FDA-Device2013-06-05Class II
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
RAYSEARCH LABORATORIES AB
Hazard
Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
Sold states
Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.
Affected count
Domestic: 70 units; Foreign: 27 units
Manufactured in
Sveavaegen 9, N/A, Stockholm, N/A, Sweden
Products
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is 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-1419-2013Don't want to check this manually?
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