FDA-Device2012-10-31Class II
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Elekta, Inc.
Hazard
During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.
Sold states
Nationwide Distribution-including the states of AL, CA, DC, KS, LA, MO, NB, NY, NC, ND, OH, OR, PA, RI, SC, TX, and WA.
Affected count
52 units
Manufactured in
4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross, GA, United States
Products
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2013Don't want to check this manually?
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