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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 Size Device Size Type Device Class Implantable

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The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.
Philips Medical Systems Nederland B.V.
733015
Not in Commercial Distribution

  • 00884838095229 ()


  • Cardiac mapping system application software
DynaCAD is a MR image analysis software medical device that consists of MR Analysis Server, Viewer application, and Interventional Planning application.
Philips DS North America LLC
5
In Commercial Distribution

  • 00884838094857 ()
4598-016-98182, 3000-103-14352, 300011916421

  • MRI system application software
MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain)
Philips Oy
MRCAT Brain / RTgo 4.0
In Commercial Distribution

  • 00884838094093 ()
781439

  • MRI system application software
MR-RT RTgo software USB stick
Philips Oy
459801266633
In Commercial Distribution

  • 00884838092112 ()


  • MRI system application software
UroNav Version 3
Philips DS North America LLC
459801572611
In Commercial Distribution

  • 00884838091818 ()


  • Ultrasound imaging system application software
UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician.
Philips DS North America LLC
784026
In Commercial Distribution

  • 00884838089648 ()


  • Ultrasound imaging system application software
Software medical device used with a Philips Interventional X-Ray System. Provides color coded representation of digital subtraction angiography to assist diagnosis of perfusion alterations of tissues.
Philips Medical Systems Nederland B.V.
SmartPerfusion - 1
In Commercial Distribution

  • 00884838088566 ()
001119

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.
Philips Medical Systems Nederland B.V.
Dynamic Coronary Roadmap - 2
In Commercial Distribution

  • 00884838086777 ()
001016

  • Angiographic x-ray system application software
DynaCAD is a MR image analysis software medical device that consists of MR Analysis Server, Viewer application, and Interventional Planning application.
Philips DS North America LLC
4.0
In Commercial Distribution

  • 00884838086630 ()


  • MRI system application software
Software medical device, used with a Philips Interventional X-Ray System. Assists physicians by providing 3D views of the anatomy combined with planning and life guidance functionality.
Philips Medical Systems Nederland B.V.
SmartCT - 1
In Commercial Distribution

  • 00884838085732 ()
001018

  • Angiographic x-ray system application software
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