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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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V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon.
VIATRONIX INCORPORATED
4.1.2.32
In Commercial Distribution

  • B209VC4X1X2X320 ()


  • Radiological PACS software
V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon.
VIATRONIX INCORPORATED
4.0.3.13
In Commercial Distribution

  • B209VC4X0X3X13F0 ()


  • Radiological PACS software
V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon.
VIATRONIX INCORPORATED
4.0.0.44
In Commercial Distribution

  • B209VC4X0X0X44F0 ()


  • Radiological PACS software
V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon.
VIATRONIX INCORPORATED
3.3.3.1
In Commercial Distribution

  • B209VC3X3X3X10 ()


  • Radiological PACS software
V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent.
VIATRONIX INCORPORATED
2.1
In Commercial Distribution

  • B209CAS2X10 ()


  • Radiological PACS software
V3D-Cardiac is a software application used with advanced PC hardware for evaluating DICOM 3.0 compliant CT images of the human heart. It is designed to aid the physician in analyzing the heart anatomy and detecting anomalies based on contrast enhanced CT images. It provides both coronary artery tracking and left ventricle volume analyzing tools for single or multi-phase CT scan.
VIATRONIX INCORPORATED
1.1
In Commercial Distribution

  • B209CAR1X10 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
11.7
In Commercial Distribution

  • B198HMV11R70 ()
HMV11R7

  • Radiological PACS software
No Description
HEALTHMYNE, INC.
11.5
In Commercial Distribution

  • B198HMV11R50 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
11.4
In Commercial Distribution

  • B198HMV11R40 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
11.3
In Commercial Distribution

  • B198HMV11R30 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
11.1
In Commercial Distribution

  • B198HMV11R1PK0 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
12.2
In Commercial Distribution

  • B198HM01220 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
12.1
In Commercial Distribution

  • B198HM01210 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
12.0
In Commercial Distribution

  • B198HM0120 ()
HMV12

  • Radiological PACS software
No Description
HEALTHMYNE, INC.
11.6
In Commercial Distribution

  • B198HM01160 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
11.0
In Commercial Distribution

  • B198HM0110 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
10.2
In Commercial Distribution

  • B198HM0102 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
10.1
In Commercial Distribution

  • B198HM0101 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
10.0
In Commercial Distribution

  • B198HM0100 ()


  • Radiological PACS software
No Description
HEALTHMYNE, INC.
9.0
In Commercial Distribution

  • B198HM0090 ()


  • Radiological PACS software
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