510(k) Report

Devices descending from K183268

11 later devices reach AI-Rad Companion (Cardiovascular) through their predicates, nearest generation first.

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