iViz has 510(k) clearance from the FDA

SonoSite iViz

Body 3

SonoSite iViz receives 510k and FDA approval mid November, after two months of  receiving the CE Mark for Europe in mid September.  “iViz is a revolutionary solutions for clinicians and represents a landmark in FUJIFILM SonoSite's innovation.  It achieves new levels of image performance and provides unprecedented connectivity in a highly mobile platform”.

Link: http://www.businesswire.com/news/home/20151117006403/en