"The Vdrive® system is intended to stabilize, navigate and remotely control: • C
"The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). "
The Vdrive with V-Loop disposable is indicated to remotely control the advanceme
The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatibile loop catheters inserted across the septum into the left atrium using conventional procedures
The Stereotaxis Cardiodrive is intended for automatically advancing and retracti
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
The Odyssey Workstation is an optional display and user interface package design
The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
Vdrive with V-Sono is indicated for remotely controlling the advancement, retrac
Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium
The Odyssey Workstation is an optional display and user interface package design
The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
The Odyssey Workstation is an optional display and user interface package design
The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
The Vdrive with V-CAS Disposable is indicated for remotely controlling the advan
The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System
The Odyssey Workstation is an optional display and user interface package design
The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigat
The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS.
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe M
The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe M
The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe M
The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
"The Vdrive® system is intended to stabilize, navigate and remotely control: • C
"The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). "
Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Work
Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
"The Vdrive® system is intended to stabilize, navigate and remotely control: • C
"The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). "
The Stereotaxis Cardiodrive is intended for automatically advancing and retracti
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
The Stereotaxis Cardiodrive is intended for automatically advancing and retracti
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
The Stereotaxis Cardiodrive is intended for automatically advancing and retracti
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
The Stereotaxis Cardiodrive is intended for automatically advancing and retracti
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Work
Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
The Stereotaxis Cardiodrive is intended for automatically advancing and retracti
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
Genesis MNS is intended to navigate compatible magnetic devices through tissue t
Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right andleft heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desireddirection.
PJB,NDQ
Catheter Remote Control System,System, Catheter Or Guidewire, Steerable (Magnetic)
"Genesis MNS is intended to navigate compatible magnetic devices through tissue
"Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right andleft heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desireddirection. "
PJB,NDQ
Catheter Remote Control System,System, Catheter Or Guidewire, Steerable (Magnetic)
Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Work
Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bl
Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bluetooth 2.1 connectivity for telehealth applications. This is built on a PWR-09-02 device, which an also support other glucose meter families if appropriate cables are provided:"B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ,"A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite
This cable is used to connect the Polytel PWR-09-02 GMA2 unit to glucose meters
This cable is used to connect the Polytel PWR-09-02 GMA2 unit to glucose meters from LifeScan
Glucose meter accessory providing Bluetooth connectivity for existing glucose me
Glucose meter accessory providing Bluetooth connectivity for existing glucose meters. Depending on which cable is provisioned, this device supports different existing glucose meters."L" cable: LifeScan OneTouch Ultra, Ultra2, UltraMini, UltraEasy, Select, Basic"B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ, "A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
TRAQinform Reports is a 100% software medical device data system that provides u
TRAQinform Reports is a 100% software medical device data system that provides users with the means to select, render and modify layouts of static and interactive reports. TRAQinform Reports does not perform any image analysis or image processing of medical images. The device provides features to render available data components to formatted PDF, web pages, or text files.
The TRAQinform Preprocessor is a 100% software medical device data system that p
The TRAQinform Preprocessor is a 100% software medical device data system that provides users with the means to filter, perform quality checks, organize, and convert images from DICOM into other file formats including but not limited to Nearly Raw Raster Data (NRRD) format.
Real time patient data monitoring, secure clinical communications, monitor & ve
Real time patient data monitoring, secure clinical communications, monitor & vent waveforms, alarms and notifications anywhere, anytime for clinicians
Brand-independent integration with Ceiba eConnect APIs of medical devices (monit
Brand-independent integration with Ceiba eConnect APIs of medical devices (monitors, respirators, pumps, blood gas) and hospital systems
eClinics is a stand-alone software product used by professional care providers i
eClinics is a stand-alone software product used by professional care providers in ICU and other critical care settings for the presentation, collection, management and storage of patient information
The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that
The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
The OR Base Station subsystem is intended to send and receive data to and from t
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary OR Base Station / OR PC App / OR Registration
The CentrePoint Data Hub is a home-based communication gateway that securely tra
The CentrePoint Data Hub is a home-based communication gateway that securely transmits data captured by ActiGraph activity monitors.
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use.
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includingpatient demographics, images, videos, and HL7 messages. It also handles user accounts, security, clientconfiguration, and the flow of data between modalities and destination DICOM systems. PACSgear
Image Link Plus supports imaging workflows that do not follow the radiology work
Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR).
Health Harmony Mobile is a component of the Health Harmony Remote Patient Monito
Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The Enterprise version of Health Harmony Mobile is pre-loaded by the manufacturer on a personal mobile device that is provided to the patient in a Health Harmony Kit.
Health Harmony Mobile is a component of the Health Harmony Remote Patient Monito
Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The BYOD version of Health Harmony Mobile is available for download by the patient onto their own personal mobile device.
After the surgery is completed, the OR Barcode Scanner can be used to scan the b
After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components.