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The Liebel-Flarsheim™ IBP Transfer Set is indicated for the transfer of Optiray® (loversol) Imaging Bulk Package contrast media to empty, single-use only, sterile syringes on syringe based contrast injection systems indicated for the controlled, automatic intra-vascular administration of radiopaque contrast agents for their indicated procedures. The IBP Transfer Set is to be discarded after the contrast media container has been emptied or after 12 hours have elapsed since the container has been penetrated, whichever occurs first. Contra-indications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts.

The Liebel-Flarsheim™ IBP Transfer Set is a sterile tubing set connection between Optiray® (Ioversol) contrast media imaging bulk packages (hereinafter Optiray IBPs) and empty sterile singleuse syringes on syringe-based automatic contrast injection systems. The Liebel- Flarsheim™ IBP Transfer Set consists of a small bore (1/8" ID) clear polyvinyl chloride (PVC) tube with standard medical component end terminations. Bonded to the proximal end of the PVC tube is a vented IV spike that is used to pierce a rubber stopper belonging to an imaging bulk contrast media container. Distally, a self-sealing Luer type connector (Smiths Medical Nu- Site®) is bonded to the opposite end of the PVC tube. The Liebel-Flarsheim™ IBP Transfer Set, shown in the image below, has an overall length of 19-inches, a protective cap on the IV Spike, and both untethered and tethered protective caps on the Luer end to protect the Nu-Site® Luer Activated fitting between syringe fills. The transfer sets are individually packaged in blister packs with a perimeter heat sealed Tyvek lid. Sealed blister packs are packaged in an outer box containing 50 units (50 units/box) which are terminally sterilized with ethylene oxide. The Liebel-Flarsheim™ IBP Transfer Set is intended for the transfer of fluids from bulk containers to empty sterile syringes on syringe-based contrast injection systems.

The OptiOne Single-Head Contrast Delivery System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images with computed tomography (i.e. "CT") equipment.

The OptiOne Single-Head Contrast Delivery System (OptiOne) is intended to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used in conjunction with computed tomography equipment. Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume, pressure and timing. The OptiOne consists of the following key components: a Powerhead, a Console, and a Power Supply. The Power Supply delivers power to the Powerhead and Console. The Console provides remote control and programmability of the injection through a touch screen display system. The Powerhead contains the components to perform the actual injection such as motor control circuits, ball screw and syringe push ram.

The Liebel-Flarsheim Direct Digital Imaging System is a solid state detector X-ray system that facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/surgery. The system may be used for urological, gastroenterological, and gynecological treatment, planning and diagnostic procedures. It is intended to replace fluoroscopic images formerly obtained through image intensifier technology. Not intended for mammography applications.

The Liebel-Flarsheim Direct Digital Imaging System is a radiographic and fluoroscopy examination' table with the X-ray tube over the table and the detector underneath the patient table. The table top can be moved longitudinally and laterally as well as vertically. The imaging system and table top can be rotated in the Trendelenburg and reverse-Trendelenburg positions. The system is a modified version of the Hydra Vision Urological X-Ray System (marketed as Hydra Vision Plus DR System). The modification features a multipurpose (radiography and fluoroscopy) solid state digital detector in place of the Image Intensifier and CCD camera for image acquisition. The table design remains unchanged.

The Syringe with Handi-Fil is part of the contrast delivery system which is designed to mject radiopaque contrast media and/or salıne into the vascular system for Angiographic or CT procedures as prescribed by qualified healthcare professionals

The proposed device is a disposable, single-use syringe, used to deliver radiographic contrast media and/or salme into a patient's vascular system for the purpose of obtaming enhanced diagnostic images The Syringe with Handi-Fil is plastic and consists of the same components as the predicate device The configuration is equivalent to other syringes already marketed by Mallinckrodt The synnge is provided to the customer packaged and sterilized. This submission covers the following devices: 150 ml syringe with Handı-Fil, 200 ml syringe with Handı-Fil.

The Optistar Elite Injection System is a contrast delivery system and is designed to inject MR contrast media and flushing solutions into a patient's vascular system to obtain diagnostic images when used with Magnetic Resonance Imaging equipment.

The Optistar Elite is a delivery system designed to inject image enhancing MR contrast media and flushing solutions into the vascular system for the purpose of obtaining enhanced diagnostic images. The Optistar Elite consists of 4 main components and syringes, just like the predicate device: Power Head, Console, Power Control, and Power Supply. Syringes accommodated include Mallinokrodt Optimark pre-filled syringes (10 ml, 15 ml, 20 ml, 30 ml), Mallinckrodt pre-filled saline syringes (50ml and 125 ml), and empty disposable 60 ml Mallinckrodt syringes.

The OptiVantage DH Injector System with Enhanced Communication is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The OptiVantage DH Injector System with Enhanced Communication delivers radiographic contrast media and/or saline at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiVantage DH Injector System with Enhanced Communication consists of 4 main components, just like the predicate device: - Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knobs. The OptiVantage uses a drive system that is similar to existing Mallinckrodt injectors in the marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drives a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe. - Power Supply- The power supply converts the line voltage to the working voltage for the power head and console (approximately 24-vdc). - Console Communicates with the Power Head to program and initiate injection protocols, displays the injection status, and displays a timer. - Syringes The OptiVantage DH Injector System with Enhanced Communication accommodates the Syringes - The Oper rainage styles as well as a 200 ml front loading empty syringe. These Minimonrol. I 22 million place on the market and are currently used with the predicate device.

The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The OptiVantage DH Injection System delivers radiographic contrast media and/or saline at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiVantage is made up of the following major components: - Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knpbs. The OptiVantage uses a drive system that is similar to existing Mallinetcrodt injectors. 11he marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drines a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe. - Power Supply- The power supply converts the line voltage to the working voltage for the power . head and console (approximately 24-vdc). - Console Communicates with the Power Head to program and initiate injection protocols, . displays the injection status, and displays a timer. - Syringes The OptiVantage Injection System accommodates the Mallinckrodt 125-ml pre-filled . syringe styles and pre-filled saline syringes as well as a 200 ml front loading empty syringe. These syringes are commonplace on the market.

The CT9000ADV is designed to inject a radiopaque contrast media into a patient's vascular system, which enhances diagnostic images obtained with computed tomography (i.e. "CT"). Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume and timing.

The CT9000ADV / OptiBolus Injection System delivers radiographic contrast media at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiBolus feature is used to enable an exponential decaying flow rate injection that will optimize the contrast usage and provide an extended period of uniform enhancement. The OptiBolus feature can be turned on or off by the user for any given injection protocol. The major components of the system are: 1. Power Head- The CT 9000ADV / OptiBolus Powerhead is contained in a sturdy metal case. The Powerhead contains the operator interfaces for viewing injection information, controlling the fill and expel operation, starting and stopping an injections for enabled and injecting states and the interface for connection of the various syringes. The Powerhead communicates its gathered information to the Power Pack. 2. Power Pack- Contains the power supply and main microprocessor. The power supply converts the line voltage to the working voltage for the powerhead and console (approximately 24-vdc). The main processor provides a centralized control system for all system functions. The Powerhead and Console each contain a remote microprocessor that is used to control their localized functions. 3. Console- Communicates with the Power Pack to program and initiate injection protocols, displays the injection status, and displays an iniection timer. The Console provides the means for the operator to enable, disable and view an OptiBolus injection. The Console display provides a simulated display that represents the OptiBolus injection as it progresses. 4. Syringes- The CT9000ADV / OptiBolus Injection System accommodates the Mallinckrodt 125-ml pre-filled syringe styles. It is also accommodates the Liebel-Flarsheim 200-ml syringe. These syringes are commonplace on the market.

The ELPH Injection System is a contrast delivery system which is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The ELPH Injection System will deliver radiographic contrast media at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The ELPH is made up of the following major components: Power Head, Power Pack, Remote Console (Optional), Syringes.

The Optistar MR Injector System is intended for injecting MR contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans.

The Optistar MR is a contrast delivery system that is designed to inject image enhancing contrast media into the vascular system of a human during an MRI (Magnetic Resonance Imaging) procedure. The main components of the Optistar MR system are the console, power pack, and powerhead. The console resides in the control room of the MR suite, while the power pack and powerhead remain in the scanning room with the patient. The parameters of the injection, such as volume and flow rate are programmed by the operator using a touch screen on the console. The console is powered by AC line voltage at 110 Volts at 60 Hz. The console communicates with the 24 VDC powerpack which in turn supplies power and the injection parameters to the powerhead. The powerhead performs the injections by driving one or two lead screw rams. The rams push the plunger of a syringe, which expels fluid from the barrel of the syringe.