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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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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
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
No Description
Cerner Corporation
CareAwareEventManagement6
In Commercial Distribution

  • 00853023006135 ()


  • Alarm application software
No Description
Cerner Corporation
CareAwareEventManagement5
In Commercial Distribution

  • 00853023006111 ()


  • Alarm application software
SEER 1000 PC APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 PC Application
In Commercial Distribution

  • 00840682116886 ()


  • Electrocardiographic ambulatory recorder
SEER 1000 IOS APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 IOS Application
In Commercial Distribution

  • 00840682116879 ()


  • Electrocardiographic ambulatory recorder
SenoIris 1 SP2.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682104395 ()


  • Diagnostic x-ray digital imaging system workstation
Endoflip system 1.0 refurbished
Covidien LP
RFG-EF100
In Commercial Distribution

  • 10884521808096 ()


  • Manometric gastrointestinal motility analysis system
Endolumenal Functional Lumen Imaging Probe
Covidien LP
EF-325N
In Commercial Distribution

  • 20884521809427 ()
  • 10884521809420 ()
  • 30884521809424 ()


  • Manometric gastrointestinal motility analysis system
Endolumenal Functional Lumen Imaging Probe
Covidien LP
EF-322N
In Commercial Distribution

  • 20884521809410 ()
  • 10884521809413 ()
  • 30884521809417 ()


  • Manometric gastrointestinal motility analysis system
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