Other products from "ACUTUS MEDICAL, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00850027837192 800698 800698 SmartAblate™ Adapter Cable AcQMap to Catheter DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
2 00857042007999 900000 900000 AcQMap System DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
3 00857042007920 900100 900100 AcQMap System Console 2.0 DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
4 00857042007562 800605 800605 AcQMap Patient Electrode Kit DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
5 00857042007425 800604 800604 AcQMap Auxiliary Interface Box, Console 2.0 DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
6 00857042007418 800530 800530 AcQMap Catheter Interface Cable MTD,ITX Catheter, Intracardiac Mapping, High-Density Array,Transducer, Ultrasonic, Diagnostic 2 AcQMap
7 00857042007401 900009 900009 AcQMap 3D Imaging & Mapping Catheter MTD,ITX Catheter, Intracardiac Mapping, High-Density Array,Transducer, Ultrasonic, Diagnostic 2 AcQMap
8 00857042007388 800531 800531 Cable, AcQMap Surface ECG Output (AHA) Packaged DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
9 00857042007364 800405 800405 POAG Cable MC-POAG-EC6/2 DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
10 00857042007357 800255 800255 Workstation Cable DQK,ITX,IYO Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Im Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic 2 AcQMap
11 00857042007333 800601 800601 Power Cord, Console 2.0 DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
12 00857042007326 800505 800505 AcQMap Ablation Reference Cable DQK Computer, Diagnostic, Programmable 2 AcQMap
13 00857042007319 800508 800508 AcQMap Ablation Electrogram Cable DQK Computer, Diagnostic, Programmable 2 AcQMap
14 00857042007302 800422 800422 AcQMap Auxiliary Interface Box DQK Computer, Diagnostic, Programmable 2 AcQMap
15 00857042007296 800500 800500 AcQMap Console DQK Computer, Diagnostic, Programmable 2 AcQMap
16 00857042007289 800520 800520 AcQMap Workstation DQK Computer, Diagnostic, Programmable 2 AcQMap
17 00857042007272 800523 800523 AcQMap 2mm Pin Jumper St DQK Computer, Diagnostic, Programmable 2 AcQMap
18 00857042007265 800522 800522 AcQMap ECG w/Snaps Cable DQK Computer, Diagnostic, Programmable 2 AcQMap
19 00857042007258 800524 800524 AcQMap ECG POST Cable DQK Computer, Diagnostic, Programmable 2 AcQMap
20 00857042007241 800421 800421 AcQMap ECG Input Cable DQK Computer, Diagnostic, Programmable 2 AcQMap
21 00857042007234 800424 800424 AcQMap ECG Output Cable DQK Computer, Diagnostic, Programmable 2 AcQMap
22 00857042007135 800431 800431 Ampere® Adapter Cable AcQMap®→ Ampere DQK Computer, Diagnostic, Programmable 2 AcQMap
23 00857042007128 800407 800407 AcQMap® Surface ECG Cable DQK Computer, Diagnostic, Programmable 2 AcQMap
24 00857042007111 800109 800109 AcQMap® Auxiliary Catheter Cable DQK Computer, Diagnostic, Programmable 2 AcQMap
25 00857042007104 800112 800112 AcQMap® Ablation Interface Unit Cable DQK Computer, Diagnostic, Programmable 2 AcQMap
26 00857042007098 800113 800113 AcQMap® Patient Interface Unit Cable DQK Computer, Diagnostic, Programmable 2 AcQMap
27 00857042007081 800229 800229 AcQMap® Patient Interface Unit DQK Computer, Diagnostic, Programmable 2 AcQMap
28 00857042007074 800430 800430 Ampere® Adapter CableAcQMap® → Ablation Catheter DQK Computer, Diagnostic, Programmable 2 AcQMap
29 00857042007067 800244-001 800244-001 AcQMap® Ablation Interface Unit DQK Computer, Diagnostic, Programmable 2 AcQMap
30 00857042007050 800254 800254 AcQMap® Workstation DQK Computer, Diagnostic, Programmable 2 AcQMap
31 00857042007043 800258 800258 AcQMap® Console DQK Computer, Diagnostic, Programmable 2 AcQMap
32 00857042007036 800365-002 800365-002 AcQMap® Patient Electrode Kit DRX Electrode, Electrocardiograph AcQMap
33 00857042007029 900003 900003 AcQMap® 3D Imaging & Mapping Catheter MTD Catheter,Intracardiac Mapping,High-Density Array 2 AcQMap
34 00857042007005 800426 800426 North America Power Cord DQK Computer, Diagnostic, Programmable 2 AcQMap
35 00850027837482 800748 800748 Maestro Adapter Cable, AcQMap to Catheter DQK,ITX,IYO Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Im Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic 2 AcQMap
36 00850027837475 800745 800745 Maestro Adapter Cable, AcQMap to Generator DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
37 00850027837468 800742 800742 Adapter Cable-Long, Ablation Adapter to AcQMap DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
38 00850027837451 800739 800739 Adapter Cable-Short, Ablation Adapter to AcQMap DQK,ITX,IYO Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Im Computer, Diagnostic, Programmable,Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic 2 AcQMap
39 00850027837444 800710 800710 Carto Force Adapter Cable Shipping Assembly DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
40 00850027837239 800696 800696 AcQMap to SmartAblate Generator Adapter DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
41 00850027837222 800695 800695 AcQMap to SmartAblate Generator Adapter DQK,IYO,ITX Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Tran Computer, Diagnostic, Programmable,System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 AcQMap
42 00857042007517 222852 222852 AcQGuide Flex RF 65 cm Med Curl DYB Introducer, Catheter 2 AcQGuide Flex
43 00857042007500 012852 012852 AcQGuide Mini-S, 65cm - L2 with AcQCross QX DYB Introducer, Catheter 2 AcQGuide Mini-S
44 00850027837161 900305 900305 AcQCross Qx - MAX 70cm DYB Introducer, Catheter 2 AcQCross Qx
45 00850027837147 900304 900304 AcQCross Qx - FC 65cm DYB Introducer, Catheter 2 AcQCross Qx
46 00850027837123 900303 900303 AcQCross Qx - VZ 71cm DYB Introducer, Catheter 2 AcQCross Qx
47 00850027837659 900218 900218 StabilICE HYA,DWS Forceps, Wire Holding,Instruments, Surgical, Cardiovascular 1 StabilICE
48 00850027837642 900221 900221 StabilICE HYA,DWS Forceps, Wire Holding,Instruments, Surgical, Cardiovascular 1 StabilICE
49 00850027837611 900309 DYB,DRE Introducer, Catheter,Dilator, Vessel, For Percutaneous Catheterization 2 AcQCross Qx Integrated Transseptal Dilator/Needle
50 00850027837598 900308 DYB,DRE Introducer, Catheter,Dilator, Vessel, For Percutaneous Catheterization 2 AcQCross Qx Integrated Transseptal Dilator/Needle
Other products with the same Product Codes "DQK, IYO, ITX"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00860226002536 VS-V2 VIS0101 Visura TEECAD Carrier Control Unit Visura TEECAD Carrier Control Unit VISURA TECHNOLOGIES, INC.
2 00860226002529 CR-P2 VIS0100 Visura TEECAD Carrier Visura TEECAD Carrier VISURA TECHNOLOGIES, INC.
3 00860226002512 VS-V1 TEECAD Viewing System TEECAD VISURA TECHNOLOGIES, INC.
4 00860226002505 CR-P1 TEECAD Carrier - PX72T TEECAD VISURA TECHNOLOGIES, INC.
5 00860008461223 uREzpocus M Ultrasonic pulsed doppler imaging system - MicroConvex array uREzpocus NORLAND AT SWISSRAY
6 00860008461223 uREzpocus M Ultrasonic pulsed doppler imaging system - MicroConvex array uREzpocus NORLAND AT SWISSRAY
7 00860008461216 uREzpocus H Ultrasonic pulsed doppler imaging system - uREzpocus H uREzpocus NORLAND AT SWISSRAY
8 00860008461216 uREzpocus H Ultrasonic pulsed doppler imaging system - uREzpocus H uREzpocus NORLAND AT SWISSRAY
9 00860008461209 uREzpocus C-EMS Ultrasonic pulsed doppler imaging system - Convex HD array uREzpocus NORLAND AT SWISSRAY
10 00860008461209 uREzpocus C-EMS Ultrasonic pulsed doppler imaging system - Convex HD array uREzpocus NORLAND AT SWISSRAY
11 00860007954177 VMCU1 vMap Control Unit VEKTOR MEDICAL, INC.
12 00860007954108 VMDISP1 vMap Disposables VEKTOR MEDICAL, INC.
13 00860007188343 S12BP4 Transducer S12BP4 – 11 mm Neurosurgery Probe Transducer S12BP4 FUJIFILM HEALTHCARE AMERICAS CORPORATION
14 00860007188343 S12BP4 Transducer S12BP4 – 11 mm Neurosurgery Probe Transducer S12BP4 FUJIFILM HEALTHCARE AMERICAS CORPORATION
15 00860007188336 UST-52114P-B Ultrasound Brainpath Probe UST-52114P-B FUJIFILM HEALTHCARE AMERICAS CORPORATION
16 00860007188336 UST-52114P-B Ultrasound Brainpath Probe UST-52114P-B FUJIFILM HEALTHCARE AMERICAS CORPORATION
17 00860007188329 UST-9150 Ultrasound Laparoscopic Probe UST-9150 FUJIFILM HEALTHCARE AMERICAS CORPORATION
18 00860007188329 UST-9150 Ultrasound Laparoscopic Probe UST-9150 FUJIFILM HEALTHCARE AMERICAS CORPORATION
19 00860007188312 UST 5550-R Ultrasound Robotic Probe UST 5550-R FUJIFILM HEALTHCARE AMERICAS CORPORATION
20 00860007188312 UST 5550-R Ultrasound Robotic Probe UST 5550-R FUJIFILM HEALTHCARE AMERICAS CORPORATION
21 00860007188305 C9150LA 4-way Laparoscopic Ultrasound Transducer/Smart Connector C9150LA FUJIFILM HEALTHCARE AMERICAS CORPORATION
22 00860007188305 C9150LA 4-way Laparoscopic Ultrasound Transducer/Smart Connector C9150LA FUJIFILM HEALTHCARE AMERICAS CORPORATION
23 00860003700853 HS2100SS HS2100SS Hays Innovations Sterile Short US Probe Cover Kit Hays Inc HAYS, INC.
24 00860003024102 69-10050 AiM Vascular Mapping Kit AiM Accuracy In Marking System AIM MEDICAL TECHNOLOGIES, LLC
25 00860001239355 100009 SonoVision Ultrasound Imaging Console SonoVision TISSUE DIFFERENTIATION INTELLIGENCE LLC
26 00860001239348 100005 Beluga1 Imaging Probe Beluga1 TISSUE DIFFERENTIATION INTELLIGENCE LLC
27 00860000879842 300L 300L System, Imaging, Pulsed Echo, Ultrasonic Sonon HEALCERION CO., LTD.
28 00860000879835 300L 300L System, Imaging, Pulsed Doppler, Ultrasonic Sonon HEALCERION CO., LTD.
29 00860000879828 300L 300L Transducer, Ultrasonic, Diagnostic Helcerion HEALCERION CO., LTD.
30 00860000879811 300C 300C System, Imaging, Pulse Echo, Ultrasonics Sonon HEALCERION CO., LTD.
31 00860000879804 300C 300C Transducer, Ultrasonic, Diagnostic Sonon HEALCERION CO., LTD.
32 00860000784856 LQ-A3D1 A hand-held noninvasive component of an ultrasound imaging assembly designed to A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device. Convex 3D Array LINKQUEST INC.
33 00860000784849 LQ-A3S1 A hand-held noninvasive component of an ultrasound imaging assembly designed to A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device. Phase Array LINKQUEST INC.
34 00860000784832 LQ-E8C1 An invasive component of an ultrasound imaging assembly designed to be positione An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It is intended for use with a dedicated ultrasound system with dedicated software installed. This is a reusable device. MicroConvex Array LINKQUEST INC.
35 00860000784825 LQ-A3C1 A hand-held noninvasive component of an ultrasound imaging assembly designed to A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device. Convex Array LINKQUEST INC.
36 00860000784818 LQ-A8L1 A hand-held noninvasive component of an ultrasound imaging assembly designed to A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device. Linear Array LINKQUEST INC.
37 00860000784801 Model SQ860 A devices designed to collect, display, and analyse ultrasound images during a v 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. LinkQuest Diagnostic Ultrasound System and Transducers LINKQUEST INC.
38 00859297006079 3.5UltrasoundProbeCover(720) A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for 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. Kiltex Corporation KILTEX CORPORATION
39 00859297006062 3.5UltrasoundProbeCover(500) A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for 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. Kiltex Corpoartion KILTEX CORPORATION
40 00859297006055 3.5UltrasoundProbeCover(144) A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for 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. Kiltex Corporation KILTEX CORPORATION
41 00859297006048 3.5UltrasoundProbeCover(100) A non-sterile sheath 3.5cm x 20cm intended to be used as a physical barrier for 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. Kiltex Corporation KILTEX CORPORATION
42 00859297006031 2.6UltrasoundProbeCover(500) A non-sterile sheath 2.6cm x 20cm intended to be used as a physical barrier for 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. Kiltex Corporation KILTEX CORPORATION
43 00859297006024 2.6UltrasoundProbeCover(100) A non-sterile sheath 2.6cm x 20cm intended to be used as a physical barrier for 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. Kiltex Corporation KILTEX CORPORATION
44 00859297006017 2.0UltrasoundProbeCover(500) A non-sterile sheath 2.0cm x 20cm intended to be used as a physical barrier for 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. Kiltex Corporation KILTEX CORPORATION
45 00859297006000 2.0UltrasoundProbeCover(100) A non-sterile sheath (2.0cm x 20cm) intended to be used as a physical barrier fo 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. Kiltex Corporation KILTEX CORPORATION
46 00858703006269 32060 Ultrasonic Gel Ultraphonic, 5 Liter w/ bottle ACCELERATED CARE PLUS CORP
47 00858703006252 45539 Ultrasound Gel Ultraphonic (250ml Bottle) ACCELERATED CARE PLUS CORP
48 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. TVC Integrated Imaging System™ INFRAREDX, INC.
49 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. Makoto Intravascular Imaging System™ INFRAREDX, INC.
50 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. TVC Imaging System™ INFRAREDX, INC.