FDA-Device2016-06-01Class II
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Elekta, Inc.
Hazard
If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.
Sold states
IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
Affected count
20
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1705-2016Don't want to check this manually?
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