US FDA issues guidance on X-ray imagers:
This article was originally published in Clinica
The FDA has issued guidance on the submission of 510(k)s for solid state X-ray imagers that convert input x-rays directly to electrical signals. These devices are intended to replace conventional x-ray film/screen systems and image intensifier based fluoroscopes. SSXI's indicated for mammography do not fall within the scope of the guidance. Comments must be received within 30 days.
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