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# CDRH Guide on 510(k) for Solid State X-ray Devices
- URL: https://www.fdaweb.com/cdrh-guide-on-510-k-for-solid-state-x-ray-devices/
- Published: 2016-09-01T12:00:00.000Z
- Updated: 2026-09-14T21:29:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136681

CDRH has released a [guidance ](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073781.pdf?ref=fdaweb.com)on “Submission of 510(k)s for Solid State X-ray Imaging Devices” that outlines the type of data to establish the substantial equivalence of such devices to a previously cleared conventional radiographic film/screen system, fluoroscopic image intensified imaging system, or similar device. The devices covered by the guidance are transducers (typically flat rectangular panels) that intercept x-ray photons, and through one of several processes convert the photon energy into an electrical signal that is subsequently used to create a visible image.