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Are TomoTherapy Incorporated’s products cleared by the U.S. Food & Drug Adminstration (FDA) and other regulatory agencies?

April 26, 2017adminstration drug fda food incorporated products regulatory tomotherapy

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Are TomoTherapy Incorporated’s products cleared by the U.S. Food & Drug Adminstration (FDA) and other regulatory agencies?

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TomoTherapy Incorporated has received clearance from authorities to market the TomoTherapy Hi·Art treatment system in the U.S., as well as Canada, the European Union, Japan, India, Taiwan, South Korea, Israel, Turkey, Australia, Singapore and Hong Kong . The system is not available for sale in markets where relevant regulatory clearances have not been obtained. We will continue to update this page as we obtain these clearances.