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# Radiology Display Device Submission Guidance
- URL: https://www.fdaweb.com/radiology-display-device-submission-guidance/
- Published: 2022-09-29T12:00:00.000Z
- Updated: 2026-09-14T18:01:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152849

FDA has published a guidance, *Display Devices for Diagnostic Radiology*, to assist industry in preparing 510(k) submissions for display devices intended for use in diagnostic radiology. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/display-devices-diagnostic-radiology?ref=fdaweb.com) says while it is intended to apply to current technologies, FDA may request new or alternative methods to fully evaluate the safety and effectiveness of future display technologies. “In such instances,” it says, “we recommend that you contact FDA to determine the appropriate regulatory pathway and testing for your device prior to submitting a 510(k).”

The guidance supersedes a 5/30/2008 final guidance on 510(k) submissions for display accessories for full-field digital mammography systems.