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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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EnSite™ - 05415067046666

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-201
In Commercial Distribution

  • 05415067046666 ()
ENSITE-SYSTEM-201

  • Cardiac mapping system

EnSite™ - 05415067032188

Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-01
In Commercial Distribution

  • 05415067032188 ()
ENSITE-R-DWS-01

  • Cardiac mapping system

EnSite™ - 05415067032171

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-01
In Commercial Distribution

  • 05415067032171 ()
ENSITE-DWS-01

  • Cardiac mapping system

EnSite™ - 05415067032164

Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-R-AMP-01
In Commercial Distribution

  • 05415067032164 ()
ENSITE-R-AMP-01

  • Cardiac mapping system

EnSite™ - 05415067032157

Amplifier
ST. JUDE MEDICAL, INC.
ENSITE-AMP-01
In Commercial Distribution

  • 05415067032157 ()
ENSITE-AMP-01

  • Cardiac mapping system

EnSite™ Velocity™ - 05414734210713

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

  • 05414734210713 ()
100014514

  • Cardiac mapping system

EnSite™ Velocity™ - 05414734031035

Workstation
ST. JUDE MEDICAL, INC.
100026148
In Commercial Distribution

  • 05414734031035 ()
100026148

  • 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

ClinicalAccess Pro Connect - 00850033167221

The ClinicalAccess®, Pro Connect is a feature rich medical station designed to enhance efficiency and patient care in healthcare settings. The Pro Connect comes equipped with dual 22" monitors, ClearCam® PTZ with 12x optical zoom, Jabra conferencing microphone and speaker, integrated small form factor PC, and lockable device storage.
Globalmed Holdings, LLC
1.0
In Commercial Distribution

  • 00850033167221 ()
1CAP001-C01 / 1CAP001-C02

  • Medical image management system

First Exam Station - 00850033167139

Videoconferencing cart
Globalmed Holdings, LLC
First Exam Station
In Commercial Distribution

  • 00850033167139 ()


  • Medical image management system
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