FLUOROspeed X1 is a conventional RF table system offering high image quality and a multitude of features that improve workflow and operator efficiencies.
EsoCheck is a non-invasive cell collection device designed to sample cells from a targeted region of the esophagus in a five-minute office-based procedure.
The agency believes that additional changes are needed to fully modernize the 510(k) program.
Scott Gottlieb, M.D. & Jeff Shuren, M.D.;, Commissioner & Director of the Center for Devices and Radiological Health; U.S. Food and Drug Administration04.30.19