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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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SICAT Air - D776AIRV200

No Description
SiCAT GmbH & Co. KG
2.0
Not in Commercial Distribution

  • D776AIRV200 ()


  • Radiological PACS software

MIStar - B409MISTAR320

MIStar is a software package, which runs on a Windows-based PC platform. It allows manipulation, visualization and processing of medical images acquired with various clinical scanners and stored in DICOM and /or other proprietary formats. MIStar allows transfer of DICOM 3.0 images over a medical imaging network. MIStar also provides post-processing of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer. It allows visual inspection of time intensity curves and calculation of parametric parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also allows calculation of various perfusion related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability) from dynamic CT data. The results are displayed in a user-friendly graphic format as parametric images that provide supplementary information for diagnosis purposes.
APOLLO MEDICAL IMAGING TECHNOLOGY PTY. LTD.
3.2
In Commercial Distribution

  • B409MISTAR320 ()
MISTAR32

  • Radiological PACS software

InsightRT Software Suite Server - B244ISS100S0

No Description
SIRIS MEDICAL, INC.
ISS100S
Not in Commercial Distribution

  • B244ISS100S0 ()
ISS100S

  • Radiation therapy software

InsightRT CDS - B244IRT1000

No Description
SIRIS MEDICAL, INC.
IRT100
In Commercial Distribution

  • B244IRT1000 ()
IRT100

  • Radiation therapy software

System 2100 - B229S210011

No Description
MATH RESOLUTIONS, LLC
1
In Commercial Distribution

  • B229S210011 ()


  • Radiation therapy software

RtDosePlan - B229RTDP21

No Description
MATH RESOLUTIONS, LLC
2
In Commercial Distribution

  • B229RTDP21 ()


  • Radiation therapy software

MarkRT - B229MRT21

No Description
MATH RESOLUTIONS, LLC
2
In Commercial Distribution

  • B229MRT21 ()


  • Radiation therapy software

MillComp - B229MC11

No Description
MATH RESOLUTIONS, LLC
1
In Commercial Distribution

  • B229MC11 ()


  • Radiation therapy software

Dosimetry Check - B229DC051

No Description
MATH RESOLUTIONS, LLC
5
In Commercial Distribution

  • B229DC051 ()


  • Radiation therapy software

Dosimetry Check - B229DC041

No Description
MATH RESOLUTIONS, LLC
4
In Commercial Distribution

  • B229DC041 ()


  • Radiation therapy software

InteleShare - B228INTELESHARE0

No Description
Les Systèmes Médicaux Intelerad Incorporée
3
In Commercial Distribution

  • B228INTELESHARE0 ()


  • Radiological PACS software

INTELEPACS - B228INTELEPACS0

No Description
Les Systèmes Médicaux Intelerad Incorporée
INTELEPACS
In Commercial Distribution

  • B228INTELEPACS0 ()


  • Radiological PACS software

InteleHeart - B228INTELEHEART0

PACS Device
Les Systèmes Médicaux Intelerad Incorporée
9
In Commercial Distribution

  • B228INTELEHEART0 ()


  • Radiological PACS software

Odyssey - B211ODY520106

Odyssey is a Radiation Therapy Treatment Planning System, Windows based software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be exported in DICOM formats to administer treatments after review and approval by the intended user.
PERMEDICS INC
5.2.01
In Commercial Distribution

  • B211ODY520106 ()


  • Radiation therapy software

Odyssey - B211ODY520005

Odyssey is a Radiation Therapy Treatment Planning System, Windows based software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be exported in DICOM formats to administer treatments after review and approval by the intended user.
PERMEDICS INC
5.2.00
In Commercial Distribution

  • B211ODY520005 ()


  • Radiation therapy software

V3D-Explorer - B209XP2X00

V3D-Explorer is a software application used with advanced PC hardware for the display and 3D visualization of DICOM 3.0 compliant medical images derived from CT, MRI, PET and SPECT scans. The linear, angular and volume measurement features provided in the software for the evaluation and quantification of organ, hard and soft tissues as well as internal organ structures for lesion, mass and other anomalies. It also supports interactive segmentation of any organ.
VIATRONIX INCORPORATED
2.0
In Commercial Distribution

  • B209XP2X00 ()


  • Radiological PACS software

V3D-Colon - B209VC4X1X2X330

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
4.1.2.33
In Commercial Distribution

  • B209VC4X1X2X330 ()


  • Radiological PACS software

V3D-Colon - B209VC4X1X2X320

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 - B209VC4X1X2X110

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
4.1.2.11
In Commercial Distribution

  • B209VC4X1X2X110 ()


  • Radiological PACS software

V3D-Colon - B209VC4X1X1X150

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
4.1.1.15
In Commercial Distribution

  • B209VC4X1X1X150 ()


  • Radiological PACS software

V3D-Colon - B209VC4X0X3X40

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
4.0.3.4
In Commercial Distribution

  • B209VC4X0X3X40 ()


  • Radiological PACS software

V3D-Colon - B209VC4X0X3X13F0

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 - B209VC4X0X0X44F0

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 - B209VC4X0X0X360

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
4.0.0.36
In Commercial Distribution

  • B209VC4X0X0X360 ()


  • Radiological PACS software

V3D-Colon - B209VC3X3X3X10

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-Vascular - B209VA2X00

V3D-Vascular is a software application used with advanced PC hardware for evaluating scanned images of selected vessels. It is designed to aid the physician in analyzing the vascular system based on DICOM 3.0 compliant images from CT or MR scan.
VIATRONIX INCORPORATED
2.0
In Commercial Distribution

  • B209VA2X00 ()


  • Radiological PACS software

V3D-Calcium Scoring - B209CAS2X10

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-Calcium Scoring - B209CAS2X00

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
2.0
In Commercial Distribution

  • B209CAS2X00 ()


  • Radiological PACS software

V3D-Cardiac - B209CAR1X10

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

HealthMyne - B198HMV11R70

No Description
HEALTHMYNE, INC.
11.7
In Commercial Distribution

  • B198HMV11R70 ()
HMV11R7

  • Radiological PACS software
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