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# CDRH Guidance on Radiology Display Devices
- URL: https://www.fdaweb.com/cdrh-guidance-on-radiology-display-devices/
- Published: 2016-02-08T12:00:00.000Z
- Updated: 2026-09-15T02:34:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134693

> CDRH has posted a [draft guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM484914.pdf?ref=fdaweb.com) on “Display Devices for Diagnostic Radiology” to assist industry in preparing premarket notification submissions for display devices intended for use in diagnostic radiology. The document is intended to apply to current technologies, but the Center says it may request new or alternative test methods to fully evaluate the safety and effectiveness of future displays. For new technologies, it recommends that sponsors contact the agency to determine the appropriate regulatory pathway and testing for the device prior to submitting a premarket notification.  
>  
> CDRH says such devices are classified as Class 2 devices that are intended to be used in controlled viewing conditions to display and view digital images for primary image interpretation. Display devices for diagnostic radiology may also be referred to as soft-copy displays or medical grade monitors, it says.