System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, speci
System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging
System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona
System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty
syngo.via VB20A "Stock Keeping Unit C" - packaging label: This unit contains the
syngo.via VB20A "Stock Keeping Unit C" - packaging label: This unit contains the following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional -GTIN 04056869026305;(3) syngo.CT Coronary Analysis - GTIN 04056869026329;(4)syngo.CT Cardiac Function -GTIN 04056869026336;(5)syngo.CT CaScoring -GTIN 04056869026343;(6) syngo.CT Vascular Analysis -GTIN04056869026350;(7)syngo.CT Colonography -GTIN 04056869026367;(8)syngo.CT Pulmo3D -GTIN 04056869026374;(9)syngo.CT Neuro D
syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover: This uni
syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover: This unit contains the following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional -GTIN 04056869026305;(3) syngo.CT Coronary Analysis - GTIN 04056869026329;(4)syngo.CT Cardiac Function -GTIN 04056869026336;(5)syngo.CT CaScoring -GTIN 04056869026343;(6) syngo.CT Vascular Analysis -GTIN04056869026350;(7)syngo.CT Colonography -GTIN 04056869026367;(8)syngo.CT Pulmo3D -GTIN 04056869026374;(9)sy
contains Medical Device Mat.: 10835689 (GTIN: 04056869044699)
LNH,LNI,MOS
System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp
System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty
Contains Medical Device Mat. 10835446 (GTIN:04056869015460)
LNI,LNH,MOS
System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona
System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty
System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,S
System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic
Contains Medical Device Mat. 10496545 (GTIN:04056869014937)
LNI,LNH,MOS
System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona
System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty
Contains Medical Device Mat. 10496543 (GTIN:04056869014913)
LNI,MOS,LNH
System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, speci
System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging
Contains Medical Device Mat.10185552 (GTIN:04056869014784)
LNH,MOS,LNI
System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,S
System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic
Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectrosc
Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic,Tomographic imager combining emission computed tomography with nuclear magnetic resonance,System, nuclear magnetic resonance imaging
System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp
System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic,Tomographic imager combining emission computed tomography with nuclear magnetic resonance,Coil, magnetic resonance, specialty
Contains Medical Device Mat. 7579472 (GTIN:04056869014265)
LNI,MOS,LNH
System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, speci
System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging
EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a co
EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a co
EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a
EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
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.
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.
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.
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
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
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.
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.
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.
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.
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.
"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."
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.
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.
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.
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.
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.
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
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
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
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
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
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
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
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.
StealthView Software & Smart Cable - ECG analysis software (D300) and data trans
StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300).