510(k) Report

Devices descending from K063456

9 later devices reach SRT100 Superficial Radiation Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132092EsteyaNucletron B.V.20131—
+1K123985Sensus Healthcare Superficial Radiotherapy System SRT-100Sensus Healthcare20137—
+2K213942EsteyaNucletron B.V.20220—
+2K172080Photoelectric Therapy SystemXstrahl, Ltd.201712
+2K131582Sensus Helthcare Image-Duided Superficial Radiotherapy SystemSensus Healthcare20134—
+3K230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.20230—
+3K150037Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging…Sensus Healthcare201531
+4K250692GentleBeam (GB1000)Voxel Ray Solutions, LLC20250—
+4K173425SRT-100+Sensus Healthcare, Inc.20180—