Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Class Implantable

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No Description
Vektor Medical, Inc.
VMCU1
In Commercial Distribution

  • 00860007954177 ()


  • Cardiac mapping system computer
No Description
Vektor Medical, Inc.
VMDISP1
In Commercial Distribution

  • 00860007954108 ()


  • Cardiac mapping system computer
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.
APN HEALTH
Navik 3D v2.0
In Commercial Distribution

  • 00869781000308 ()
200-00668

  • Cardiac mapping system computer
The Ablamap® System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and workstation that contains proprietary mapping software. Signals are transmitted from a 64-electrode mapping “basket” catheter, through the amplifier, to the workstation, processed by the mapping software, and the results are displayed on the monitor.
Ablacon Inc.
AB-0007
In Commercial Distribution

  • 00860457001568 ()


  • Cardiac mapping system computer
No Description
CHANGE HEALTHCARE ISRAEL LTD
1.3
Not in Commercial Distribution

  • 17540262120028 ()


  • Cardiac mapping system computer
No Description
CHANGE HEALTHCARE ISRAEL LTD
1.2.4
Not in Commercial Distribution

  • 17540262120011 ()


  • Cardiac mapping system computer
No Description
Change Healthcare Canada Company
15.1.1
In Commercial Distribution

  • 17540262110135 ()


  • Cardiac mapping system computer
No Description
Change Healthcare Canada Company
15.1
In Commercial Distribution

  • 17540262110128 ()


  • Cardiac mapping system computer
No Description
Change Healthcare Canada Company
15.0.1
In Commercial Distribution

  • 17540262110104 ()


  • Cardiac mapping system computer
No Description
Change Healthcare Canada Company
15.0
In Commercial Distribution

  • 17540262110098 ()


  • Cardiac mapping system computer
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