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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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No Description
GE HEALTHCARE
CPACS 7.0
In Commercial Distribution

  • 00840682145572 ()


  • Radiological PACS software
No Description
GE HEALTHCARE
CPACS 7.0
In Commercial Distribution

  • 00840682145558 ()


  • Radiological PACS software
No Description
MILVUE
V1.1.x
In Commercial Distribution

  • 03770024774047 ()


  • Radiological PACS software
No Description
GLEAMER
1.0.X
In Commercial Distribution

  • 03770020839092 ()


  • Radiological PACS software
No Description
GLEAMER
1.1.X
In Commercial Distribution

  • 03770020839085 ()


  • Radiological PACS software
No Description
GLEAMER
1.X-US
In Commercial Distribution

  • 03770020839009 ()


  • Radiological PACS software
The current version of the medical device includes the Annotate and the SmartFuse module that intends to help the practitioner to delineate organs at risks manually, semi-automatically and automatically. The Smartfuse module is also providing the possibility to do a fusion of images from different modalities. This version also contains an administration module, that allows the user to manage data and rights.
THERAPANACEA
v.1.10.0
In Commercial Distribution

  • 03770019940006 ()


  • Radiation therapy software
inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART Models Shaper. inHEART Models Explorer is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
INHEART
v3.0.0
In Commercial Distribution

  • 03770019599112 ()
NA

  • Radiological PACS software
inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper. inHEART MODELS Explorer is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
INHEART
v2.8.0
Not in Commercial Distribution

  • 03770019599099 ()


  • Radiological PACS software
inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper. inHEART Models Explorer is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
INHEART
v2.5.0
Not in Commercial Distribution

  • 03770019599020 ()


  • Radiological PACS software
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