4 results
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10ms
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Sources: EU EUDAMED, US FDA
Sedecal SA Mobile Diagnost w DR x-ray system
FDA Enforcement
Class II
·Terminated·Sedecal USA, Inc.·June 15, 2016
RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·August 26, 2015
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·February 11, 2015
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·March 16, 2016