510(k) Report

Devices descending from K181084

3 later devices reach PENTAX Video Colonoscopes (EC Family) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192588G-EYE SystemSmart Medical Systems, Ltd.20202—
+2K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+3K220158G-EYE SystemSmart Medical Systems, Ltd.20220—