Device Labeler Support Contact

Definition 1

Support contact information for a device labeler. (NCI Thesaurus)

Definition 2

A public-facing support contact for the Labeler company responsible to support the reported device. (Food and Drug Administration)

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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).

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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…

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

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