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Display Devices for Diagnostic Radiology Guidance for Industry and Food and Drug Administration Staff September 2022

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides FDA’s recommendations regarding premarket notification (510(k)) submissions for display devices intended for use in diagnostic radiology. This guidance applies to display devices intended for diagnostic radiology as identified by their classification regulation (21 CFR 892.2050) and product codes. This includes display devices for diagnostic radiology that may be referred to as soft-copy display or medical grade monitors. The recommendations are intended to promote consistency and facilitate efficient review of display devices.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-0270.

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