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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 Upgrade Kitv.3.0.1.1
ST. JUDE MEDICAL, INC.
H21921
In Commercial Distribution

  • 05414734219211 ()
H21921

  • Cardiac mapping system application software
No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214841 ()
75-06066-001

  • Cardiac mapping system application software
No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214636 ()
75-05772-001

  • Cardiac mapping system application software
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
WBR Imaging X + X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177121 ()


  • SPECT system application software
WBR Imaging X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177114 ()


  • SPECT system application software
WBR Imaging X + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177107 ()


  • SPECT system application software
WBR Imaging X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177053 ()


  • SPECT system application software
WBR Imaging X + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177046 ()


  • SPECT system application software
WBR Imaging Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177039 ()


  • SPECT system application software
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