510(k) Report

Devices descending from K190802

3 later devices reach Envision ultrasound pad and cover through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.20260—
+1K211270CIV-Clear coverCIVCO Medical Instruments Co., Inc.20211—
+2K241662Ultrasound Transducer CoverVitrolife Sweden AB20240—