FDA-Device2014-04-09Class II
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
RAYSEARCH LABORATORIES AB
Hazard
Potential for dose errors due to software program errors.
Sold states
Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain.
Affected count
151 units Total (88 units domestically & 63 units internationally)
Manufactured in
Sveavaegen 9, N/A, Stockholm, N/A, Sweden
Products
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1307-2014Don't want to check this manually?
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