> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Pediatric X-ray Guidance for 510(k) Submissions
- URL: https://www.fdaweb.com/pediatric-x-ray-guidance-for-510-k-submissions/
- Published: 2017-11-27T12:00:00.000Z
- Updated: 2026-09-14T23:03:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140206

FDA has released a [guidance](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM302938.pdf?utm%5Fcampaign=FDA%20Issues%20Final%20Guidance%20on%20Pediatric%20X-ray%20Imaging%20Device%20Notifications&utm%5Fmedium=email&utm%5Fsource=Eloqua&elqTrackId=0EF347C6581D75BDAAF0BACD565CE2B6&elq=447500c46d9b47e9905120e3cf5dbfe1&elqaid=1508&elqat=1&elqCampaignId=949) on “Pediatric Information for X-ray Imaging Device Premarket Notifications” that outlines the agency’s current thinking on information to include in 510(k)s for such devices that are indicated for pediatric populations or general use x-ray imaging devices when considerable pediatric use is anticipated.

The document urges manufacturers to consider child safety when designing X-ray devices, and it recommends that device makers design them with protocols and instructions that address pediatric use. It also provides recommendations for labeling and instructions for use for such devices.

Additionally, FDA says new X-ray devices should include clear and easily accessible information for imaging professionals on dose mitigation and management techniques, and instructions for imaging patients of all sizes. 

A [Webinar is planned on 1/9](http://www.fda.gov/cdrhwebinar?utm%5Fcampaign=FDA%20Issues%20Final%20Guidance%20on%20Pediatric%20X-ray%20Imaging%20Device%20Notifications&utm%5Fmedium=email&utm%5Fsource=Eloqua&elqTrackId=E3AB4F4136BAC38D89412B593D47FADE&elq=447500c46d9b47e9905120e3cf5dbfe1&elqaid=1508&elqat=1&elqCampaignId=949)[/18](http://www.fda.gov/cdrhwebinar?utm%5Fcampaign=FDA%20Issues%20Final%20Guidance%20on%20Pediatric%20X-ray%20Imaging%20Device%20Notifications&utm%5Fmedium=email&utm%5Fsource=Eloqua&elqTrackId=E3AB4F4136BAC38D89412B593D47FADE&elq=447500c46d9b47e9905120e3cf5dbfe1&elqaid=1508&elqat=1&elqCampaignId=949) for those wanting to learn more about the guidance recommendations.