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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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VolparaDoseRT - 09421904268104

VolparaDoseRT 3.3 (including VolparaPressure and VolparaPosition)
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.3
In Commercial Distribution

  • 09421904268104 ()


  • Radiology DICOM image processing application software

VolparaDoseSR - 09421904268302

VolparaDoseSR 4.0
VOLPARA HEALTH TECHNOLOGIES LIMITED
4.0
In Commercial Distribution

  • 09421904268302 ()


  • Radiology DICOM image processing application software

VolparaDoseSR - 09421904268272

VolparaDoseSR 3.4.2
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.2
In Commercial Distribution

  • 09421904268272 ()


  • Radiology DICOM image processing application software

VolparaDoseRT - 09421904268265

VolparaDoseRT 3.4.2
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.4.2
In Commercial Distribution

  • 09421904268265 ()


  • Radiology DICOM image processing application software

VolparaServer - 09421904268074

VolparaServer 1.3
VOLPARA HEALTH TECHNOLOGIES LIMITED
1.3
In Commercial Distribution

  • 09421904268074 ()


  • Radiology DICOM image processing application software

VolparaDoseSR - 09421904268043

VolparaDoseSR 3.2
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.2
Not in Commercial Distribution

  • 09421904268043 ()


  • Radiology DICOM image processing application software

VolparaDoseRT - 09421904268036

VolparaDoseRT 3.2
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.2
Not in Commercial Distribution

  • 09421904268036 ()


  • Radiology DICOM image processing application software

PULSAR - 04048551242513

KARL STORZ PULSAR II Stroboscope
Karl Storz GmbH & Co. KG
40160120
In Commercial Distribution

  • 04048551242513 ()


  • Laryngostroboscope system

Luxsonic Virtual Imaging - Clinical - G554LVIC0

No Description
Luxsonic Technologies, Inc
1.x
In Commercial Distribution

  • G554LVIC0 ()


  • Radiology DICOM image processing application software

Ensight - 00860002304557

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
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