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Is the 510(k) Pathway Robust Enough for the Era of AI?

Published in:Applied Radiology pp. 26 - 28
Main Author: Harvey, Hugh
Format: pictorial Journal Article
Published: Anderson Publishing Ltd. Mar/Apr2023
Online Access:View this record in EBSCOhost
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      dt: Mar/Apr2023
      pid: 6733
      pub: Anderson Publishing Ltd.
      place: Scotch Plains, New Jersey
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        atl: Is the 510(k) Pathway Robust Enough for the Era of AI?
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        au: Harvey, Hugh
        affil: Managing director of Hardian Health, based in Haywards Heath, England
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          Radiology Service
          Artificial Intelligence Standards
          United States Food and Drug Administration
          Patient Safety
          Device Approval
      pubtype: Academic Journal
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        pictorial
        Journal Article
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