FDA-Device2014-02-12Class II
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Elekta, Inc.
Hazard
When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
Sold states
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, QA, WA, WV, WI, and WY, and the countries of Albania, Algeria, Argentina, Austria, Australia, Bosnia, Bulgaria, Belgium, Bahrain, Brazil, Belarus, Botswana, Bangladesh, Canada, China, Columbia, Costa Rica, Croatia, Cuba, Cyprus, Chile, Czech Republic, Ecuador, Egypt, Estonia, France, Finland, Gabon, Germany, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Italy, Ireland, Israel, Iraq, Jordan, Japan, Kosovo, Kuwait, Lithuania, Libya, Latvia, Morocco, Malaysia, Malta, Mexico, Myanmar, Netherland, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sudan, Syria, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, Venezuela, and Vietnam.
Affected count
1424
Manufactured in
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, United States
Products
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2014Don't want to check this manually?
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