A guidance has been posted titled, “Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - Guidance for Industry and Food and Drug Administration Staff."
This guidance applies to the category of medical imaging devices, Solid State X-ray Imagers (SSXI), that convert x-ray patterns into electrical signals. The signals can in turn, with or without processing, be converted into visible images for use in medical diagnosis. These devices are intended to be used in place of conventional x-ray film/screen systems, and image intensifier based fluoroscopic and image recording systems. SSXI’s indicated for mammography do not fall within the scope of this guidance.
To view the Guidance, please see: http://www.fda.gov/downloads/
MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm073781. pdf.