510(k) Report

Devices descending from K011582

8 later devices reach Qcu Analytical Software Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092842EchoplaqueIndec Systems, Inc.20102—
+1K062985Ivus EnhancerIndec Systems, Inc.20060—
+1K022940IN-Vision View with Measurements Module, Model 1.0Intelligent Images Srl20023—
+1K021495QIVAPie Medical Imaging BV20023—
+2K123970Caas IntravascularPie Medical Imaging BV20131—
+2K041581Compacs, Version 1.0Intelligent Images Srl20041—
+3K210931Libby IAAA v1.0Dyad Medical, Inc.20210—
+3K120514CardiopacsLumedx20120—