FDA-Device2014-09-10Class II
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
Elekta, Inc.
Hazard
When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.
Sold states
Worldwide Distribution - US (nationwide)in the states of AK, CA, FL, MI, MN, MO, NJ, NY, NC, OH, PA, TN, VA,WA and Puerto Rico, Algeria, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech republic, Ecuador, Egypt, Estonia, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Pakistan Portugal, Romania, Russia, Saudi Arabia, Singapore, Solvenia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom
Affected count
554 units
Manufactured in
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, United States
Products
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2574-2014Don't want to check this manually?
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