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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 hosting platform, used with a Philips Interventional X-Ray System. Provides common functionalities (e.g. import / export, data handling) for other software medical devices.
Philips Medical Systems Nederland B.V.
Interventional Workspot - 1
In Commercial Distribution

  • 00884838059191 ()
001000

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Provides navigation support for cardiovascular devices for heart rhythm disorders.
Philips Medical Systems Nederland B.V.
EP navigator - 5
In Commercial Distribution

  • 00884838059184 ()
000071

  • 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 - 4
In Commercial Distribution

  • 00884838106437 ()


  • Angiographic x-ray system application software
StentBoost Mobile is a software product intended to provide a high resolution visualization of stents in vessels. It supports the physician in placing and deploying stents.
Philips India Limited
StentBoost Mobile
In Commercial Distribution

  • 00884838103450 ()
718160

  • 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 - 3
In Commercial Distribution

  • 00884838101883 ()
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
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
Software for cardiac image analysis.
Medviso AB
2
In Commercial Distribution

  • 07350010100027 ()


  • MRI system application software
SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. SyMRI can also generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, output from SyMRI can provide information useful in determining diagnosis. SyMRI 2D is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR). T1W and T2W images from SyMRI 3D may replace conventional MR images in a clinical setting when interpreting together with a conventional 3D T2W FLAIR image.
SyntheticMR AB (publ)
15
In Commercial Distribution

  • 07340024700078 ()


  • MRI system application software
SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. When interpreted by a trained physician, the parametric maps, tissue maps, and volumetrics from SyMRI can provide information useful in determining diagnosis. SyMRI is indicated for head imaging. SyMRI can also generate multiple contrast weighted images from the parametric maps generated by post-processing data from M2D-MDME sequence. SyMRI enables post-acquisition image contrasts adjustments from acquisition using M2D-MDME sequence. When M2D-MDME acquisition data is used as input to SyMRI the synthetic contrast weighted images can also provide information useful in determining diagnosis. SyMRI is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
14
In Commercial Distribution

  • 07340024700061 ()


  • MRI system application software
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