| Health / Medical Topics |
Device Known Inherent Risk of Procedure Evaluation Conclusion
Device problems known and documented in the labeling (including both short or long term known complications or adverse reactions). (Food and Drug Administration)
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Testing that ionizing radiation is delivered at the appropriate energy and dose to the appropriate region of interest for the exam or…
A problem with the mechanical, electrical, or communication interface between two or more separate devices or components.
Testing devices for problems with the mechanical, electrical, or communication interface between two or more separate devices or components.
A test used with in vitro diagnostic analytic systems to detect substances that may be interfering with test results and causing…
The device software was found to contain errors in the user interface (including usability problems) or the interfaces with other systems. …
Testing the ability of a device's or component's material to resist the flow of electric current.
