510(k) Report

Devices descending from K162793

3 later devices reach RHYTHMIA HDx Mapping System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241227RHYTHMIA HDx™ Mapping SystemBoston Scientific Corporation20240—
+1K173837RHYTHMIA HDx Mapping System (with software Version 2.0)Boston Scientific Corporation20182—
+2K192438Rhythmia HDxTM Mapping SystemBoston Scientific Corporation20191—