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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
DESYNCRA TINNITUS LIMITED
Size L
In Commercial Distribution

  • EDSYTI1003EU01 ()
TI10.03EU_01

  • Tinnitus masking application software
No Description
DESYNCRA TINNITUS LIMITED
Size M
In Commercial Distribution

  • EDSYTI1002EU01 ()
TI10.02EU_01

  • Tinnitus masking application software
No Description
DESYNCRA TINNITUS LIMITED
Size S
In Commercial Distribution

  • EDSYTI1001EU01 ()
TI10.01EU_01

  • Tinnitus masking application software
OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest.
REBRAIN
v2.0.1
In Commercial Distribution

  • 03770021895035 ()


  • Stereotactic system application software
OptimMRI is a software application for processing medical images of the brain that enables 3D visualization and analysis of anatomical structures. Specifically, the software can be used to read DICOM compatible pre-operative MR images acquired by commercially available imaging devices. These images can be processed to generate 3D markers in specific regions of the anatomy to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan neurosurgical functional procedures. OptimMRI is used as an aid to localize regions of the brain such as Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM).
REBRAIN
v1.2.0
In Commercial Distribution

  • 03770021895011 ()


  • Stereotactic system application software
inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D models of the patient heart from medical images acquired by CT and/or MR devices. inHEART MODELS Shaper 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 users are solely responsible for making all final patient management decisions.
INHEART
v1.8.0
In Commercial Distribution

  • 03770019599082 ()


  • Image segmentation application software
inHEART MODELS AI is a medical image processing software for automatic 3D modelling, used to pre-process medical images (acquired only by CT devices). inHEART Models AI results are intended to be reviewed and, if needed, edited by inHEART trained staff with inHEART Models Shaper. inHEART MODELS AI 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
v1.1.0
In Commercial Distribution

  • 03770019599075 ()


  • Image segmentation application software
inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D models of the patient heart from medical images acquired by CT and/or MR devices. inHEART MODELS Shaper 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 users are solely responsible for making all final patient management decisions.
INHEART
v1.4.0
Not in Commercial Distribution

  • 03770019599037 ()


  • Image segmentation application software
inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac images. It provides simple image review software functionality for basic medical image processing and manipulation, such as grayscale window and level, zoom and pan, image reformat, thresholding or user delineated geometric measurements (distance and volume). It is intended to be used by inHEART trained staffs. inHEART Models Shaper 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
v1.2.0
Not in Commercial Distribution

  • 03770019599013 ()


  • Image segmentation application software
A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy. Hardware reference: Lenovo Thinkcentre M70a
KOELIS
KURO-4000
In Commercial Distribution

  • 03665134000929 ()


  • Image segmentation application software
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