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Home » FDA Issues Six X-Ray, Ultrasound and Laser Final Guidances
FDA Issues Six X-Ray, Ultrasound and Laser Final Guidances
The FDA explains the types of modifications to a diagnostic ultrasound device for which the agency does not intend to enforce the requirement for a new 510(k) filing, in a final guidance released yesterday — one of six newly released guidances from the agency related to imaging solutions and lasers.