510(k) Report

Devices descending from K201034

2 later devices reach Syngo.CT CaScoring through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+1K221219syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20220—