510(k) Report

Devices descending from K101138

1 later device reach Soundstar 3D Ultrasound Catheter Model M-5723-12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC20170—