FDA-Device2021-01-13Class II
TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
Accuray Incorporated
Hazard
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
Sold states
Worlwide distribution - US Nationwide distribution including in the states of CA, FL, IL, ND, NJ, OK, UT and the countries of Australia, China, Italy, Switzerland, United Arab Emirates.
Affected count
7 units
Manufactured in
1240 Deming Way, Madison, WI, United States
Products
TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0784-2021Don't want to check this manually?
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