510(k) Report

Devices descending from K081112

3 later devices reach Flexiplan Brachytherapy Treatment Planning System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091145Flexiplan 3D and 3D+Isodose Control B.V.20092—
+2K123263Hdrplus, Add in Prostate Module for HdrplusEckert & Ziegler Bebig GmbH20131—
+3K141900Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate ModuleEckert & Ziegler Bebig GmbH201501