Device Labeled for Single Use

A device that is intended for one use, or on a single patient during a single procedure (Title 21 Chapter 9 Federal Food, Drug and Cosmetic Act). (NCI Thesaurus)

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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).

Device Ionizing Radiation Testing Evaluation Method

Testing that ionizing radiation is delivered at the appropriate energy and dose to the appropriate region of interest for the exam or…

Device Interoperability Problem Evaluation Result

A problem with the mechanical, electrical, or communication interface between two or more separate devices or components.

Device Interoperability Evaluation Method

Testing devices for problems with the mechanical, electrical, or communication interface between two or more separate devices or components.

Device Interference Substance Testing Evaluation Method

A test used with in vitro diagnostic analytic systems to detect substances that may be interfering with test results and causing…

Device Interface Design Error Evaluation Result

The device software was found to contain errors in the user interface (including usability problems) or the interfaces with other systems. …