510(k) Report

Devices descending from K213438

3 later devices reach 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243057TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc.20241—
+1K241318Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc.20240—
+2K260308TrueFit BolusAdaptiiv Medical Technologies, Inc.20260—