ThinkSono Guidance is currently only CE IIb marked for clinical use in the EU and UK. It is not FDA approved. Please contact ThinkSono for more information. The CE Class IIb intended purpose of ThinkSono Guidance is found in the instructions for use (IFU). ThinkSono Guidance EU manufacturer is ThinkSono GmbH (EUDAMED SRN number: DE-MF-000034914). To buy and use ThinkSono Guidance please send an email to hello@thinksono.com