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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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Kinesis Balance is a smartphone application for assessment of balance and falls risk in older adults. The product is software based and uses simple clinical questionnaires and the sensors embedded in a smartphone to measure balance and assess risk of falls. The application is intended to be used by older adults and their carers in the home.
KINESIS
2.0.1
In Commercial Distribution

  • 05391542950027 ()


  • Posturography system application software
No Description
Balance Tracking Systems Incorporated
Version 7
In Commercial Distribution

  • 00860010129111 ()


  • Posturography system application software
FeetMe Evaluation mobileAndroid application version 3.Y.Z.
FEETME
3
In Commercial Distribution

  • 03760349820062 ()


  • Posturography system application software
This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.
FUJIFILM CORPORATION
EW10-EC02
In Commercial Distribution

  • 04547410541199 ()


  • Endoscopic video image interpretive software
The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT 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 and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 3
In Commercial Distribution

  • 00853341006053 ()


  • Vascular modelling software
The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT 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 and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 2
In Commercial Distribution

  • 00853341006039 ()


  • Vascular modelling software
HeartFlow FFRct is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT 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. FFRct is independent of imaging equipment, imaging protocols and equipment vendors; the clinical validation report includes identification of vendors and equipment used in the clinical validation of the product. This data is summarized in the product labeling, and can be found in the Clinical User Instructions for Use. HeartFlow FFRct analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
v2.18
In Commercial Distribution

  • 00853341006022 ()


  • 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

  • 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
ULTROMICS LIMITED
Core 2.0
In Commercial Distribution

  • 05060634690027 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
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