510(k) Report

Devices descending from K181939

18 later devices reach icobrain through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211222qER-QuantQure.Ai Technologies202113—
+1K192130IcobrainIcometrix NV20193—
+2K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc.20260—
+2K232363Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc.20242—
+2K231929iQ-solutionsSydney Neuroimaging Analysis Centre Pty, Ltd.20230—
+2K232083BriefCase-QuantificationAidoc Medical, Ltd.20230—
+2K223659JazzAi Medical AG20230—
+2K223180AIRAscoreAiramed GmbH20230—
+2K213165RapidIschemaview, Inc.20227—
+3K260406Brainomix 360 HyperdensityBrainomix Limited20260—
+3K252526Rapid DeltaFuseIschemaview, Inc.20250—
+3K250354Viz Subdural+, Viz SUBDURAL PLUSViz. Ai, Inc.20250—
+3K233582RapidIschemaview, Inc.20243—
+3K233512Rapid (6.0)Ischemaview, Inc.20241—
+4K261368Rapid Platform (R6.7)Ischemaview, Inc.20260—
+4K243350Rapid Neuro3DIschemaview, Inc.20251—
+4K242123Brainomix 360 e-CTABrainomix Limited20250—
+5K251987Rapid Aortic MeasurementsIschemaview, Inc.20250—