510(k) Report

Devices descending from K251234

4 later devices reach EnSite™ X EP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+1K260212EnSite™ X EP SystemAbbott Medical20262—
+2K261729EnSite™ X EP SystemAbbott Medical20260—
+2K262006EnSite™ X EP SystemAbbott Medical20260—