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100 mL/200 mL Syringe: The Disposable Syringe (Kit) (100 mL or 200 mL Syringe for the injection of contrast media orsaline for CT and MR imaging, for use on Nemoto injectors. 150 mL Syringe: The Disposable Syringe (Kit) (150 mL Syringe for the injection of contrast media or saline forangiography. for use on Nemoto injectors. J-Tube: J-Tube is to aid in transferring a media from its container (typically a vial or bottle) into the barrel of the Disposable Syringe (Kit). Extension Tubes: The Extension Tube is to provide a connection between the syringe barrel and the needle or catheter into the patient.

The "Disposable Syringe (Kit)" (Subject Device) is specifically designed for use with the Nemoto power injection systems marketed and sold in the USA using 510(k) references K133189, K071691, K173450, K092896, K091734. The Subject Device is a package provided to the end user that contains one or two plastic syringes, plastic tubing used for connecting syringe to needle or catheter (Extension Tubing) and a plastic J-shaped tube for transferring contrast media or physiological saline into the plastic syringe (J-Tube). The Subject Device, in accordance with the Indications for Use, may be used in conjunction with CT or MRI applications or in conjunction with angiographic applications. The key difference in the application as it relates to the Subject Device is the pressure required and the flow rates required for the Subject Device. The Subject Device when used for the CT and MRI applications must support a maximum pressure of 300PSI and a maximum flow rate of 10mL/second. The Subject Device when used for the angiographic applications must support a maximum pressure of 1200PSI and a maximum flow rate of 30ml/second. The maximum values related to the application are controlled by the Nemoto power injection system which are fully described in the aforementioned 510(k)s.

The PRESS DUO elite is intended to be used for injecting contrast media and common flushing solution into the vascular system in Angiographic and Computed Tomography (CT) procedures whereas the PRESS DUO elite AG is intended to be used for injecting contrast media and common flushing solution into the vascular system for Angiographic procedures only.

The main components of the PRESS DUO elite and PRESS DUO elite AG are the Console, Powerhead and Main Control Unit. The basic confiqurations of the PRESS DUO elite and PRESS DUO elite AG are a pedestal, ceiling mount or table mount configuration. With any configuration, the three main components are most often contained in the angiographic suite and normally near the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the graphical user interface with touchscreen input. The system is designed to deliver a variety of injection protocols. It can deliver single or multiple phase injections. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (like that used with laptop computers) and communicates with Main Control Unit communications interface cable. After the injection protocol has been set, the Powerhead performs the injection by driving the lead screw ram. The ram pushes the push-rod of the syringe which expels fluid from the barrel of the syringe. The only difference between the PRESS DUO elite and PRESS DUO elite AG is the availability of the CT Mode. The PRESS DUO elite provides both an Angiographic Mode and CT Mode of operation whereas the PRESS DUO elite AG has the CT Mode of operation turned off in the software and cannot be turned on by the user. All other software, hardware and mechanical aspects of the PRESS DUO elite and PRESS DUO elite AG are identical.

The contrast delivery system Dual Shot Alpha 7 is an intravascular injection system intended for the administration of ionic and non-ionic contrast media and saline used in conjunction with computed X-ray tomography (CT).

The contrast delivery system ~ Dual Shot Alpha 7 is an angiographic injector that is used in conjunction with Computed Tomography, and is intended for use by doctors, radiology technologists and other licensed medical practitioners. This device is designed to be used in conjunction with various injection methods of contrast media and saline, and utilized with multi-slice CT scanners. The Dual Shot Alpha 7 has two driving mechanisms to deliver contrast media and/or saline, each side A and B respectively are capable of utilizing either a 100mL or 200mL size syringe. Syringes are connected to the patient via an intravascular catheter. The Dual Shot Alpha 7 consists following components; Injector Powerhead, Console, and optional Hand Switch.

The contrast delivery system REMPRESS is an intravascular injection system intended for the administration of contrast media or normal saline used in conjunction with angiographic imaging procedures.

The main components of the REMPRESS are the Console, Powerhead and Main Control Unit. The configurations of the REMPRESS are a pedestal or table mount configuration. The three main components are possible in the angiographic suite and normally in close proximity to the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the operator via the graphical user interface with touchscreen input. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (similar to that integrated in a laptop computer). The Console communicates with Main Control Unit communications interface cable. After the injection protocol has been set, the Powerhead performs the injection via the contribution of the lead screw ram. The ram pushes the push-rod of the syringe which expels fluid from the barrel of the syringe.

The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and normal saline solution used in conjunction with magnetic resonance imaging (MRI).

The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and saline used in conjunction with MRI. The main components of the Sonic Shot GX are the Console, Powerhead and Main Control Unit. The Console resides in the control room or the MR suite, while the Main Unit and Powerhead reside in the scanning room alongside the MR scanning device and the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the operator via the graphical user interface with touchscreen input. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (similar to that used with laptop computers) and communicates with Main Control Unit via a fiber-optic interface. The communication link is used to communicate the user set injection parameters to the Main Control and Powerhead located in the MR suite. After the injection protocol has been set, the Powerhead performs the injection by driving one or two lead screw rams. The rams push the syringe which expels fluid from the barrel of the syringe.

The Contrast Delivery System – Dual Shot Alpha is an intravascular injection system intended for the administration of ionic and non-ionic contrast media and saline used in conjunction with computed X-ray tomography (CT).

Contrast Delivery System -- Dual Shot Alpha is an Angiographic injector that is used in conjunction with X-ray Computed tomography, and is intended for use by doctors, radiologic technologists and other licensed medical practitioners. This device is designed to correspond to the various injection methods of contrast media which were materialized with the appearance of multi-siice CT scanners. The Dual Shot Alpha has two driving parts to deliver contrast media and/or saline, one side is for 50mL, 100mL and 200mL, size syringes, and the other side for 100mL syringes capable for saline flush injection. Syringes are connected to the patient via an intravascular catheter. Dual Shot Alpha consists following components; Injector head, Console, Power Supply, and Options (Hand Switch).

The Dual Shot – Contrast Delivery System is an intravascular injection system intended for the administration of ionic and non-ionic contrast media and saline used in conjunction with computed X-ray tomography (CT).

DUAL SHOT - CONTRAST DELIVERY SYSTEM is an Angiographic injector that is used in conjunction with X-ray Computed tomography, and is intended for use by doctors, radiologic technologists and other licensed medical practitioners. This device is designed to correspond to the various injection methods of contrast media which were materialized with the appearance of multi-slice CT scanners. The DUAL SHOT has two driving parts to deliver contrast media and/or saline, one side is for 50mL, 100mL and 200mL, size syringes, and the other side for 50mL syringes capable for saline flush injection. Syringes are connected to the patient via an intravascular catheter. DUAL SHOT consists following components; Injector head, Console, Power Supply, Options (Hand Switch).