Other products from "TIDI PRODUCTS, LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00618125175277 20977FF Gems Positioning Aid Kits Ether Foam 1in x 1in x 1in 15 per Set KXJ Table, radiologic 2 Gems
2 00618125175659 33177 Gems Table Pads Gray Ester Foam Nylon 9.2in x 36in x .5in 1 per Each KXJ Table, radiologic 2 Gems
3 00618125175581 30176 Bionix Positioning Aid Kits Ether F-830, F-892 Top Coat 1in x 1in x 1in 1 per Each KXJ Table, radiologic 2 Bionix
4 00618125171170 25932 Gems Cradle Pads 16in x 15.63in x 1in 1 per Each KXJ Table, radiologic 2 Gems
5 00618125171095 25325 Gems Cradle Pads 16in x 88.25in x 1in 1 per Each KXJ Table, radiologic 2 Gems
6 00618125171040 24450 Gems Table Pads Gray 13.68in x 27.24in x 1.2in 1 per Each KXJ Table, radiologic 2 Gems
7 00618125171019 23800 Gems Positioning Aids - Head And Neck Gray Kit, Various Sizes 8 per Set KXJ Table, radiologic 2 Gems
8 00618125170982 23480 Gems Patient Positioners Various Various For Spine Surface Coils 3 per Set KXJ Table, radiologic 2 Gems
9 00618125170944 22633 Gems Positioning Aids - Leg Gray 6.72in x 11.5in x 6.72in 1 per Each KXJ Table, radiologic 2 Gems
10 00618125170883 21785 Gems Transfer Boards White Polyethylene 23in x 73in x .18in 1 per Each KXJ Table, radiologic 2 Gems
11 00618125170876 21515 Gems Table Pads 17in x 19in x .5in 1 per Each KXJ Table, radiologic 2 Gems
12 00618125170869 21428 Gems Table Pads 17in x 66in x .5in 1 per Each KXJ Table, radiologic 2 Gems
13 00618125170821 21308 Gems Straps White Vinyl 3.25in x 51in 1 per Each KXJ Table, radiologic 2 Gems
14 00618125170814 21235 Gems Straps Various Various 15.44in x 32in x 6in 1 per Each KXJ Table, radiologic 2 Gems
15 00618125170807 21234 Gems Straps Various Various 21.44in x 31.44in x 14in 1 per Each KXJ Table, radiologic 2 Gems
16 00618125170791 21198 Gems Sand Bags Blue Vinyl 8.5in x 14in 1 per Each KXJ Table, radiologic 2 Gems
17 00618125170784 20979FF Gems Positioning Aids - Leg Kit, Various Sizes 3 per Set KXJ Table, radiologic 2 Gems
18 00618125170760 20929F Gems Positioning Aids - Blocks 10.25in x 11in x 4.5in 1 per Each KXJ Table, radiologic 2 Gems
19 00618125170722 20810F Gems Positioning Aids - Leg 6in x 6in 1 per Each KXJ Table, radiologic 2 Gems
20 00618125170685 20705 Gems Straps Various Various Universal Fit 10 per Set KXJ Table, radiologic 2 Gems
21 00618125170661 20692F Gems Straps Various Various 6in x 46in 1 per Each KXJ Table, radiologic 2 Gems
22 00618125170654 20688 Gems Table Pads Gray 15.5in x 60in x 2in 1 per Each KXJ Table, radiologic 2 Gems
23 00618125170647 20676 Gems Positioning Aids - Wedges Kit, Various Sizes 12 per Set KXJ Table, radiologic 2 Gems
24 00618125170593 20603 Gems Positioning Aids - Blocks 3in x 5in x .88in 6 per Set KXJ Table, radiologic 2 Gems
25 00618125170586 20602 Gems Positioning Aids - Rectangles Gray 5.25in x 14.5in x .5in 1 per Each KXJ Table, radiologic 2 Gems
26 00618125170579 20601 Gems Positioning Aids - Rectangles Gray 14in x 14in x 1.3in 1 per Each KXJ Table, radiologic 2 Gems
27 00618125170562 20589 Gems Positioning Aids - Rectangles Gray 5.25in x 14.5in x 1in 1 per Each KXJ Table, radiologic 2 Gems
28 00618125170555 20588 Gems Positioning Aids - Rectangles Gray 3in x 14.5in x 1in 1 per Each KXJ Table, radiologic 2 Gems
29 00618125170548 20583 Gems Positioning Aids - Rectangles Gray 3in x 5in x .88in 1 per Each KXJ Table, radiologic 2 Gems
30 00618125170531 20582 Gems Positioning Aids - Rectangles Gray 14in x 24in x 2.5in 1 per Each KXJ Table, radiologic 2 Gems
31 00618125170524 20579 Gems Positioning Aids - Head And Neck Gray 3in x 7.25in x 2.5in 1 per Each KXJ Table, radiologic 2 Gems
32 00618125170517 20578 Gems Positioning Aids - Leg 12.5in x 16in x 7.5in 1 per Each KXJ Table, radiologic 2 Gems
33 00618125170500 20520 Gems Positioning Aids - Wedges Gray 1.75in x 4in x 14.5in 1 per Each KXJ Table, radiologic 2 Gems
34 00618125170494 20519 Gems Positioning Aids - Wedges Gray 3.78in x 8in x 10in 1 per Each KXJ Table, radiologic 2 Gems
35 00618125170487 20518 Gems Positioning Aids - Wedges Gray 10in x 10in x 14in 1 per Each KXJ Table, radiologic 2 Gems
36 00618125170470 20517 Gems Positioning Aids - Wedges Gray 3in x 10in x 10in 1 per Each KXJ Table, radiologic 2 Gems
37 00618125170425 20326 Gems Positioning Aids - Wedges 9in x 9in x 9in 2 per Set KXJ Table, radiologic 2 Gems
38 00618125170418 20324 Gems Positioning Aids - Wedges 9in x 9in x 3in 2 per Set KXJ Table, radiologic 2 Gems
39 00618125170401 20272 Gems Straps Various Various 14in x 46in 1 per Each KXJ Table, radiologic 2 Gems
40 00618125170371 20048 Gems Straps Various Various Fits CT Hilight, Hispeed Advantage, CT 8800 AND CT 3 per Set KXJ Table, radiologic 2 Gems
41 00618125167869 30346 Gems Straps Gray 2in x 85in x 1in 1 per Each KXJ Table, radiologic 2 Gems
42 00618125167661 32964 Gems Straps White 1.5in x 30in x 1in 1 per Each KXJ Table, radiologic 2 Gems
43 00618125167623 21332 Gems Positioning Aids - Leg Ester Foam 15.5in x 30.5in x 10.65in 1 per Each KXJ Table, radiologic 2 Gems
44 00618125167531 30416 Gems Positioning Aid Kits Ester Foam 1in x 1in x 1in 13 per Set KXJ Table, radiologic 2 Gems
45 00618125167487 20690 Gems Positioning Aids - Leg Ether Foam 1in x 1in x 1in 2 per Set KXJ Table, radiologic 2 Gems
46 00618125166466 27665 Bionix Ether Foam 1in x 12in x 1in 1 per Each KXJ Table, radiologic 2 Bionix
47 00618125166275 27837 Bionix Positioning Aids - Leg Ether Foam 4.04in x 5in x 2.83in 2 per Set KXJ Table, radiologic 2 Bionix
48 00618125165971 27590 Bionix Positioning Aids - Body Ether Foam 7.09in x 11.5in x 2.75in 1 per Each KXJ Table, radiologic 2 Bionix
49 00618125165636 33116 Bionix Positioning Aids - Wedges Ether Foam 5in x 15in x 5in 1 per Each KXJ Table, radiologic 2 Bionix
50 00618125164882 32501 Bionix Positioning Aids - Leg Ether Foam 4.04in x 5in x 2.83in 2 per Set KXJ Table, radiologic 2 Bionix
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.