Workstation Cable

POAG Cable MC-POAG-EC6/2

Cable, AcQMap Surface ECG Output (AHA) Packaged

Power Cord, Console 2.0

AcQMap Auxiliary Interface Box, Console 2.0

AcQMap Patient Electrode Kit

AcQMap System

AcQMap System Console 2.0

The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.

The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.

The DGH 555B is a Desktop Ultrasonic Pachymeter. It is a portable, battery-powered electronic medical device that uses ultrasonic pulse technology to measure the thickness of the human cornea.

The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.

The DGH 55B is a Handheld Ultrasonic Pachymeter. It is a hand-held, battery-powered electronic medical device that uses ultrasonic pulse technology to measure the thickness of the human cornea.

The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.

The DGH 6000 is a Portable Ultrasonic A-Scan. It is an electronic device that connects to the user's PC via USB connection. It is a portable device that uses ultrasonic pulse technology to obtain axial length measurements of the human eye

The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye.

The DGH1500 is a single-element mechanical sector UBM probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software.

The DGH1500-50 is a 50 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.

The DGH1912 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software.

The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software.

The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.

The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The system consists of three main components: an interface module with integrated probe holder, one or more ultrasonic probes, and the Scanmate software application.

The pachymeter calbox is an accessory that connects to a pachymeter and creates a single precise, predetermined electronic pulse. The pachymeter measures the pulse, and the operator verifies that the measurement value is within an acceptable range.

Transducer, Ultrasonic, Diagnostic

System, Imaging, Pulsed Doppler, Ultrasonic

Transducer, Ultrasonic, Diagnostic

Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™ (TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and high fidelity 40 MHz ultrasonics for simultaneous acquisition of vessel structure and plaque composition—a single catheter, a single pullback, two sets of data. The catheter features a 40MHz wide bandwidth IVUS transducer.Indications for Use: 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Catheter Kit (TVC-C195-32) is a single use, disposable coronary catheter and accessory kit designed for use only with the TVC Imaging System™(TVC-MC9, TVC-MC9i, and properly configured TVC-MC8). The dual-modality intravascular imaging catheter combines laser-based near infrared spectroscopy (NIRS) and 50 MHz Extended Bandwidth ultrasonics for simultaneous acquisition of vessel structure and plaque composition— a single catheter, a single pullback, two sets of data. The Insight XB catheter features a 50MHz Extended Bandwidth IVUS transducer and durable hydrophilic coating for improved delivery.Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, disposable coronary catheter and accessory kit designed for use only with the Makoto Intravascular Imaging System™ (TVC-MC10 and TVC-MC10i). The dual-modality intravascular imaging catheter combines 50 MHz Extended Bandwidth IVUS transducer and laser-based near infrared spectroscopy (NIRS) for simultaneous acquisition of vessel structure and plaque composition data— a single catheter, a single pullback, two sets of data. The Dualpro™ IVUS+NIRS Imaging Catheter features a durable hydrophilic coating for improved deliverability.Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit (TVC-E195-42) is a single use, disposable coronary and peripheral imaging catheter and accessory kit designed for use only with the Makoto Intravascular Imaging System™ (TVC-MC10 and TVC-MC10i). The high definition intravascular ultrasound imaging catheter combines 50 MHz Extended Bandwidth IVUS transducer for acquisition of vessel structure. The Infraredx Clarispro™ HD-IVUS Imaging Catheter features a durable hydrophilic coating for improved deliverability.Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.b. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.

The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravascular imaging system that enables structural assessment of coronary and peripheral arteries and plaques by using integrated Extended Bandwidth IVUS imaging and chemical assessment of coronary arteries and plaques using NIRS (near infrared spectroscopy) to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50 MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) and the Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit (TVC-E195-42). Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. 2. The System is intended for ultrasound examination of coronary and peripheral intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.

The Makoto Integrated Intravascular Imaging System™ (TVC-MC10i) is a dual-modality intravascular imaging system that enables structural assessment of coronary and peripheral arteries and plaques by using integrated Extended Bandwidth™ IVUS imaging and chemical assessment of coronary arteries and plaques using NIRS (near infrared spectroscopy) to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. This model of Makoto Imaging System is designed to be installed in the catheterization laboratory and minimize usage of space. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) and the Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit (TVC-E195-42). Indications for Use:1. The Makoto Integrated Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. 2. The System is intended for ultrasound examination of coronary and peripheral intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.

Individual Sterile Barrier for TVC-MC8 or TVC-MC9 System Controller

TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32).Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. This model of TVC Imaging System is designed to be installed in the catheterization laboratory and minimize usage of space. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32). Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

A non-sterile sheath (2.0cm x 20cm) intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 100 per bag.

A non-sterile sheath 2.0cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 500 per bag.

A non-sterile sheath 2.6cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 100 per bag.

A non-sterile sheath 2.6cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 500 per bag.

A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 100 per bag.

A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 144 per bag.

A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 500 per bag.

A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, esophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. This version/model is packed 720 per bag.

A devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is a mobile assembly which support a wide variety of transducers and related application software packages.

Sterile Aquasonic 100 Ultrasound transmission gel 20 g over wrapped foil pouch

Polysonic Ultrasound Lotion w/Aloe Vera, one gallon bottle

Polysonic Ultrasound Lotion, one gallon bottle

Delphinus Sequr™ Breast Interface - GEL PAD

Ultrasound Linear Transducer

Ultrasound Convex Transducer