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Injector: Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner EDA: The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector.

The EmpowerCT and EmpowerCTA Injector Systems have been modified for a software change only specific to the Empower Remote Control. They have been modified to add an optional calculator for glomerular filtration rate (GFR). This optional calculator is used as an additional screening tool for the use of a CT contrast injection in conjunction with a CT scan. This calculator does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system.

EmpowerMR: Vascular administration of contrast media and flushing media in conjunction with magnetic resonance (MR) imaging.

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The EmpowerCTA Injector system is intended for the vascular administration of contrast and flushing media and the EmpowerCT Injector system is intended for vascular administration of contrast. Both injector systems are used in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner.

The EmpowerCT and EmpowerCTA Injector Systems are currently marketed as injection systems that use one or two consumable syringe(s) to displace contrast media and flushing media (EmpowerCTA only) to the patient. A motor driven linear actuator mechanism controls displacement of the syringe piston. The currently marketed injector systems consist of four components. These include the Injector, Remote Control, EDA and Power Supply. Consistent with currently marketed devices, the proposed device will allow the user to administer the contrast media to the patient by specifying the following variables at the remote control. Volume- Volume is selectable from 1 ml to 200 ml in 1 ml increments. Flow Rate- Flow rates are selectable from 0.1 to 10 ml/sec in increments of 0.1ml/sec. Pressure- Maximum syringe pressure is selectable from 40-300 psi in increments of 1 psi

The E-Z-EM ENDOSCOPIC CO2 REGULATOR is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The ENDOSCOPIC CO2 REGULATOR allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the Light Source of the Endoscopic equipment.

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The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.

The Empower Transfer Set is a disposable set used to transfer contrast media or saline from a container that can be spiked to a CT power Injector syringe.

CT Injector: Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body. EDA: The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector.

The EmpowerCTA Injector System is an injection system that uses one or two consumable syringe(s) to displace contrast media and flushing media to the patient. A motor driven linear actuator controls displacement of the syringe piston. This method of contrast injection is consistent with predicate devices from E-Z-EM for over 12 years. This new version of the EmpowerCT Injector family addresses the addition of a second syringe for the device for purposes of displacing flushing media.

The E-Z-EM PROTOCO2L COLON Insufflator administers and regulates carbon dioxide (CO2) as a distention media to the colon during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.

The EZEM PROTOCO>L with performance improvements, as with the predicate device is an insufflation system that is used in conjunction with a consumable and is intended to displace and regulate carbon dioxide (CO2) as a distention media to a patient's colon for purposes of CT Colonography and conventional colonoscopy. As with the predicate, the PROTOCO2L system with performance improvements consists of 3 components. These are the insufflator, consumable and accessory cart.

The E-Z-EM PROTOCO₂L COLON Insufflator administers and regulates carbon dioxide (CC)) as a convention The E-Z-EM PROTOCOL COLON Insultiator administers and regaller one of the research and conventional Colonoscopy.

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The device is indicated for the administration of ionic and nonionic compounds in conjunction with computed tomography scanning of the body. The extravasation detecting electrode patch element of the device is indicated for contact with intact skin and single use only.

PercuPump II with EDA (Extravasation Detection Accessory)