Ocentra Masterplan 3.1 (Ocentra Brachy)

• • Terminated Z-1712-2015 FDA Class II ·initiated 21 May 2015

  Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

• • Terminated Z-0118-2013 FDA Class II ·initiated 21 Aug 2012

  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.

510(k) Number

K081281 ↗

FDA Product Code

MUJ

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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