FDA-Device2016-05-04Class II
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
Elekta, Inc.
Hazard
The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.
Sold states
Worldwide Distribution - US Nationwide in the states of AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MI, MN, MS, MO, MT, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WV, WI, and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom
Affected count
217
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2016Don't want to check this manually?
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