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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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Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.4.0
In Commercial Distribution

  • 00628011382146 ()


  • Radiation therapy software
Version >=3.0
STRYKER CORPORATION
521205090001
In Commercial Distribution

  • 07613327624328 ()
521205090001

  • Alarm application software
No Description
Orthosoft Inc
803.302
In Commercial Distribution

  • 00887868557606 ()
803.302

  • CAD/CAM software
No Description
Orthosoft Inc
803.308
In Commercial Distribution

  • 00887868557590 ()
803.308

  • CAD/CAM software
LRF Web Application
Stryker GmbH
983031
In Commercial Distribution

  • 07613327297751 ()
983031

  • CAD/CAM software
EsayVIz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologist, Cardiologists, Clinicians and referring Physicians.
Canon Medical Informatics A/S
7.2
Not in Commercial Distribution

  • 62810500000024 ()


  • Radiological PACS software
IMAGE SUITE / V4 SW MEDICAL APP
CARESTREAM HEALTH, INC.
CARESTREAM Image Suite
In Commercial Distribution

  • 60889971055989 ()
1055987

  • Radiological PACS software
VUE MOTION UNLIMITED SW < 50K EX/YR
CARESTREAM HEALTH, INC.
Vue Motion
In Commercial Distribution

  • 60889971048875 ()
1017979

  • Radiological PACS software
UNLIMITED READING LIC < 25K EX/YR
CARESTREAM HEALTH, INC.
Vue PACS
In Commercial Distribution

  • 60889971047809 ()
1149418

  • Radiological PACS software
PACS WFM SW < 25K EXAMS/YR
CARESTREAM HEALTH, INC.
Vue PACS
In Commercial Distribution

  • 60889971041692 ()
1201284

  • Radiological PACS software
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