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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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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 - 1
In Commercial Distribution

  • 00884838080805 ()
001016

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Assists the user with treatment of structural heart diseases using minimal invasive interventional techniques.
Philips Medical Systems Nederland B.V.
HeartNavigator - 3
In Commercial Distribution

  • 00884838080744 ()
001001

  • Angiographic x-ray system application software
Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.
Philips Medical Systems Nederland B.V.
EchoNavigator - 3
In Commercial Distribution

  • 00884838080737 ()
001011

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Provides quantitative information about coronary arteries, peripheral arteries, and ventricles.
Philips Medical Systems Nederland B.V.
2D Quantitative Analysis - 1
In Commercial Distribution

  • 00884838075863 ()
001014

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Creates a CT based 3D model of the coronary vessel tree. Provides a composite image of 2D X-ray exposure image and 3D model.
Philips Medical Systems Nederland B.V.
CT Trueview - 2
In Commercial Distribution

  • 00884838064782 ()
001010

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Intended to assist in the treatment of endovascular diseases during an endovascular intervention procedure.
Philips Medical Systems Nederland B.V.
VesselNavigator - 1
In Commercial Distribution

  • 00884838064775 ()
001013

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Intended to assist with saccular cerebral aneurysm embolization, by visualizing and quantifying blood flow changes.
Philips Medical Systems Nederland B.V.
AneurysmFlow - 1
In Commercial Distribution

  • 00884838064768 ()
001015

  • Angiographic x-ray system application software
LAPAROSCOPY PACK II
Cardinal Health 200, LLC
SBA23LPHM2
In Commercial Distribution

  • 50195594198587 ()
  • 10195594198589 ()
SBA23LPHM2

  • Decontamination floor mat, single-use
Software medical device, used with a Philips Interventional X-Ray System. Reconstructs 3D volumes from rotational fluoroscopic acquisitions and provides CT-like images to assist the physician.
Philips Medical Systems Nederland B.V.
XperCT Dual - 3
In Commercial Distribution

  • 00884838059306 ()
001105

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Extension of XperCT. Assists physicians with embolization of hypervascular tumors in the liver using interventional X-ray.
Philips Medical Systems Nederland B.V.
EmboGuide - 1
In Commercial Distribution

  • 00884838059290 ()
001012

  • Angiographic x-ray system application software
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