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Updated Status of FUJIFILM Medical Systems, U.S.A., Inc. Model ED

Audience: Users and reprocessors of the FUJIFILM Medical Systems, U.S.A., Inc. (Fujifilm) ED-530XT duodenoscope including:GastroenterologistsInfection control practitionersMedical Specialties: Gastroenterology, Infection ControlDevice: Fujifilm duodenoscope model ED-530XT is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.Purpose: The FDA is issuing this communication to provide updated status information about FDA clearance of Fujifilm's ED-530XT and...

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