FDA-Device2024-05-08Class II
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
Hazard
Potential for reported SSD to be too high.
Sold states
Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.
Affected count
66 units
Manufactured in
Eugeniavagen 18c, Stockholm, Sweden
Products
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1749-2024Don't want to check this manually?
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