FDAnews
www.fdanews.com/articles/138933-edap-gains-u-s-fda-510-k-lithotripter-clearance

EDAP Gains U.S. FDA 510(k) Lithotripter Clearance

August 3, 2011
EDAP TMS announced it received marketing clearance from the U.S. Food and Drug Administration (FDA) for its Sonolith i-move device, a technologically advanced compact mobile lithotripter.
MarketWatch