> ## 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.

# Guidance on X-Ray Imaging Devices
- URL: https://www.fdaweb.com/guidance-on-x-ray-imaging-devices/
- Published: 2016-08-03T12:00:00.000Z
- Updated: 2026-09-14T21:20:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136386

*Federal Register* Notice: FDA is making available a draft guidance entitled *Medical X-Ray Imaging Devices Conformance With IEC Standards*. It describes FDA’s policy on regulating medical x-ray imaging equipment that is subject to requirements in the FD&C Act and the agency’s regulations that apply to medical devices and electronic products. The guidance also provides recommendations to industry on how to comply with the applicable requirements. To download this draft guidance, click [here. ](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514283?ref=fdaweb.com)To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-08-03/pdf/2016-18300.pdf?ref=fdaweb.com).