510(k) Report

Devices descending from K211222

13 later devices reach qER-Quant through their predicates, nearest generation first.

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