How AI should be used in radiology: assessing ambiguity and completeness of intended use statements of commercial AI products

How AI should be used in radiology: assessing ambiguity and completeness of intended use statements of commercial AI products

Abstract Background Intended use statements (IUSs) are mandatory to obtain regulatory clearance for artificial intelligence (AI)-based medical devices in the European Union. In order to guide the safe use of AI-based medical devices, IUSs need to contain comprehensive and understandable information....

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Bibliographic Details
Main Authors: Kicky G. van Leeuwen, Dennis M. Hedderich, Hugh Harvey, Steven Schalekamp
Format: Article
Language:English
Published: SpringerOpen 2024-02-01
Series:Insights into Imaging
Subjects:
Radiology
Artificial intelligence
Medical device legislation
Device approval process
Medical device safety
Online Access:https://doi.org/10.1186/s13244-024-01616-9

Internet

https://doi.org/10.1186/s13244-024-01616-9

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