FDA-Device2015-03-11Class II
Focal Sim radiation therapy treatment planning system
Elekta, Inc.
Hazard
Incorrect CT to ED when using the Monaco Image Statistics Tool.
Sold states
Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulgaria, Bahrain, Brazil, Belarus, Canada, Chile, China, Colombia, Cuba, Cyprus, Czech Republic, Germany, Algeria, Egypt, Spain, France, Great Britain, Greece, Croatia, Indonesia, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Sri Lanka, Lithuania, Libya, Morocco, Macedonia, Mexico, Malaysia, New Zealand, Philippines, Portugal, Romania, Serbia, Russia, Singapore, Slovenia, Suriname, Thailand, Turkey, Ukraine, Venezuela, South Africa, Kosovo.
Affected count
907
Manufactured in
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, United States
Products
Focal Sim radiation therapy treatment planning system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1244-2015Don't want to check this manually?
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