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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
Icad, Inc.
D4D0223
In Commercial Distribution

  • 00850008977220 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
D4D0222
In Commercial Distribution

  • 00850008977213 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
10.1
In Commercial Distribution

  • 00850008977206 ()
DSC018-03, DSC018-06, DSC018-03, D4D0180

  • Radiology DICOM image processing application software
No Description
Icad, Inc.
D4D0211
In Commercial Distribution

  • 00850008977169 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
D4D0212
In Commercial Distribution

  • 00850008977152 ()


  • Radiology DICOM image processing application software
ShowCase Image Center is an image management application that can automatically receive images from most DICOM capable imaging devices.
TRILLIUM TECHNOLOGY, INC.
ShowCase Image Center
In Commercial Distribution

  • 00865885000237 ()
IC020

  • Radiology DICOM image processing application software
ShowCase Viewer for iPad is a DICOM medical image viewer for the Apple iPad. ShowCase Viewer for iPad is not intended for diagnostic use.
TRILLIUM TECHNOLOGY, INC.
ShowCase Viewer for iPad
In Commercial Distribution

  • 00865885000220 ()


  • Radiology DICOM image processing application software
MRS calculator
Aclarion, Inc.
Nocicalc
In Commercial Distribution

  • 00860010437209 ()
200-00301

  • Radiology DICOM image processing application software
Software that generates standardized metadata descriptions of medical images. The software also de-identifies PHI in metadata and image pixel data of medical images. The output of this functionality is used for various healthcare workflows such as hanging protocols, billing, and research. Using proprietary natural language processing (NLP) and computer vision (CV) algorithms, it reviews information from DICOM images and metadata to identify key attributes of radiological examinations for standardization, and for detecting and redacting PHI. It contains basic functionality such as user access and security, dashboards for analytics, and allows for integration with other devices such as third-party PACS software. Ensight does not aid in any diagnosis or provide any diagnostic information.
Enlitic, Inc.
2.0
In Commercial Distribution

  • 00860002304557 ()


  • Radiology DICOM image processing application software
Software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing and computer vision algorithms to analyze DICOM images and metadata to identify key attributes of radiological examinations and series.
Enlitic, Inc.
1.0.0
Not in Commercial Distribution

  • 00860002304540 ()


  • Radiology DICOM image processing application software
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