Other products from "INFRAREDX, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00857595006005 TVC-MC8-B1 TVC-MC8-B1 Individual Sterile Barrier for TVC-MC8 or TVC-MC9 System Controller IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation TVC Controller Sterile Barrier
2 00857595006425 TVC-MC9 TVC-MC9 TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravas 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. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation 2 TVC Imaging System™
3 00857595006418 TVC-MC8 TVC-MC8 TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC8) 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 enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging.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. OBJ,OGZ Catheter, Ultrasound, Intravascular,Catheter, Intravascular, Plaque Morphology Evaluation 2 TVC Imaging System™
4 00857595006401 TVC-MC8 TVC-MC8 TVC Imaging System™The TVC Imaging System™ (TVC-MC8) is a dual-modality intravas TVC Imaging System™The TVC Imaging System™ (TVC-MC8) 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 enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging. Non-RoHsIndications 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. OBJ,OGZ Catheter, Ultrasound, Intravascular,Catheter, Intravascular, Plaque Morphology Evaluation 2 TVC Imaging System™
5 04543660023515 GLGMF-YOK0A This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Inflation Device.The OKAY® II Y-Connector Set reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y-connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer. (YOK0A)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation. (GM-30NF)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
6 04543660023508 GLGMN-YOK0A This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer. (YOK0A)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 3 position stopcock for single angioplasty balloon inflation and deflation. (GM-30N)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
7 04543660023492 GLGMF-YOK0E This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extension tube and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube. (YOK0E)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation. (GM-30NF)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
8 04543660023485 GLGMN-YOK0E This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with This angioplasty convenience kit contains one(1) sterile pouch with OKAY-II with kit and extension tube and one(1) sterile pouch with a GM-30 Inflation Device.OKAY® II Y-Connector Set with Extension Tube reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube. (YOK0E)The GM-30 30atm-25cc inflation device features standard length, 31 cm, high pressure tubing and 3 position stopcock for single angioplasty balloon inflation and deflation. (GM-30N)Indications for Use:1. The Y-connector is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.2. The inflation device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM,DTL Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiop Syringe, Balloon Inflation, Exempt,Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 2 GM-30 Accessory Kit
9 04543660022341 YOK0B OKAY II reduces blood loss during procedures through the use of a hemostatic val OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure. DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass OKAY® II Y-Connector
10 00857595006210 TVC-C195-22 TVC-C195-22 Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC Insight Hydrophilic Catheter™ Kit The TVC Insight Hydrophilic Catheter™ Kit (TVC-C195-22) 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 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. OBJ,OGZ Catheter, Ultrasound, Intravascular,Catheter, Intravascular, Plaque Morphology Evaluation TVC Insight™
11 00857595006203 TVC-C195-20 TVC-C195-20 Insight Catheter™ Kit The TVC Insight Catheter™ Kit (TVC-C195-20) is a single us 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. IYO,OBJ,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular,Cat System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Ultrasound, Intravascular,Catheter, Intravascular, Plaque Morphology Evaluation TVC Insight™
12 04543660022662 GM-30NL GM-30NL 30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubi 30atm-25cc Inflation Device. Features extended length, 76 cm, high pressure tubing and 3 position stopcock for balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM Syringe, Balloon Inflation, Exempt 2 GM-30 Inflation Device
13 04543660022655 GM-30NF GM-30NF 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubi 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 4 position stopcock for single or dual angioplasty balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM Syringe, Balloon Inflation, Exempt 2 GM-30 Inflation Device
14 04543660022648 GM-30N GM-30N 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubi 30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 3 position stopcock for angioplasty balloon inflation and deflation.Indications for Use:1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. PTM Syringe, Balloon Inflation, Exempt 2 GM-30 Inflation Device
15 04543660022334 YOK0A OKAY II reduces blood loss during procedures through the use of a hemostatic val OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure. DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass OKAY® II Y-Connector Set
16 04543660022358 YOK0E OKAY II reduces blood loss during procedures through the use of a hemostatic val OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, introducer, and extension tube.Indications for Use:1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure. DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass OKAY® II Y-Connector Set with Extension Tube
17 00857595006227 TVC-C195-32 TVC-C195-32 Insight XB™ Catheter KitThe TVC Insight XB™ Extended Bandwidth™ NIRS-IVUS Cathet 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. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation TVC Insight XB™
18 00857595006623 TVC-MC9i TVC-MC9i TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular 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. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation 2 TVC Integrated Imaging System™
19 00857595006432 TVC-MC10 TVC-MC10 The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravasc The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated Extended Bandwidth IVUS imaging and NIRS (near infrared spectroscopy) technologies 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). 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. IYO,OGZ System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphol System, Imaging, Pulsed Echo, Ultrasonic,Catheter, Intravascular, Plaque Morphology Evaluation 2 Makoto Intravascular Imaging System™
Other products with the same Product Codes "IYO, OGZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 B995LI10050 LI-1005 Velacur is a portable ultrasonic elastography machine used to assess and monitor Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided. Velacur SONIC INCYTES MEDICAL CORP.
2 B616UVXS0 XS General Purpose Diagnostic Medical Ultrasonic Imaging System UltraVision ULTRAVISION CORPORATION
3 B616UVXR0 XR General Purpose Diagnostic Medical Ultrasonic Imaging System UltraVision ULTRAVISION CORPORATION
4 B616UVXP0 XP General Purpose Diagnostic Medical Ultrasonic Imaging System UltraVision ULTRAVISION CORPORATION
5 B510DUS70000 DUS-7000 ADVANCED ULTRASOUND ADVANCED INSTRUMENTATIONS, INC.
6 B510DUS5000A1 DUS-5000 ADVANCED ULTRASOUND ADVANCED INSTRUMENTATIONS, INC.
7 B510DUS30001 DUS-3000 ADVANCED ULTRASOUND ADVANCED INSTRUMENTATIONS, INC.
8 B377GMD61VASUS40 Vascular V4 GMD61VASUS4 USB ultrasound probe, general purpose/vascular ClearProbe GLOBALMEDIA GROUP, LLC
9 B377GMD61ENDUS40 Endocavity V4 GMD61ENDUS4 USB ultrasound probe, general purpose/endocavity. ClearProbe GLOBALMEDIA GROUP, LLC
10 B377GMD61ABDUS40 Abdominal V4 GMD61ABDUS4 USB ultrasound probe, general purpose/abdominal ClearProbe GLOBALMEDIA GROUP, LLC
11 B377GMD6180NV010 Neonatal GMD6180NV01 USB ultrasound probe, general purpose/neonatal ClearProbe GLOBALMEDIA GROUP, LLC
12 B377GMD6175VA010 Vascular GMD6175VA01 USB ultrasound probe, general purpose/vascular ClearProbe GLOBALMEDIA GROUP, LLC
13 B377GMD6175RV010 Endocavity GMD6175RV01 USB ultrasound probe, general purpose/endocavity ClearProbe GLOBALMEDIA GROUP, LLC
14 B377GMD6150AB010 Abdominal 5 MHz GMD6150AB01 USB ultrasound probe, general use/abdominal ClearProbe GLOBALMEDIA GROUP, LLC
15 B377GMD6135AB020 Abdominal 3 MHz GMD6135AB02 USB ultrasound probe, general purpose/abdominal ClearProbe GLOBALMEDIA GROUP, LLC
16 B377GMD6135AB010 Abdominal 3.5-5 MHz GMD6135AB01 USB ultrasound probe, general purpose/abdominal ClearProbe GLOBALMEDIA GROUP, LLC
17 B377GMD6112EY01 Ophthalmic GMD6112EY01 USB ultrasound probe, general purpose/ophthalmic ClearProbe GLOBALMEDIA GROUP, LLC
18 B3015017750001 Model 201 501775000 SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ul SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ultrasound imaging Systems facilitating their use as an adjunct to mammography for B-mode ultrasonic screening imaging of the breast when used with a linear array transducer consisting of the following components: Image Acquisition Station Model 201 – PN 501775-000, Image Acquisition Station Software Application V3.1.x, PN 501642, Reading Station Software Application, V3.1.x, PN 501973. SonoCine Image Acquisition Station SONOCINE, INC.
19 B201CGONE0 CGONE Clear Guide ONE CLEAR GUIDE MEDICAL, INC.
20 B201CGOHM0 CGOHM CG-OH-M The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. Clear Guide Optical Head CLEAR GUIDE MEDICAL, INC.
21 B201CGOH0 CGOH CG-OH The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. Clear Guide Optical Head CLEAR GUIDE MEDICAL, INC.
22 B201CGCORE170 CGCORE17 CG-CORE17 The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen. Clear Guide CORE CLEAR GUIDE MEDICAL, INC.
23 B118314170 Classic Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series. Sonocubic 3D Ultrasound Software MEDGE PLATFORMS INC
24 B118314160 Classic Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series. Sonocubic 3D Ultrasound Software MEDGE PLATFORMS INC
25 B017ED102 EyeSeal Disposable ED1 ArcScan Insight 100 ARCSCAN, INC.
26 B017AS100 AS100 AS100-120 ArcScan Insight 100 ARCSCAN, INC.
27 B015000010 00001 Accuro RIVANNA MEDICAL, LLC
28 90814277020127 21-05012-01 Sterile Transducer Cover - individual cover in envelope Sonic Window Sterile Transducer Cover ANALOGIC CORPORATION
29 90814277020028 10-73868-02 Replacement unit for Sonic Window Handheld Ultrasound System Sonic Window Handheld Ultrasound Unit ANALOGIC CORPORATION
30 90814277020011 10-73869-01 Docking Station for Sonic Window Handheld Ultrasound System Sonic Window Docking Station ANALOGIC CORPORATION
31 90814277020004 10-73690-02 The Sonic Window is intended for the visualization of vessels and vascular acces The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only. Sonic Window Handheld Ultrasound System ANALOGIC CORPORATION
32 60889971738837 Touch Prime Ultrasound System 1738830 XE Edition Touch Prime Ultrasound System CARESTREAM HEALTH, INC.
33 60889971738820 Touch Prime Ultrasound System 1738822 Touch Prime Ultrasound System Touch Prime Ultrasound System CARESTREAM HEALTH, INC.
34 58051887042642 THD HRStation 800299 THD HRStation is an integrated proctological station mainly dedicated to the dia THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions.Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound. THD Procto Software System THD SPA
35 40841716102552 017986 HDi System Overpack p/n 800994-005Contents: System Console, Linear Translation S HDi System Overpack p/n 800994-005Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply ACIST HDi® HD IVUS System ACIST MEDICAL SYSTEMS, INC.
36 30856724004357 06-050-030 Clear Image Singles Lite NEXT MEDICAL PRODUCTS, LLC
37 30856724004340 17903 Ultrasound Gel, High Viscosity ClearWave NEXT MEDICAL PRODUCTS, LLC
38 30856724004333 17000 Ultrasound Gel, Medium Viscosity ClearWave NEXT MEDICAL PRODUCTS, LLC
39 30856724004326 02-050-030 Clear Image Singles NEXT MEDICAL PRODUCTS, LLC
40 30856724004203 05-812 Clear Image Ultrasound Gel, Medium Viscosity, 8 oz. Clear Image NEXT MEDICAL PRODUCTS, LLC
41 30856724004197 02-812 Clear Image Ultrasound Gel, High Viscosity, 8 oz. bottle Clear Image NEXT MEDICAL PRODUCTS, LLC
42 30856724004166 04-048-020 Clear Image Sterile Ultrasound Gel, 20ml Clear Image Singles Sterile NEXT MEDICAL PRODUCTS, LLC
43 30856724004159 11-405 LithoClear NEXT MEDICAL PRODUCTS, LLC
44 30856724004142 11-601 LithoClear NEXT MEDICAL PRODUCTS, LLC
45 30856724004135 06-400-030 Clear Image Singles Lite NEXT MEDICAL PRODUCTS, LLC
46 30856724004128 06-400B-030 Clear Image Singles Lite NEXT MEDICAL PRODUCTS, LLC
47 30856724004104 02-400-015 Clear Image Singles, High Viscosity, 15ml Clear Image Singles NEXT MEDICAL PRODUCTS, LLC
48 30856724004098 02-400B-015 Clear Image Singles, High Viscosity, 15ml Clear Image Singles NEXT MEDICAL PRODUCTS, LLC
49 30856724004074 02-400-030 Clear Image Singles, High Viscosity Clear Image Singles NEXT MEDICAL PRODUCTS, LLC
50 30856724004067 02-400B-030 Clear Image Singles, High Viscosity Clear Image Singles NEXT MEDICAL PRODUCTS, LLC