510(k) Report

Devices descending from K180326

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

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