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The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is indicated for the transfer of Gadavist® (gadobutrol) injection contrast media as supplied in an approved Imaging Bulk package presentation (30 mL or 65mL) to empty, sterile hand syringes and/or empty, sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for MR procedures. The Transfer Spike is to be discarded after one of the following conditions has occurred first: the contrast media container has been depleted, the Transfer Spike has been disconnected from the contrast vial, or after 24 hours has elapsed since the container was penetrated.

The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is a pre-administration filling device that is designed to transfer fluid from an imaging bulk package into multiple sterile syringes via a powered injector system prior to an MR procedure. There is no direct patient contact with the use of this device. It is intended to spike one bulk package of Gadavist® (gadobutrol) injection contrast media only. Each imaging bulk transfer set consists of a spike and a swabbable valve. The transfer spike is provided sterile, individually packaged, and is not intended to be resterilized.

The MEDRAD® Mark 7 Arterion Injection System is indicated to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies. Imaging System Interface (ISI) The ISI option is indicated for the specific purpose of allowing a MEDRAD® Mark 7 Arterion Injection System to interface with an angiography imaging system.

The MEDRAD Mark 7 Arterion Iniector is a software-controlled medical device used to inject contrast agents from a 150 ml disposable syringe. Commonly referred to as an automated injection system, it is designed to allow a user to fill a disposable syringe and perform an injection with a user programmed volume and flow rate.

MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation: The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. MEDRAD® Stellant FLEX Syringe Kits: The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. MEDRAD® Stellant CT Injection System with Certegra Workstation: The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. MEDRAD® Stellant Syringe Kits: The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors. MEDRAD® Stellant Connector Tubing: The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors. P3T Cardiac: P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta. P3T PA: P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta. P3T Abdomen: P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys). ISI: The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner. Connect.CT: The Connect. CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.

The MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes to perform an injection with a user-programmed volume, flow rate and/or duration. The MEDRAD Stellant CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes to perform an injection with a user-programmed volume, flow rate and/or duration. The Stellant P3T software accessories compute individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration for individualized dosing, and for increasing the consistency of individualized injection protocols among clinicians. The ISI module options allow an injector to interface with a CT scanner. The Connect.CT application allows an injector to interface with a CT scanner.

The MEDRAD® MRXperion MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic resonance imaging (MR) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.

The MEDRAD MRXperion MR Injection System is a software-controlled medical device used for the administration of intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes and then to perform an injection with a userprogrammed volume and flow rate.

MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation: The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. MEDRAD® Stellant FLEX Syringe Kits: The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. MEDRAD® Stellant CT Injection System with Certegra Workstation: The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. MEDRAD® Stellant Syringe Kits: The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors. MEDRAD® Stellant Connector Tubing: The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors. P3T Cardiac: P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta. P3T PA: P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta. P3T Abdomen: P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys). ISI: The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner. Connect.CT: The Connect. CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation: The MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes to perform an injection with a user-programmed volume, flow rate and/or duration. MEDRAD Stellant CT Injection System with Certegra Workstation: The MEDRAD Stellant CT Injection System with Certegra Workstation is a software-controlled medical device used for the administration of intravenous CT contrast media and saline into the human vascular system for diagnostic studies in Computed Tomography (CT) procedures. Commonly referred to as an automated injection svstem, it is designed to allow a user to fill disposable svringes to perform an injection with a user-programmed volume, flow rate and/or duration. Personalized Patient Protocol Technology (P3T): The Stellant P3T software accessories compute individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration for individualized dosing, and for increasing the consistency of individualized injection protocols among clinicians. Imaging System Interface (ISI): The ISI module options allow an injector to interface with a CT scanner. Connect.CT: The Connect.CT application allows an injector to interface with a CT scanner.

The MEDRAD® MRXperion MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.

The MEDRAD MRXperion MR Injection System is a software-controlled medical device used for the administration of intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes and then to perform an injection with a user-programmed volume and flow rate. The MEDRAD MRXperion MR Injector consists of two basic modules: a Scan Room Unit (SRU) and a Control Room Unit (CRU). The SRU is comprised of an integral injector head, base assembly, pedestal, and a power supply. - The injector head of the SRU physically performs the injection. . - . The base assembly functions as the interface between the CRU, the injector head, and the SRU power supply. - . The injector head and base are located on a pedestal is designed with locking casters to allow the SRU to be moved when not connected to a patient. - . To power the base assembly, power is received from the AC mains and is converted to DC voltage by the SRU power supply. The CRU consists of an All-in-One Computer (AlOC), pod, their dedicated power supplies, mechanical stand, and an optional hand switch. - The AIOC provides a platform for the graphical user interface for the injector as well as ● the optional informatics applications. From the AIOC, an operator can use the touchscreen display to manage protocols, arm and disarm the injector, review injection realtime progress/feedback and history, access eGFR and patient Weight-Based Dosing calculators, and set system configuration options. The operator can also use the features of the optional informatics device from the AIOC. - The pod provides injection start and stop functionality and contains the safety controls . for the CRU. - . To power the AIOC and pod, each component receives AC mains power from its own dedicated off-the-shelf power supply. - The AIOC and pod are mounted on a desk top mechanical stand. - . An optional hand switch gives the operator an additional means to start, hold, and stop an injection from the Control Room. The hand switch contains a light that identifies the state of the injector.