Product
Regulatory Information
As a manufacturer of medical devices, TOPEX is subject to the regulations and oversight of the U.S. Food and Drug Administration (FDA). The SRT 100 is classified as a Class II device and is subject to performance standards outlined in the Code of Federal Regulations.
FDA 510K Clearance
TOPEX received 510K market clearance of the SRT 100 for use in treating skin cancer". This clearance was achieved on January 9th, 2007.International Regulation
International sales of medical devices are subject to foreign government regulations, which can vary substantially from country to country, The primary regulatory environment in Europe is that of the European Union which encompasses most of the major countries in Europe. The European Union has adopted numerous directives and standards regulating the design, manufacture and labeling for medical devices. Devices that comply with the requirements are entitled to bear CE (European Compliance) conformity marking, indicating the device conforms with essential requirements and can be commercially distributed throughout the European Union. TOPEX received approval on February 19, 2007 and was issued CE Certificates.