510(k) Report

Devices descending from K113811

12 later devices reach V2.6 Software for the Labsystem Pro EP Recording System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140497Ecvue Mapping SystemCardioinsight Technologies, Inc.20148—
+1K141185V2.7 Software for the Labsystem Pro EP Recording SystemBoston Scientific Corp20142—
+2K230008Ablamap® SystemAblacon, Inc.20231—
+2K150990ECVUE Mapping SystemCardioinsight Technologies, Inc.20157—
+3K251344OptiMap™ SystemBoston Scientific Corporation20250—
+3K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc.20166—
+4K253861Acorys Mapping SystemCorify Care S.L20260—
+4K183195VIVOCatheter Precision, Inc.20191—
+4K181918CardioInsight Cardiac Mapping SystemMedtronic, Inc.20182—
+5K211546Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc.20211—
+5K200313VIVOCatheter Precision, Inc.20200—
+6K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—