510(k) Report

Devices descending from K213725

4 later devices reach CardIQ Suite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252217CT VScore+Canon Medical Informatics, Inc.20250—
+1K233731CardIQ SuiteGE Medical Systems SCS20242—
+2K243672CardIQ SuiteGE Medical Systems SCS20251—
+3K253770CardIQ SuiteGE Medical Systems SCS20260—