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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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BRAINOMIX LIMITED
2.2
In Commercial Distribution

  • B720BX360ELUNG220 ()


  • X-ray image interpretive software
Rho radiology software for opportunistic evaluation of low bone mineral density.
16 Bit Inc.
Rho
In Commercial Distribution

  • 06287194090220 ()


  • X-ray image interpretive software
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Screenpoint Medical B.V.
1.7.y
In Commercial Distribution

  • 08719326450131 ()


  • X-ray image interpretive software
The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms from compatible FFDM systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on suspicious soft tissue lesions and suspicious calcifications, region based scores, displayed upon the physicians query, indicating the likelihood that cancer is present in specific regions, and an overall score indicating the likelihood that cancer is present on the mammogram. Patient management decisions should not be made solely on the basis of analysis by Transpara.
Screenpoint Medical B.V.
1.5.0 2D
In Commercial Distribution

  • 08719326450124 ()


  • X-ray image interpretive software
Transpara™ software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara™.
Screenpoint Medical B.V.
1.x.y
In Commercial Distribution

  • 08719326450117 ()


  • X-ray image interpretive software
The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on suspicious soft tissue lesions and suspicious calcifications; region‐based scores, displayed upon the physician’s query, indicating the likelihood that cancer is present in specific regions; and an overall score indicating the likelihood that cancer is present on the mammogram. Patient management decisions should not be made solely on the basis of analysis by Transpara.
Screenpoint Medical B.V.
1.3.y
In Commercial Distribution

  • 08719326450100 ()


  • X-ray image interpretive software
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Screenpoint Medical B.V.
2.Y.Z
In Commercial Distribution

  • 08720387058051 ()


  • X-ray image interpretive software
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Screenpoint Medical B.V.
2.Y.Z
In Commercial Distribution

  • 08720387058044 ()


  • X-ray image interpretive software
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Screenpoint Medical B.V.
1.7.2
In Commercial Distribution

  • 08720387058013 ()


  • X-ray image interpretive software
StrokeViewer is an image processing software application that analyzes CT scans of the brain to provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients.
NICo-Lab B.V.
1
In Commercial Distribution

  • 08720299502352 ()


  • X-ray image interpretive software
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