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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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FFRct - 00853341006015

HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease. HeartFlow FFRct is independent of imaging equipment, imaging protocols and equipment vendors. HeartFlow analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and workstations.
Heartflow, Inc.
v2.1
In Commercial Distribution

  • 00853341006015 ()


  • Vascular modelling software

FFRct - 00853341006008

HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease. HeartFlow FFRct is independent of imaging equipment, imaging protocols and equipment vendors. HeartFlow analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and workstations.
Heartflow, Inc.
v2.1
In Commercial Distribution

  • 00853341006008 ()


  • Vascular modelling software

Cerner CareAware Event Management - 00853023006135

No Description
Cerner Corporation
CareAwareEventManagement6
In Commercial Distribution

  • 00853023006135 ()


  • Alarm application software

Cerner CareAware Event Management - 00853023006111

No Description
Cerner Corporation
CareAwareEventManagement5
In Commercial Distribution

  • 00853023006111 ()


  • Alarm application software

Datrix - 00851074007361

ECG Recorder
DATRIX LLC
VX3+ Series T
In Commercial Distribution

  • 00851074007361 ()
VX3+ Series T

  • Electrocardiographic ambulatory recorder

Datrix - 00851074007316

ECG Recorder
DATRIX LLC
VX3+ Series L
In Commercial Distribution

  • 00851074007316 ()


  • Electrocardiographic ambulatory recorder

VX3+ - 00851074007156

Holter Recorder
DATRIX LLC
VX3+ Series H
In Commercial Distribution

  • 00851074007156 ()


  • Electrocardiographic ambulatory recorder

VX3+ - 00851074007095

Holter Recorder
DATRIX LLC
VX3+ Series Hatco
In Commercial Distribution

  • 00851074007095 ()


  • Electrocardiographic ambulatory recorder

VX3+ - 00851074007064

Holter Recorder
DATRIX LLC
VX3+ Series CDM
In Commercial Distribution

  • 00851074007064 ()


  • Electrocardiographic ambulatory recorder

VX3+ - 00851074007057

Holter Recorder
DATRIX LLC
VX3+ Series C
In Commercial Distribution

  • 00851074007057 ()


  • Electrocardiographic ambulatory recorder
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