic guidance. Radiopaque marker bands are located on the Introducer needle and the Herniatome Percutaneous Discectomy Device. The Herniatome Percutaneous Discectomy Device contains a battery source DC motor that causes the internal double pitch mechanism to act as a screw conveyor to retrieve and remove the excised debris through the outer cannula and into the transparent collection container. The Herniatome Percutaneous Discectomy Device is provided in two base models, a curved or straight distal end cannula with a lateral window and each model is provided with two different gage cannulas and two different cannula lengths for utilization in the specific region of the spine.

To allow airflow over the vocal cords for speaking function. To be used with a standard 15 mm connection on tracheostomy tubes.

The Shikani speaking valve consists of a plastic housing with a captured ball that acts as a check valve. Once attached to the tracheostomy tube connector the speaking valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal cords which facilitates speech or phonation.

The Suni3D is a computed tomography x-ray system, which is a diagnostic x-ray system intended to produce panoramic, cephalometric, and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structures by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

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The ONI MSK Extreme™ MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.

The MSK Extreme™ MR Scanner utilizes a superconducting magnet to acquire 2D single-slice and multi-slice and 3D volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system is used as a stationary system.

The NICaS 2004 Slim is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance), in males and females needing cardiac output assessment, including patients with cardiac disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.

The NICaS (non-invasive cardiac system) is a CD-ROM shaped device which replaces the actual CD-Rom of a laptop computer. It is used for noninvasive cardiac diagnostic purposes. The NICaS (non-invasive cardiac system) SLIM 2004 is an impedance device which is unique in its use of a laptop computer as part of a technology for non-invasively measuring the cardiac output and its derivatives. The NICaS is also unique in that it is the only method of impedance cardiography (ICG) which utilizes only two pairs of impedance electrodes, placed on two limbs, preferably one pair on the wrist, and the other on the contra-lateral ankle. This type of electrical surveillance is called regional ICG, or RIC. The NICaS is a tetrapolar apparatus which operates by an alternating current of 1.4 mA and 32 kHZ. The principle of this technology is based on the fact that the electrical conductance of the blood is higher than that of the surrounding tissue structures. Consequently, with each arterial systolic expansion (pulsation), an increase in the electrical conductance (or reduction in the electrical resistance) of the body is measured. This systolic resistance (impedance) change is termed OR, and the baseline body resistance is R (0). The analog resistance signals are received by the device, where they are amplified and filtered. These signals are then transmitted to a microprocessor. where they are digitized and analyzed via mathematical algorithms.

The SuniRay II Digital Radiography System is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

The Suni SuniRay II Digital Radiography System ("System") will produce real time digital intra-oral images with a reduction in X-ray dosages as compared to film. The System accomplishes this by replacing X-ray film with an electronic sensor that captures the X-ray photons and converts the photons to an electronic signal which in turn is captured in a computer for viewing, manipulating, storing, and outputting (printing or Email). The System consists of two sensor versions (designated as #1 & #2 sizes; equivalent to dental film sizes), an attached USB electronics box that controls the sensor and interfaces to the computer USB port. The System also includes software drivers that control the USB electronics box, and a Graphical User Interface (GUI) that allows the user access to the data and control functions of the System. The GUI used with the device was designed by Apteryx, Inc. who holds 510(k) K983111 for their product. Apteryx is responsible for both product validation and GMP compliance. The SuniRay II System software utilizes the Windows XP environment. The System sensors are in two formats. The #2 size is a larger sensor typical of the European format and the # 1 size is an intermediate size. The sensors consist of a CMOS type integrated circuit, and a high resolution scintillator screen that converts the photons from the X-rays into visible light, which is then acquired by the CMOS imaging integrated circuit. The sensors are encapsulated with a three-foot cable that is connected to the USB electronics box. The USB electronics box plugs into a computer USB port via a supplied USB cable. The USB electronics box contains the support and control circuitry for the sensor and allows for data communications with the computer. The USB electronics box contains all necessary circuits for sensor data acquisition as well as memory for firmware control of the CMOS X-ray sensor and USB. The USB electronics box communicates with the computer under control of a specific device driver that is active with the GUI. The System software functions on three levels: (1) The computer operating system (Microsoft Windows) controls the computer, user interface, and file structure; (2) Primary control of the sensor and bus functions is achieved by proprietary software and is either embedded firmware or in non user accessible drivers; and (3) A Graphical User Interface (GUI) allows the user to control the x-ray function, control of the sensor data acquisition, and image viewing, manipulation and output. Examples of the GUI include image capture, enhanced viewing features (zoom, pan, colorize, contrast/brightness, comparative analysis, etc) image organization, and storage.

For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.

Axial rotation x-ray source (PC-1000). The PC-1000 panoramic X-ray machine portion of the Sunipan Imaging System generates the required ionizing radiation (x-rays) This unit is identical to the PC-1000 model supplied directly by Panoramic Corporation for use with standard x-ray film. The Sunipan Imaging System combines this base x-ray unit with an available aftermarket digital imaging sensor, creating a filmless digital imaging system. Digital Image Sensor (Scan300fp/Retropan) is a high speed x-ray camera tailored for dental panographic applications. Originally designed and cleared for retro-conversion of existing standard panographic x-ray units. The sensor system utilizes direct conversion technology which offers a number of benefits over CCD technology. The images obtained may be reviewed and adjusted after exposure to focus on different layers or areas of clinical it rest.