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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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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
inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models segmented from medical images including cardiac images (CT and/or MR). It is intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians), as well as by inHEART trained staffs. inHEART Models Explorer is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians). Clinicians are solely responsible for making all final patient management decisions.
INHEART
v2.2.1
Not in Commercial Distribution

  • 03770019599006 ()


  • Radiological PACS software
QuantX is a software program that is used to view and analyze patient breast images.
QLARITY IMAGING, LLC
Breast MRI SE
Not in Commercial Distribution

  • B80731 ()
3

  • Radiological PACS software
The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
QLARITY IMAGING, LLC
Breast MRI Biopsy Guidance Plugin
In Commercial Distribution

  • B80721 ()
2

  • Radiological PACS software
QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.
QLARITY IMAGING, LLC
Breast MRI
In Commercial Distribution

  • B80711 ()
1

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

  • 03770024774047 ()


  • Radiological PACS software
LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports.
MEDIAN TECHNOLOGIES
6.0
In Commercial Distribution

  • 03760263520024 ()


  • Radiological PACS software
LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to: - visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user; - compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation) - generate automatic reports.
MEDIAN TECHNOLOGIES
6.0
In Commercial Distribution

  • 03760263520017 ()


  • Radiological PACS software
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