510(k) Report

Devices descending from K123985

7 later devices reach Sensus Healthcare Superficial Radiotherapy System SRT-100 through their predicates, nearest generation first.

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