Part 8: Imaging Systems Guidance | COVID-19


Imaging Systems Guidance

Navigating the Regulatory Pathway during a Global Pandemic

What are the motivations for the COVID-19 Imaging Systems guidance?

    • Leverage current mobile radiological products and facilitate imaging systems changes for portable use so patients can undergo such procedures without entering a large healthcare facility.
    • Enable updates to current image software that can provide radiological findings to healthcare professional for diagnosis of a specific condition or monitoring of disease state/severity.
    • Increase availability of imaging devices to ease the increased burden on healthcare systems.

What medical device types are covered by this guidance?

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