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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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Invivo - 00884838091818

UroNav Version 3
Philips DS North America LLC
459801572611
In Commercial Distribution

  • 00884838091818 ()


  • Ultrasound imaging system application software

Invivo - 00884838089648

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

SmartPerfusion - 00884838088566

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

Dynamic Coronary Roadmap - 00884838086777

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

Patient Information Center iX - 00884838086715

Patient Information Center iX
Philips Medical Systems Hsg
Patient Information Center iX
Not in Commercial Distribution

  • 00884838086715 ()
866389

  • Centralized patient monitor

Invivo - 00884838086630

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

SmartCT - 00884838085732

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

Invivo - 00884838085510

DynaLync Prostate
Philips DS North America LLC
784016
Not in Commercial Distribution

  • 00884838085510 ()


  • MRI system application software

3D-CA - 00884838084773

Software medical device, used with a Philips Interventional X-Ray System. Creates a 3D model of the coronary vessel tree from a pair of 2D images from a rotational angiographic run.
Philips Medical Systems Nederland B.V.
3D-CA - 3
In Commercial Distribution

  • 00884838084773 ()
001109

  • Angiographic x-ray system application software

3D-RA - 00884838084766

Software medical device, used with a Philips Interventional X-Ray System. Creates 3D views of vessels and bones from sets of 2D images from rotational angiographic runs.
Philips Medical Systems Nederland B.V.
3D-RA - 6
In Commercial Distribution

  • 00884838084766 ()
001102

  • Angiographic x-ray system application software
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