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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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MediGuide™ - 05415067004314

Magnetic Transmitter Assembly
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067004314 ()
H700431

  • Cardiac mapping system

MediGuide™ - 05415067004307

No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067004307 ()
H700430

  • Cardiac mapping system

EnSite™ - 05415067003867

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H700386
In Commercial Distribution

  • 05415067003867 ()
H700386

  • Cardiac mapping system

EnSite™ Velocity™ - 05415067001061

DWS Kit
ST. JUDE MEDICAL, INC.
100052576
In Commercial Distribution

  • 05415067001061 ()
100052576

  • Cardiac mapping system

EnSite™ - 05415067001054

Display Workstation (DWS)
ST. JUDE MEDICAL, INC.
100027826
In Commercial Distribution

  • 05415067001054 ()
100027826

  • Cardiac mapping system

EnSite™ - 05415067000910

Display Workstation
ST. JUDE MEDICAL, INC.
EE3000
In Commercial Distribution

  • 05415067000910 ()
EE3000

  • Cardiac mapping system

MediGuide™ - 05415067000712

PRS Patch
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 15415067000719 ()
  • 05415067000712 ()
H700071

  • Cardiac mapping system

EnSite™ Velocity™ - 05414734210713

Amplifier
ST. JUDE MEDICAL, INC.
100014514
In Commercial Distribution

  • 05414734210713 ()
100014514

  • Cardiac mapping system

CardioInsight™ - 00643169723603

MAPPING SYSTEM CIT200 CIT US
MEDTRONIC, INC.
CIT200
In Commercial Distribution

  • 00643169723603 ()


  • Cardiac mapping system

AI4CMR - 05600250059022

AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion Indications for use: AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution

  • 05600250059022 ()


  • MRI system application software
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