Other products from "VERATHON INC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00879123006400 BFlex™ 5.8 0570-0381 EOQ Bronchoscope (Flexible Or Rigid) 2 GlideScope®
2 00879123006394 BFlex™ 3.8 0570-0380 EOQ Bronchoscope (Flexible Or Rigid) 2 GlideScope®
3 00879123006332 BFlex™ 5.0 0570-0374 EOQ Bronchoscope (Flexible Or Rigid) 2 GlideScope®
4 00879123006134 QuickPrint 0900-1238 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 ScanPoint®
5 00879123006127 ScanPoint® IYO System, Imaging, Pulsed Echo, Ultrasonic 2 ScanPoint®
6 00879123004239 ScanPoint Local Client 0900-1009 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 ScanPoint®
7 00879123001641 Docking Station 0570-0168 IYO System, Imaging, Pulsed Echo, Ultrasonic ScanPoint®
8 00879123005526 BVI 9400 0570-0190 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
9 00879123002570 BVI 3000 0800-0167 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
10 00879123005564 BVI 6000 Series 0570-0355 IYO,ITX System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 BladderScan®
11 00879123008237 i10™ E570-0413 ITX Transducer, Ultrasonic, Diagnostic 2 BladderScan®
12 00879123008145 i10™ 0620-1083 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
13 00879123008015 Prime Plus™ E570-0395 BladderScan® Prime Plus™ Probe, Probe Exchange ITX Transducer, Ultrasonic, Diagnostic 2 BladderScan®
14 00879123007896 i10™ 0270-1014 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
15 00879123007537 BFlex™ 2.8 0570-0419 EOQ Bronchoscope (Flexible Or Rigid) 2 GlideScope®
16 00879123007445 i10™ 0570-0413 ITX Transducer, Ultrasonic, Diagnostic 2 BladderScan®
17 00879123007438 i10™ 0570-0412 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
18 00879123007414 i10™ 0800-0631 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
19 00879123006493 Prime Plus™ 0570-0395 BladderScan® Prime Plus™ Probe ITX Transducer, Ultrasonic, Diagnostic BladderScan®
20 00879123006486 Prime Plus™ 0570-0394 BladderScan® Prime Plus™ Console IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
21 00879123006172 Pediatric Phantom 0620-0273 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
22 00879123006141 BVI 6000 Series 0400-0109 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
23 00879123005755 Prime 0400-0130 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
24 00879123005663 BVI 3000 0400-0132 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
25 00879123005571 BVI 6000 Series 0570-0354 IYO,ITX System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic 2 BladderScan®
26 00879123005533 BVI 3000 0570-0090 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
27 00879123005496 Prime 0620-0739 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
28 00879123005168 Prime 0400-0126 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
29 00879123004598 Prime 0800-0532 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
30 00879123004505 Prime 0570-0347 ITX Transducer, Ultrasonic, Diagnostic 2 BladderScan®
31 00879123004499 Prime 0570-0346 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
32 00879123002976 BVI 9400 0570-0351 ITX Transducer, Ultrasonic, Diagnostic 2 BladderScan®
33 00879123002969 BVI 9400 0570-0193 ITX Transducer, Ultrasonic, Diagnostic 2 BladderScan®
34 00879123002631 BVI 9400 0800-0322 ITX Transducer, Ultrasonic, Diagnostic 2 BladderScan®
35 00879123002594 BVI 3000 0800-0245 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
36 00879123002525 Training Phantom 0620-0274 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
37 00879123002518 BVI 6000 Series 0620-0225 IYO System, Imaging, Pulsed Echo, Ultrasonic BladderScan®
38 00879123002501 BVI 3000 0620-0156 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
39 00879123002297 BVI 3000 0570-0091 ITX Transducer, Ultrasonic, Diagnostic BladderScan®
40 00879123002259 BVI 9400 0400-0066 ITX Transducer, Ultrasonic, Diagnostic 2 BladderScan®
41 00879123002235 BVI 3000 0400-0039 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
42 00879123001962 Tissue-Equivalent Phantom 0620-0068 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
43 00879123001948 BVI 9400 0620-0340 ITX Transducer, Ultrasonic, Diagnostic 2 BladderScan®
44 00879123001634 BVI 6000 Series 0570-0155 IYO System, Imaging, Pulsed Echo, Ultrasonic BladderScan®
45 00879123001511 i10™ 0400-0157 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
46 10879123005141 Prime 0270-0870 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
47 10879123004892 BVI 6000 Series 0270-0791 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
48 10879123004861 BVI 6000 Series 0270-0788 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
49 10879123004755 BVI 3000 0270-0303 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
50 10879123003659 BVI 9400 U270-0404 IYO System, Imaging, Pulsed Echo, Ultrasonic 2 BladderScan®
Other products with the same Product Code "IYO"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00869209000231 PD-010-0007 PD-010-0007 The BBS Revolution™ device is an automated bladder volume measurement device. AttendantⓇ Prodigy™ Bladder Scanner DBMEDX INC.
2 00869209000224 PD-040-0014 PD-040-0014 Single pack dBsonx ultrasound gel to be used with the BBS Revolution (TM) bladder scanner dBsonx™ DBMEDX INC.
3 00869209000200 PD-010-0002 PD-010-0002 The BBS Revolution™ device is an automated bladder volume measurement device. BBS Revolution™ DBMEDX INC.
4 00869047000448 C9150LA Ultrasound transducer HITACHI HEALTHCARE AMERICAS FUJIFILM HEALTHCARE AMERICAS CORPORATION
5 00869047000424 UST-52114P-B Ultrasound Transducer HITACHI HEALTHCARE AMERICAS FUJIFILM HEALTHCARE AMERICAS CORPORATION
6 00869047000417 UST-9150 Ultrasound transducer HITACHI HEALTHCARE AMERICAS FUJIFILM HEALTHCARE AMERICAS CORPORATION
7 00869047000400 UST-5550-R Ultrasound Transducer HITACHI HEALTHCARE AMERICAS FUJIFILM HEALTHCARE AMERICAS CORPORATION
8 00866646000305 490-00183-02, 490-00189-02 LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter BUTTERFLY NETWORK, INC.
9 00866646000299 490-00192-02 USB-C CABLE ASSEMBLY, USB 3.1 GEN 1, 1.50 meter USB-C CABLE ASSEMBLY, USB 3.1 GEN 1, 1.50 meter BUTTERFLY NETWORK, INC.
10 00866646000282 490-00187-02 USB-C CABLE ASSEMBLY, USB 2.0, 1.50 meter USB-C CABLE ASSEMBLY, USB 2.0, 1.50 meter BUTTERFLY NETWORK, INC.
11 00866646000275 490-00183-02, 490-00189-02 LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter BUTTERFLY NETWORK, INC.
12 00866646000268 WTD1A05 BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT BUTTERFLY NETWORK, INC.
13 00866646000251 490-00183-01, 490-00189-01 LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.00 meter LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.00 meter BUTTERFLY NETWORK, INC.
14 00866646000244 490-00183-00, 490-00189-00 LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter BUTTERFLY NETWORK, INC.
15 00866646000237 490-00187-01 USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter BUTTERFLY NETWORK, INC.
16 00866646000220 490-00187-00 USB-C CABLE ASSEMBLY, USB 2.0, 1.25 meter USB-C CABLE ASSEMBLY, USB 2.0, 1.25 meter BUTTERFLY NETWORK, INC.
17 00866646000213 850-20014 BUTTERFLY iQ+ BUTTERFLY iQ+ BUTTERFLY NETWORK, INC.
18 00866646000206 Butterfly iQ Portable Ultrasound System Butterfly Network, Inc. BUTTERFLY NETWORK, INC.
19 00863522000008 SOFIA SOFIA IVU IMAGING CORPORATION
20 00861589000139 ZHH ImaCor IMACOR INC
21 00861589000115 EVO 1 Ultrasound Machine for use with ClariTEE probe ImaCor Inc. IMACOR INC
22 00860008461223 uREzpocus M Ultrasonic pulsed doppler imaging system - MicroConvex array uREzpocus NORLAND AT SWISSRAY
23 00860008461216 uREzpocus H Ultrasonic pulsed doppler imaging system - uREzpocus H uREzpocus NORLAND AT SWISSRAY
24 00860008461209 uREzpocus C-EMS Ultrasonic pulsed doppler imaging system - Convex HD array uREzpocus NORLAND AT SWISSRAY
25 00860007188343 S12BP4 Transducer S12BP4 – 11 mm Neurosurgery Probe Transducer S12BP4 FUJIFILM HEALTHCARE AMERICAS CORPORATION
26 00860007188336 UST-52114P-B Ultrasound Brainpath Probe UST-52114P-B FUJIFILM HEALTHCARE AMERICAS CORPORATION
27 00860007188329 UST-9150 Ultrasound Laparoscopic Probe UST-9150 FUJIFILM HEALTHCARE AMERICAS CORPORATION
28 00860007188312 UST 5550-R Ultrasound Robotic Probe UST 5550-R FUJIFILM HEALTHCARE AMERICAS CORPORATION
29 00860007188305 C9150LA 4-way Laparoscopic Ultrasound Transducer/Smart Connector C9150LA FUJIFILM HEALTHCARE AMERICAS CORPORATION
30 00860001239355 100009 SonoVision Ultrasound Imaging Console SonoVision TISSUE DIFFERENTIATION INTELLIGENCE LLC
31 00860000879842 300L 300L System, Imaging, Pulsed Echo, Ultrasonic Sonon HEALCERION CO., LTD.
32 00860000879835 300L 300L System, Imaging, Pulsed Doppler, Ultrasonic Sonon HEALCERION CO., LTD.
33 00860000879828 300L 300L Transducer, Ultrasonic, Diagnostic Helcerion HEALCERION CO., LTD.
34 00860000879804 300C 300C Transducer, Ultrasonic, Diagnostic Sonon HEALCERION CO., LTD.
35 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.
36 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
37 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
38 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
39 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
40 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
41 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
42 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
43 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
44 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.
45 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.
46 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.
47 00857595006234 TVC-C195-42 TVC-C195-42 The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) is a single use, dispo 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. Dualpro™ IVUS+NIRS Imaging Catheter Kit INFRAREDX, INC.
48 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. TVC Insight XB™ INFRAREDX, INC.
49 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. TVC Insight™ INFRAREDX, INC.
50 00857595006005 TVC-MC8-B1 TVC-MC8-B1 Individual Sterile Barrier for TVC-MC8 or TVC-MC9 System Controller TVC Controller Sterile Barrier INFRAREDX, INC.