Other products from "VEKTOR MEDICAL, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00860007954177 VMCU1 DQK Computer, Diagnostic, Programmable 2 vMap Control Unit
Other products with the same Product Code "DQK"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 04250903202469 v2.6 Global 2092504-260 The CardioDay Holter Analysis Software is designed for the acquisition, analysis The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data.Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. CardioDay GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
2 04250903202445 Global SP04 2092504-254 The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, ana The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data.Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay V2.5 system is intended to be used by trained operatorsunder the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. CardioDay V2.5 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
3 04250903200144 Global 2092504-001 The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, ana The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data.Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay V2.5 system is intended to be used by trained operatorsunder the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. CardioDay V 2.5 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
4 04056869010205 11007642 Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" descri Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22 Sensis Vibe Combo SIEMENS HEALTHCARE GMBH
5 04056869010199 11007641 Device originally cleared as "Sensis"; Name change to "Sensis Vibe Hemo" describ Device originally cleared as "Sensis"; Name change to "Sensis Vibe Hemo" described in NFJ filed on 2016-03-22 Sensis Vibe Hemo SIEMENS HEALTHCARE GMBH
6 04056869010144 10764562 Sensis Lite SIEMENS HEALTHCARE GMBH
7 04056869010137 10764561 Sensis SIEMENS HEALTHCARE GMBH
8 03770019196007 A001 A001 Cardiac Electrophysiology mapping tool VX1 SUBSTRATE HD
9 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.
10 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.
11 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.
12 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.
13 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.
14 00884838094840 ST80i Stress Test System 860343 Philips ST80i Stress System Stress PHILIPS MEDICAL SYSTEMS HSG
15 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
16 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.
17 00884838090750 B.01 IECG PHILIPS MEDICAL SYSTEMS HSG
18 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.
19 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.
20 00884838081291 2.2 453564649781 Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
21 00884838070721 2.1 453564530681 Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
22 00884838070691 1.5 453564495001 Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
23 00884838032408 B.01.00 IECG PHILIPS MEDICAL SYSTEMS HSG
24 00884838030299 860343 860343 Philips PHILIPS MEDICAL SYSTEMS HSG
25 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
26 00869770000234 K100A101X ZIO SR ECG Monitoring Service ZIO SR Patch IRHYTHM TECHNOLOGIES, INC.
27 00869770000210 A100A100X ZIO AT ECG Monitoring Service ZIO AT Patch IRHYTHM TECHNOLOGIES, INC.
28 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
29 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
30 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
31 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
32 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
33 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
34 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
35 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
36 00860007954177 VMCU1 vMap Control Unit VEKTOR MEDICAL, INC.
37 00860007954108 VMDISP1 vMap Disposables VEKTOR MEDICAL, INC.
38 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
39 00857553006139 D300 D300 Cardea SOLO PC Software - ECG analysis software (D300) Cardea SOLO CARDIAC INSIGHT, INC.
40 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.
41 00857042007999 900000 900000 AcQMap System AcQMap ACUTUS MEDICAL, INC.
42 00857042007920 900100 900100 AcQMap System Console 2.0 AcQMap ACUTUS MEDICAL, INC.
43 00857042007876 800727 800727 AcQMap to DiamondTemp Generator Adapter DiamondTemp Generator Adapter ACUTUS MEDICAL, INC.
44 00857042007562 800605 800605 AcQMap Patient Electrode Kit AcQMap ACUTUS MEDICAL, INC.
45 00857042007425 800604 800604 AcQMap Auxiliary Interface Box, Console 2.0 AcQMap ACUTUS MEDICAL, INC.
46 00857042007388 800531 800531 Cable, AcQMap Surface ECG Output (AHA) Packaged AcQMap ACUTUS MEDICAL, INC.
47 00857042007364 800405 800405 POAG Cable MC-POAG-EC6/2 AcQMap ACUTUS MEDICAL, INC.
48 00857042007357 800255 800255 Workstation Cable AcQMap ACUTUS MEDICAL, INC.
49 00857042007333 800601 800601 Power Cord, Console 2.0 AcQMap ACUTUS MEDICAL, INC.
50 00857042007326 800505 800505 AcQMap Ablation Reference Cable AcQMap ACUTUS MEDICAL, INC.