510(k) Report

Devices descending from K172983

14 later devices reach HealthCCS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+1K192763syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20193—
+2K241440HealthCCSngNano-X AI, Ltd.20240—
+2K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+2K230112CAC SoftwareImbio, Inc.20230—
+2K230223iCAC DeviceBunkerhill, Inc.20236—
+2K201034Syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20202—
+3K260166Bunkerhill Contrast CACBunkerHill Health20260—
+3K250662Bunkerhill MACBunkerHill Health20250—
+3K243229Bunkerhill AVCBunkerHill Health20253—
+3K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+3K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+3K221219syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20220—
+4K260167Bunkerhill Contrast AVCBunkerHill Health20260—