510(k) Report

Devices descending from K161148

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180326icobrainIcometrix201819—
+1K171328cNeuro cMRICombinostics OY20181—
+2K231398VUNO Med-DeepBrainVuno, Inc.20230—
+2K181939icobrainIcometrix NV201818—
+3K211222qER-QuantQure.Ai Technologies202113—
+3K192130IcobrainIcometrix NV20193—
+4K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc.20260—
+4K232363Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc.20242—
+4K231929iQ-solutionsSydney Neuroimaging Analysis Centre Pty, Ltd.20230—
+4K232083BriefCase-QuantificationAidoc Medical, Ltd.20230—
+4K223659JazzAi Medical AG20230—
+4K223180AIRAscoreAiramed GmbH20230—
+4K213165RapidIschemaview, Inc.20227—
+5K260406Brainomix 360 HyperdensityBrainomix Limited20260—
+5K252526Rapid DeltaFuseIschemaview, Inc.20250—
+5K250354Viz Subdural+, Viz SUBDURAL PLUSViz. Ai, Inc.20250—
+5K233582RapidIschemaview, Inc.20243—
+5K233512Rapid (6.0)Ischemaview, Inc.20241—
+6K261368Rapid Platform (R6.7)Ischemaview, Inc.20260—
+6K243350Rapid Neuro3DIschemaview, Inc.20251—
+6K242123Brainomix 360 e-CTABrainomix Limited20250—
+7K251987Rapid Aortic MeasurementsIschemaview, Inc.20250—