510(k) Report

Devices descending from K123585

14 later devices reach Syngo, CT Cardiac Function through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+1K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+2K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+2K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+2K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+3K241440HealthCCSngNano-X AI, Ltd.20240—
+3K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+3K230112CAC SoftwareImbio, Inc.20230—
+3K230223iCAC DeviceBunkerhill, Inc.20236—
+4K260166Bunkerhill Contrast CACBunkerHill Health20260—
+4K250662Bunkerhill MACBunkerHill Health20250—
+4K243229Bunkerhill AVCBunkerHill Health20253—
+4K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+5K260167Bunkerhill Contrast AVCBunkerHill Health20260—