FDA-Device2022-12-21Class II
Oncentra Brachy radiation therapy planning system software.
Elekta, Inc.
Hazard
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Sold states
Distribution US nationwide, including Puerto Rico. There was no military/government distribution.
Affected count
336 systems
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
Oncentra Brachy radiation therapy planning system software.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0719-2023Don't want to check this manually?
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