| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00840682121651 | Extend | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | Vscan | ||
| 2 | 00840682147071 | Air for iOS | Vscan Air for iOS | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vscan | |
| 3 | 00840682147484 | Air CL A1 | Vscan Air CL A1 | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Vscan | |
| 4 | 00840682147101 | Air for Android | Vscan Air for Android | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vscan | |
| 5 | 00840682115766 | P2D KE100005 | IYN,IYO,LLZ,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,System, image processing, radiological,Transducer, ultrasonic, diagnostic | 2 | NA | ||
| 6 | 00840682115759 | P6D-RS | IYO,LLZ,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, image processing, radiological, System, imaging, pulsed echo, ultrasonic,System, image processing, radiological,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | NA | ||
| 7 | 00840682115735 | 6Tc-RS | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | NA | ||
| 8 | 00840682115728 | 9T-RS | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | NA | ||
| 9 | 00840682115704 | P6D | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | NA | ||
| 10 | 00840682115681 | 6VT-D KN100110 | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | NA | ||
| 11 | 00840682115650 | 6VT-D | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | NA | ||
| 12 | 00840682115636 | 9T | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | NA | ||
| 13 | 00840682115612 | P2D | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | NA | ||
| 14 | 00840682115599 | P2D-RS | ITX,IYN,LLZ,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, image processing, radiological,System, imaging, pulsed echo, ultrasonic | 2 | NA | ||
| 15 | 00840682115582 | 6Tc | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | NA | ||
| 16 | 00840682115384 | Gateway v.1.4 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Vscan | ||
| 17 | 00840682107891 | Dual Probe | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vscan | ||
| 18 | 00840682107853 | v1.2 | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vscan | ||
| 19 | 00195278388483 | 9VT-D | KN100130 | 9VT-D Probe | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | NA |
| 20 | 00840682146883 | Software Only v204 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 21 | 00840682146876 | Plug-in v204 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 22 | 00840682104333 | Plug-in v201 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 23 | 00840682103961 | Software Only v201 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 24 | 00840682141703 | Software Only v203 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 25 | 00840682141697 | Plug-in v203 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 26 | 00840682123518 | Plug-in v202 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 27 | 00840682123501 | Software Only v202 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 28 | 00840682121095 | Software Only v113 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 29 | 00195278504326 | Plug-in v206 | MD EchoPAC Plug-in v206 | QIH,LLZ | Automated Radiological Image Processing Software,System, image processing, radiological | 2 | EchoPAC | |
| 30 | 00195278504302 | Software Only v206 | MD EchoPAC Software Only v206 | QIH,LLZ | Automated Radiological Image Processing Software,System, image processing, radiological | 2 | EchoPAC | |
| 31 | 00840682146678 | E90 v204 with OLED | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 32 | 00840682146661 | E80 v204 with LCD | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 33 | 00840682146982 | S70N v204 | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 34 | 00840682123365 | S60N v202CH | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 35 | 00840682123341 | S70N v202CH | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 36 | 00840682146975 | S60N v204CH | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 37 | 00840682146968 | S70N v204CH | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | ||
| 38 | 00840682146920 | S60N v204 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | ||
| 39 | 00840682147064 | E v203 to v204 UPG | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 40 | 00840682146692 | E90 v204 with LCD | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 41 | 00840682146685 | E95 v204 with LCD | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 42 | 00840682147156 | S v203 to v204 UPG | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | ||
| 43 | 00840682146654 | E95 v204 with OLED | Vivid E95 v204 with OLED | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | |
| 44 | 00840682146647 | E80 v204 with OLED | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 45 | 00840682143936 | S v202 to v203 UPG | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | ||
| 46 | 00840682142885 | S70N v203 | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | ||
| 47 | 00840682142861 | S60N v203 | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 48 | 00840682141734 | E80 v203 with LCD | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 49 | 00840682141727 | E90 v203 with LCD | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 50 | 00840682141710 | E95 v203 with LCD | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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. |
| 2 | 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. |
| 3 | 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. |
| 4 | 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. |
| 5 | 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. |
| 6 | 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. |
| 7 | 00857595006005 | TVC-MC8-B1 | TVC-MC8-B1 | Individual Sterile Barrier for TVC-MC8 or TVC-MC9 System Controller | TVC Controller Sterile Barrier | INFRAREDX, INC. |
| 8 | 00857377006353 | DGH 555B Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range. | Pachette 4 Calbox | DGH TECHNOLOGY INC. | |
| 9 | 00857377006346 | DGH 555 Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range. | Pachette 3 Calbox | DGH TECHNOLOGY INC. | |
| 10 | 00857377006339 | DGH 55B Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range. | Pachmate 2 Calbox | DGH TECHNOLOGY INC. | |
| 11 | 00857377006322 | DGH 55 Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range. | Pachmate Calbox | DGH TECHNOLOGY INC. | |
| 12 | 00857377006315 | MM Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range. | Multiple Measurement Calbox | DGH TECHNOLOGY INC. | |
| 13 | 00857377006308 | SM Calbox | The pachymeter calbox is an accessory that connects to a pachymeter and creates The pachymeter calbox is an accessory that connects to a pachymeter and creates a single precise, predetermined electronic pulse. The pachymeter measures the pulse, and the operator verifies that the measurement value is within an acceptable range. | Single Measurement Calbox | DGH TECHNOLOGY INC. | |
| 14 | 00857377006247 | DET 2006 | The DET2006 is a small, removable probe containing an ultrasonic transducer. Thi The DET2006 is a small, removable probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices. | DET 2006 Detachable Pachymeter Probe | DGH TECHNOLOGY INC. | |
| 15 | 00857377006230 | DGH 6006 | The DGH6006 is a corded probe containing an ultrasonic transducer. This probe is The DGH6006 is a corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic A-Scan devices. | DGH 6006 Corded A-Scan Probe | DGH TECHNOLOGY INC. | |
| 16 | 00857377006223 | DGH 3006 | The DGH3006 is a corded probe containing an ultrasonic transducer. This probe is The DGH3006 is a corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic A-Scan devices. | DGH 3006 Corded A-Scan Probe | DGH TECHNOLOGY INC. | |
| 17 | 00857377006216 | DGH 2006 | The DGH2006 is an angled corded probe containing an ultrasonic transducer. This The DGH2006 is an angled corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices. | DGH 2006 Corded Pachymeter Probe | DGH TECHNOLOGY INC. | |
| 18 | 00857377006209 | DGH 1006 | The DGH1006 is a straight corded probe containing an ultrasonic transducer. This The DGH1006 is a straight corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices. | DGH 1006 Corded Pachymeter Probe | DGH TECHNOLOGY INC. | |
| 19 | 00857377006162 | DGH1500-50 | The DGH1500-50 is a 50 MHz ultrasonic element that is for use with the DGH1500 UBM Probe. | UBM 50 MHz Transducer | DGH TECHNOLOGY INC. | |
| 20 | 00857377006162 | DGH1500-50 | The DGH1500-50 is a 50 MHz ultrasonic element that is for use with the DGH1500 UBM Probe. | UBM 50 MHz Transducer | DGH TECHNOLOGY INC. | |
| 21 | 00857377006155 | DGH1500-35 | The DGH1500-35 is a 35 MHz ultrasonic element that is for use with the DGH1500 UBM Probe. | UBM 35 MHz Transducer | DGH TECHNOLOGY INC. | |
| 22 | 00857377006148 | DGH1500 | The DGH1500 is a single-element mechanical sector UBM probe. This probe connects The DGH1500 is a single-element mechanical sector UBM probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. | UBM Probe | DGH TECHNOLOGY INC. | |
| 23 | 00857377006148 | DGH1500 | The DGH1500 is a single-element mechanical sector UBM probe. This probe connects The DGH1500 is a single-element mechanical sector UBM probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. | UBM Probe | DGH TECHNOLOGY INC. | |
| 24 | 00857377006131 | DGH1912 | The DGH1912 is a single-element mechanical sector B-scan probe. This probe conne The DGH1912 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. | 12.5 MHz B-Scan Probe | DGH TECHNOLOGY INC. | |
| 25 | 00857377006131 | DGH1912 | The DGH1912 is a single-element mechanical sector B-scan probe. This probe conne The DGH1912 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. | 12.5 MHz B-Scan Probe | DGH TECHNOLOGY INC. | |
| 26 | 00857377006124 | DGH1920 | The DGH1920 is a single-element mechanical sector B-scan probe. This probe conne The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. | 20 MHz B-Scan Probe | DGH TECHNOLOGY INC. | |
| 27 | 00857377006124 | DGH1920 | The DGH1920 is a single-element mechanical sector B-scan probe. This probe conne The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. | 20 MHz B-Scan Probe | DGH TECHNOLOGY INC. | |
| 28 | 00857377006117 | Scanmate Flex | The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The system consists of three main components: an interface module with integrated probe holder, one or more ultrasonic probes, and the Scanmate software application. | Scanmate Flex USB Interface | DGH TECHNOLOGY INC. | |
| 29 | 00857377006117 | Scanmate Flex | The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The system consists of three main components: an interface module with integrated probe holder, one or more ultrasonic probes, and the Scanmate software application. | Scanmate Flex USB Interface | DGH TECHNOLOGY INC. | |
| 30 | 00857377006100 | DGH 8000 | The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that co The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye. | Scanmate B | DGH TECHNOLOGY INC. | |
| 31 | 00857377006100 | DGH 8000 | The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that co The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye. | Scanmate B | DGH TECHNOLOGY INC. | |
| 32 | 00857377006094 | DGH 6000 | The DGH 6000 is a Portable Ultrasonic A-Scan. It is an electronic device that co The DGH 6000 is a Portable Ultrasonic A-Scan. It is an electronic device that connects to the user's PC via USB connection. It is a portable device that uses ultrasonic pulse technology to obtain axial length measurements of the human eye | Scanmate A | DGH TECHNOLOGY INC. | |
| 33 | 00857377006018 | DGH 555B | The DGH 555B is a Desktop Ultrasonic Pachymeter. It is a portable, battery-power The DGH 555B is a Desktop Ultrasonic Pachymeter. It is a portable, battery-powered electronic medical device that uses ultrasonic pulse technology to measure the thickness of the human cornea. | Pachette 4 | DGH TECHNOLOGY INC. | |
| 34 | 00857377006001 | DGH 55B | The DGH 55B is a Handheld Ultrasonic Pachymeter. It is a hand-held, battery-powe The DGH 55B is a Handheld Ultrasonic Pachymeter. It is a hand-held, battery-powered electronic medical device that uses ultrasonic pulse technology to measure the thickness of the human cornea. | Pachmate 2 | DGH TECHNOLOGY INC. | |
| 35 | 00857356008019 | T900-021 | Ultrasound Convex Transducer | mi-ultra CX | TRICE MEDICAL, INC. | |
| 36 | 00857356008019 | T900-021 | Ultrasound Convex Transducer | mi-ultra CX | TRICE MEDICAL, INC. | |
| 37 | 00857356008019 | T900-021 | Ultrasound Convex Transducer | mi-ultra CX | TRICE MEDICAL, INC. | |
| 38 | 00857356008002 | T900-020 | Ultrasound Linear Transducer | mi-ultra LR | TRICE MEDICAL, INC. | |
| 39 | 00857356008002 | T900-020 | Ultrasound Linear Transducer | mi-ultra LR | TRICE MEDICAL, INC. | |
| 40 | 00857356008002 | T900-020 | Ultrasound Linear Transducer | mi-ultra LR | TRICE MEDICAL, INC. | |
| 41 | 00857042007999 | 900000 | 900000 | AcQMap System | AcQMap | ACUTUS MEDICAL, INC. |
| 42 | 00857042007999 | 900000 | 900000 | AcQMap System | AcQMap | ACUTUS MEDICAL, INC. |
| 43 | 00857042007920 | 900100 | 900100 | AcQMap System Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
| 44 | 00857042007920 | 900100 | 900100 | AcQMap System Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
| 45 | 00857042007876 | 800727 | 800727 | AcQMap to DiamondTemp Generator Adapter | DiamondTemp Generator Adapter | ACUTUS MEDICAL, INC. |
| 46 | 00857042007876 | 800727 | 800727 | AcQMap to DiamondTemp Generator Adapter | DiamondTemp Generator Adapter | ACUTUS MEDICAL, INC. |
| 47 | 00857042007562 | 800605 | 800605 | AcQMap Patient Electrode Kit | AcQMap | ACUTUS MEDICAL, INC. |
| 48 | 00857042007562 | 800605 | 800605 | AcQMap Patient Electrode Kit | AcQMap | ACUTUS MEDICAL, INC. |
| 49 | 00857042007425 | 800604 | 800604 | AcQMap Auxiliary Interface Box, Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
| 50 | 00857042007425 | 800604 | 800604 | AcQMap Auxiliary Interface Box, Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |