No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00884838108899 | 300007314091 | HD 8Ch WRIST ARRAY (Receive Only) | MOS | Coil, Magnetic Resonance, Specialty | 2 | GE HEALTHCARE | |
2 | 00884838055322 | 781341 | Magnetic Resonance Equipment | LNI,LNH | System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging | 2 | Ingenia 1.5T | |
3 | 00884838106970 | 6 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
4 | 00884838104570 | ClarifEye - 1 | 002120 | Software medical device. Intended for use by professional healthcare providers a Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy. | OWB,LLZ,JAK,OLO | Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological, Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological,System, X-Ray, Tomography, Computed,Orthopedic Stereotaxic Instrument | 2 | ClarifEye |
5 | 00884838101890 | StentBoost Live - 2 | 001017 | Software medical device, used with a Philips Interventional X-Ray System. Provid Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents. | OWB,LLZ | Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological | 2 | StentBoost Live |
6 | 00884838100107 | 5 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
7 | 00884838099272 | Azurion 7 B20 | 722226 | Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch fl Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ceiling-mounted lateral stand (12-inch or 15-inch flat detector) and optional interface for an OR table. | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Azurion |
8 | 00884838095250 | 4.2 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
9 | 00884838085268 | Azurion 7 M20 | 722079 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane syst Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inch flat detector. Optionally the ceiling-mounted configuration has an interface for an OR table | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Azurion |
10 | 00884838085220 | 2.2 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular | |
11 | 00884838093072 | 4.1 | 98960612681X | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
12 | 00884838091429 | 3.2 | 98960612660X | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
13 | 00884838090668 | Onvision system | 453561943492 | Intended to be used during peripheral nerve block procedures. Tracks the positio Intended to be used during peripheral nerve block procedures. Tracks the position of the B.Braun Onvision needle tip position on the ultrasound image by overlaying a circle at the given location. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Onvision system |
14 | 00884838087460 | 3.1 | 98960612483X | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
15 | 00884838085251 | Azurion 7 M12 | 722078 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane syst Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inch flat detector. | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Azurion |
16 | 00884838085770 | 2.3 | 98960612341x | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
17 | 00884838084544 | Philips Hemodynamic Application - 1 | 002010 | Software medical device. Intended for use by professional healthcare providers f Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment. | MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | Philips Hemodynamic Application |
18 | 00884838080812 | StentBoost Live - 1 | 001017 | Software medical device, used with a Philips Interventional X-Ray System. Provid Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents. | OWB,LLZ | Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological | 2 | StentBoost Live |
19 | 00884838076730 | 1.2 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular | |
20 | 00884838075214 | 2.1 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular | |
21 | 00884838059269 | StentBoost - 4 | 001007 | Software medical device, used with a Philips Interventional X-Ray System. Provid Software medical device, used with a Philips Interventional X-Ray System. Provides high resolution visualization of stents in vessels. Supports the user in placing and deploying stents. | OWB,LLZ | Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological | 2 | StentBoost |
22 | 00884838059238 | MR-CT Roadmap - 1 | 001004 | Software medical device, used with a Philips Interventional X-Ray System. Extens Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D-RA. Provides live 3D image guidance for navigating endovascular devices through vascular structures. | OWB,LLZ,JAK | Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological, Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological,System, X-Ray, Tomography, Computed | 2 | MR-CT Roadmap |
23 | 00884838059191 | Interventional Workspot - 1 | 001000 | Software medical device hosting platform, used with a Philips Interventional X-R Software medical device hosting platform, used with a Philips Interventional X-Ray System. Provides common functionalities (e.g. import / export, data handling) for other software medical devices. | LLZ,OWB | System, Image Processing, Radiological,Interventional Fluoroscopic X-Ray System | 2 | Interventional Workspot |
24 | 00884838083325 | 728231 | JAK | System, x-ray, tomography, computed | 2 | Brilliance CT | ||
25 | 00884838114388 | 300009321831 | Medial Array Coil VT | MOS | Coil, Magnetic Resonance, Specialty | 2 | DUNLEE SENITNELLE | |
26 | 00884838108646 | Ingenia 1.5T | 782140 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
27 | 00884838108639 | Ingenia Ambition S | 782139 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
28 | 00884838108622 | Ingenia Ambition X | 782138 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
29 | 00884838108615 | Ingenia Elition S | 782137 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
30 | 00884838108608 | Ingenia Elition X | 782136 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
31 | 00884838104129 | Ingenia Elition X | 782119 | The Ingenia Elition X with the gradient and RF designs, as well as Compressed SE The Ingenia Elition X with the gradient and RF designs, as well as Compressed SENSE delivers on superb image quality, improves patient handling setup time and combines this with accelerations in both 2D- and 3D scanning. | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
32 | 00884838099715 | Ingenia 1.5T | 781315 | LNH,LNI | System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic | 2 | Ingenia | |
33 | 00884838099500 | HA FlexTrak II | 989710008732 | The HA FlexTrak II is Height-adjustable to facilitate easy patient transfer and The HA FlexTrak II is Height-adjustable to facilitate easy patient transfer and allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
34 | 00884838099494 | Tabletop extender | 989603008792 | A moveable tabletop which combined with the standard table top enables a maximum A moveable tabletop which combined with the standard table top enables a maximum field of view of 200cm. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
35 | 00884838099487 | Trolley | 989603008226 | The Patient Trolley Frame is a stainless steel frame with four wheels for easy t The Patient Trolley Frame is a stainless steel frame with four wheels for easy transportation of the patient positioned on the system's tabletop. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
36 | 00884838099470 | HA FlexTrak | 989710006412 | The HA FlexTrak is Height-adjustable to facilitate easy patient transfer and all The HA FlexTrak is Height-adjustable to facilitate easy patient transfer and allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
37 | 00884838099463 | FlexTrak | 989710006402 | The FlexTrak allows patient preparation for an examination while the previous pa The FlexTrak allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
38 | 00884838099456 | Acoustic Hood | 989603022784 | "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and the SENSE Pediatric Body/Cardiac coil and their mattresses.The acoustic will provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations.Premature patients are scanned while their acoustic sensory system is still in development and should be protected. Very small children will not always tolerate a headset." | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
39 | 00884838099449 | Acoustic Hood | 989603020982 | "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and the SENSE Pediatric Body/Cardiac coil and their mattresses.The acoustic will provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations.Premature patients are scanned while their acoustic sensory system is still in development and should be protected. Very small children will not always tolerate a headset." | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
40 | 00884838098343 | Ingenia Ambition S | 782108 | Ingenia Ambition S | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
41 | 00884838098336 | Ingenia Elition X | 782107 | Ingenia Elition X | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
42 | 00884838098329 | Ingenia Elition S | 782106 | Ingenia Elition S | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
43 | 00884838099340 | AltaTrack equipment | 4322 070 2535 X | The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FO The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and/or AltaTrack Catheter and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available.The AltaTrack equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component. | DQK | Computer, Diagnostic, Programmable | 2 | AltaTrack |
44 | 00884838099043 | Ingenia 1.5T | 782115 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
45 | 00884838098350 | Ingenia Ambition X | 782109 | Ingenia Ambition X | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
46 | 00884838095083 | Smartpath to dStream for 3.0T | 781270 | LNH,LNI | System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic | 2 | Ingenia | |
47 | 00884838098312 | Ingenia 3.0T CX | 782105 | We’ve designed Ingenia 3.0T CX with the performance that helps you explore with We’ve designed Ingenia 3.0T CX with the performance that helps you explore with confidence, perform advanced clinical imaging that supports referrals, and conduct routine imaging efficiently. Thanks in part to exceptional Qua | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
48 | 00884838098299 | Ingenia 3.0T | 782103 | Ingenia 3.0T | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
49 | 00884838098275 | Ingenia 1.5T | 782101 | Ingenia 1.5T | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
50 | 00884838095076 | Smartpath to dStream for 1.5T | 781260 | MRDD Equipment | LNI,LNH | System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging | 2 | Ingenia |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00884838105034 | 6 | 830230 | The Information Management System is a software to acquire, display, trend, stor The Information Management System is a software to acquire, display, trend, store, and transmit physiologic, hemodynamic, clinical, medical images, and other related data. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
2 | 00884838100084 | 5 | 830230 | The Xper Information Management System is used for acquiring, displaying, trendi The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
3 | 00884838099340 | AltaTrack equipment | 4322 070 2535 X | The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FO The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and/or AltaTrack Catheter and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available.The AltaTrack equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component. | AltaTrack | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
4 | 00884838098985 | 2.6 | 98960612834x | The information management system is intended for use under the direct supervisi The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic, hemodynamic, clinical, medical image and other related data. The system is capable of processing / analyzing information, such as multi-channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed. The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a standalone device. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
5 | 00884838095229 | 733015 | The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiologic The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP)procedures. The KODEX-EPD™ System provides information about the electrical activity of theheart and about catheter location during the procedure. The system can be used on patients who areeligible for a conventional electrophysiological procedure. | KODEX-EPD System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | |
6 | 00884838094840 | ST80i Stress Test System | 860343 | Philips ST80i Stress System | Stress | PHILIPS MEDICAL SYSTEMS HSG |
7 | 00884838093478 | IntelliSpace ECG Management System | 860426 | "Provides for the acquisition, processing, storage, and distribution for resting "Provides for the acquisition, processing, storage, and distribution for resting ECGs from Philips PageWriter cardiographs, IntelliVue Monitoring Systems, and Telemedicine Systems as well as for Philips stress and Holter reports. Non-Philips devices optionally supported. Application software only. Does not include Windows Server 2012 or SQL Server 2014. North America: Includes remote software installation in customer-supplied compliant environment. Base editions and base upgrades include standard implementation. Custom or incremental services are quoted by the SCS or local organization with a Statement of Work. International Markets: Implementation services are not included and are quoted separately." | IECG | PHILIPS MEDICAL SYSTEMS HSG |
8 | 00884838091771 | 2.5 | 98960612665x | The Xper Information Management System is used for acquiring, displaying, trendi The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
9 | 00884838090750 | B.01 | IECG | PHILIPS MEDICAL SYSTEMS HSG | ||
10 | 00884838087330 | 2.4 | 98960612482x | The Xper Information Management System is used for acquiring, displaying, trendi The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
11 | 00884838085213 | 2.3 | 98960612322x | The information management system is intended for use under the direct supervisi The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic/hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information, such as multi-channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
12 | 00884838081291 | 2.2 | 453564649781 | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | |
13 | 00884838070721 | 2.1 | 453564530681 | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | |
14 | 00884838070691 | 1.5 | 453564495001 | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | |
15 | 00884838032408 | B.01.00 | IECG | PHILIPS MEDICAL SYSTEMS HSG | ||
16 | 00884838030299 | 860343 | 860343 | Philips | PHILIPS MEDICAL SYSTEMS HSG | |
17 | 00869781000308 | Navik 3D v2.0 | 200-00668 | Navik 3D™ is a multi-component computer system that utilizes image processing me Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D) fluoroscopic (fluoro) images. In addition, body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals obtained from the patient recording and monitoring systems that already exist in the electrophysiology (EP) lab are digitized and displayed.Navik 3D utilizes data points from 3D catheter location and ECG-intracardiac EGM signals and uses this information to create and display 3D maps of the human heart. It does not require special catheters or patches, specially trained technicians, or fluoroscopy exposure beyond standard of care. | Navik 3D | APN HEALTH |
18 | 00869770000234 | K100A101X | ZIO SR ECG Monitoring Service | ZIO SR Patch | IRHYTHM TECHNOLOGIES, INC. | |
19 | 00869770000210 | A100A100X | ZIO AT ECG Monitoring Service | ZIO AT Patch | IRHYTHM TECHNOLOGIES, INC. | |
20 | 00869047000431 | 4.X.X | The VidiStar PACS & DICOM Viewer Software system is a picture archiving and comm The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet. | VidiStar PACS & DICOM Viewer Software | FUJIFILM HEALTHCARE AMERICAS CORPORATION | |
21 | 00860991000362 | 6.2 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
22 | 00860991000355 | 6.1 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
23 | 00860991000348 | 6.0 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Epiphany Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
24 | 00860991000331 | 5.4 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Epiphany Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
25 | 00860991000324 | 5.3 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Epiphany Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
26 | 00860991000317 | 5.2.0 | ECG Management System is a software only ECG management database that stores, di ECG Management System is a software only ECG management database that stores, displays, and prints high resolution ECG Data | Epiphany Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
27 | 00860991000300 | 5.1.0 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Epiphany Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
28 | 00860007954177 | VMCU1 | vMap Control Unit | VEKTOR MEDICAL, INC. | ||
29 | 00860007954108 | VMDISP1 | vMap Disposables | VEKTOR MEDICAL, INC. | ||
30 | 00857560008010 | 1.2.5 | 113-01003 | The HealthView ECG Manager is a computer system, used within a clinical network, The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review.The product does not modify the original ECG waveform and does not provide an automated ECG analysis. | HealthView ECG Manager | LUMEDX CORPORATION |
31 | 00857553006139 | D300 | D300 | Cardea SOLO PC Software - ECG analysis software (D300) | Cardea SOLO | CARDIAC INSIGHT, INC. |
32 | 00857553006092 | C300/D300 | C300/D300 | StealthView Software & Smart Cable - ECG analysis software (D300) and data trans StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300). | Stealth System S300 | CARDIAC INSIGHT, INC. |
33 | 00857042007999 | 900000 | 900000 | AcQMap System | AcQMap | ACUTUS MEDICAL, INC. |
34 | 00857042007920 | 900100 | 900100 | AcQMap System Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
35 | 00857042007876 | 800727 | 800727 | AcQMap to DiamondTemp Generator Adapter | DiamondTemp Generator Adapter | ACUTUS MEDICAL, INC. |
36 | 00857042007562 | 800605 | 800605 | AcQMap Patient Electrode Kit | AcQMap | ACUTUS MEDICAL, INC. |
37 | 00857042007425 | 800604 | 800604 | AcQMap Auxiliary Interface Box, Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
38 | 00857042007388 | 800531 | 800531 | Cable, AcQMap Surface ECG Output (AHA) Packaged | AcQMap | ACUTUS MEDICAL, INC. |
39 | 00857042007364 | 800405 | 800405 | POAG Cable MC-POAG-EC6/2 | AcQMap | ACUTUS MEDICAL, INC. |
40 | 00857042007357 | 800255 | 800255 | Workstation Cable | AcQMap | ACUTUS MEDICAL, INC. |
41 | 00857042007333 | 800601 | 800601 | Power Cord, Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
42 | 00857042007326 | 800505 | 800505 | AcQMap Ablation Reference Cable | AcQMap | ACUTUS MEDICAL, INC. |
43 | 00857042007319 | 800508 | 800508 | AcQMap Ablation Electrogram Cable | AcQMap | ACUTUS MEDICAL, INC. |
44 | 00857042007302 | 800422 | 800422 | AcQMap Auxiliary Interface Box | AcQMap | ACUTUS MEDICAL, INC. |
45 | 00857042007296 | 800500 | 800500 | AcQMap Console | AcQMap | ACUTUS MEDICAL, INC. |
46 | 00857042007289 | 800520 | 800520 | AcQMap Workstation | AcQMap | ACUTUS MEDICAL, INC. |
47 | 00857042007272 | 800523 | 800523 | AcQMap 2mm Pin Jumper St | AcQMap | ACUTUS MEDICAL, INC. |
48 | 00857042007265 | 800522 | 800522 | AcQMap ECG w/Snaps Cable | AcQMap | ACUTUS MEDICAL, INC. |
49 | 00857042007258 | 800524 | 800524 | AcQMap ECG POST Cable | AcQMap | ACUTUS MEDICAL, INC. |
50 | 00857042007241 | 800421 | 800421 | AcQMap ECG Input Cable | AcQMap | ACUTUS MEDICAL, INC. |