FDA 510(K) : The U.S. government’s FDA(Food and Drug Administration) approval is crucial in marketing and distribution of all manufactured products in the U.S. market. MySono201 has achieved the FDA approval in October 2000 and its certification number is K003121.

 CE mark : CE mark ensures that a manufactured product is O.K. by MDD(Medical Device Directive) set by the EU. Like FDA in the U.S. market, CE mark is necessary in all EU countries. MySono201 has achieved CE mark in October 2000.

 CSA/US : CSA/US is the safety certification approved by the U.S. and Canada. For the U.S. it’s UL2601-1 and for Canada it’s CSA22.2 No. 601.1. MySono201 has met both of the standards.

 CB certification : CB certification guarantees that MySono201 conforms to IEC60601-1(Electromechanical safety for Medical Equipments) which is the international medical equipment safety standard.

 ISO9001 : MySono201 achieved ISO9001, the international standard of system quality which is the internationally authorized assurance in design & development, manufacture, installation, service and other manufacturing factors.

 EN46001 : EN46001, a supplement to ISO9001 is the EU quality standard applied to medical equipment. MySono201 was also approved by this standard.

 MHW Shonin : MySono201 achieved MHW Shonin in August 7. 2001. Authorization number is 21300BZG00042000.