510(k) Report

Devices descending from K072506

15 later devices reach Exactrac 5.5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133914Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH20142—
+1K120789Exactrac X-Ray X-RayBrainlab AG201286
+1K080742Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH20085—
+2K201276ExacTrac DynamicBrainlab AG202061
+2K192405Image Guidance System for RadiotherapyJiangsu Rayer Medical Technology Co., Ltd.20200—
+2K181789VeriSuiteMedcom GmbH20180—
+2K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+2K132847I2CIon Beam Applications S.A.201303
+2K092653Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH20093—
+3K220338ExacTrac DynamicBrainlab AG202231
+3K211939ExacTrac DynamicBrainlab AG202101
+3K203173ExacTrac DynamicBrainlab AG202001
+4K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceBrainlab AG20241—
+4K231052ExacTrac Dynamic 1.1.2Brainlab AG20230—
+5K254010ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceBrainlab SE20260—