510(k) Report

Devices descending from K101331

13 later devices reach Labsystem Pro EP Recording System V3.1 Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113811V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division201212—
+2K140497Ecvue Mapping SystemCardioinsight Technologies, Inc.20148—
+2K141185V2.7 Software for the Labsystem Pro EP Recording SystemBoston Scientific Corp20142—
+3K230008Ablamap® SystemAblacon, Inc.20231—
+3K150990ECVUE Mapping SystemCardioinsight Technologies, Inc.20157—
+4K251344OptiMap™ SystemBoston Scientific Corporation20250—
+4K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc.20166—
+5K253861Acorys Mapping SystemCorify Care S.L20260—
+5K183195VIVOCatheter Precision, Inc.20191—
+5K181918CardioInsight Cardiac Mapping SystemMedtronic, Inc.20182—
+6K211546Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc.20211—
+6K200313VIVOCatheter Precision, Inc.20200—
+7K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—