FDA-Device2015-06-10Class II
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Elekta, Inc.
Hazard
Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
Sold states
AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NC, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, Argentina, Australia, Bangladesh, Belarus, Botswana, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kosovo, Libya, Malaysia, Mexico, Morocco, Namibia, Nepal, New Zealand, Oman, Pakistan, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Suriname, Taiwan, Thailand, Tobago, Ukraine, Venezuela, Vietnam, Zambia
Affected count
351
Manufactured in
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, United States
Products
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1712-2015Don't want to check this manually?
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