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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.
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
No Description
Lunit Inc.
1.1
In Commercial Distribution
- 08800076000162 ()
- X-ray image interpretive software
No Description
Lunit Inc.
1.0
In Commercial Distribution
- 08800076000148 ()
- X-ray image interpretive software
No Description
Lunit Inc.
1.1
In Commercial Distribution
- 08800076000056 ()
- X-ray image interpretive software
No Description
GENORAY CO., LTD.
Zenis
In Commercial Distribution
- 08809244060137 ()
- X-ray image interpretive software
Critical Care Suite 2.1, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution
- 00195278789365 ()
- X-ray image interpretive software
The SpassageQ is a SaMD that automatically calculates the patient’s qSOFA score based on the six vital signs received from the HL7 gateway system and the GCS directly entered by the healthcare provider and notifies the user of signs of sepsis through visual alarms.
Spass Co.,Ltd.
1.0.0
In Commercial Distribution
- 08809957910002 ()
- Physiologic monitor-installed software
No Description
DRAEGER MEDICAL SYSTEMS, INC.
5736744
In Commercial Distribution
- 04049098053808 ()
- Patient monitoring system module, electroencephalographic