510(k) Report

Devices descending from K061855

57 later devices reach Neuroquant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213645ClearPoint Maestro Brain ModelClearPoint Neuro, Inc.20222—
+1K171328cNeuro cMRICombinostics OY20181—
+1K170981NeuroQuantCortechs Labs, Inc.201728—
+1K161322CT CoPilotZepmed, LLC20160—
+1K161148icobrainIcometrix201622—
+1K140828Neuroreader Medical Image Processing SoftwareBrainreader Aps201511
+2K260032MorphBeauBrain Healthcare, Inc.20260—
+2K250686GyriCalc (Version 1.0.0)Neurospectrum Insights Corp.20250—
+2K241098NeuroQuantCortechs Labs, Inc.20242—
+2K232231QP-Brain®Quibim S.L.20232—
+2K233243ClearPoint System (Software Version 2.2)ClearPoint Neuro, Inc.20231—
+2K231398VUNO Med-DeepBrainVuno, Inc.20230—
+2K230187Terran NM-101Terran Biosciences, Inc.20230—
+2K220034NEUROShieldIn-Med Prognostics L3c20231—
+2K213253Pixyl.NeuroPixyl SA20230—
+2K220437Neurophet AQUANeurophet., Inc.20233—
+2K221738NS-HGlioNeosoma, Inc.20223—
+2K202847AccuBrainBrainnow Medical Technology Limited20210—
+2K202414BrainInsightHyperfine Research, Inc.20212—
+2K193287CorInsights MRIAdm Diagnostics, Inc.20200—
+2K192051THINQCorticometrics, LLC20201—
+2K192531QyScore SoftwareQynapse20190—
+2K180326icobrainIcometrix201819—
+3K260316CMN Capillary Function with Oncology Virtual ExpertCercare Medical A/S20260—
+3K252496Neurophet AQUA AD PlusNeurophet., Inc.20261—
+3K252670AlzevitaTopia Medtech Limited20250—
+3K243863Opulus™ Lymphoma PrecisionRoche Molecular Systems, Inc.20250—
+3K250416GBrain MRIGalileo Cds, Inc.20251—
+3K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc.20250—
+3K242215Neurophet AQUA (V3.1)Neurophet., Inc.20242—
+3K241280Constellation (CON-001)Q Bio, Inc.20240—
+3K233822i2ContourMrimath, LLC20240—
+3K220815BrainInsightHyperfine, Inc.20221—
+3K181939icobrainIcometrix NV201818—
+4K261273Neurophet AQUANeurophet., Inc.20260—
+4K252563Neurophet SCALE PETNeurophet., Inc.20260—
+4K251483SwiftSight-BrainAirs Medical, Inc.20250—
+4K252362GBrain MRIGalileo Cds, Inc.20250—
+4K223268BrainInsightHyperfine, Inc.20220—
+4K211222qER-QuantQure.Ai Technologies202113—
+4K192130IcobrainIcometrix NV20193—
+5K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc.20260—
+5K232363Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc.20242—
+5K231929iQ-solutionsSydney Neuroimaging Analysis Centre Pty, Ltd.20230—
+5K232083BriefCase-QuantificationAidoc Medical, Ltd.20230—
+5K223659JazzAi Medical AG20230—
+5K223180AIRAscoreAiramed GmbH20230—
+5K213165RapidIschemaview, Inc.20227—
+6K260406Brainomix 360 HyperdensityBrainomix Limited20260—
+6K252526Rapid DeltaFuseIschemaview, Inc.20250—
+6K250354Viz Subdural+, Viz SUBDURAL PLUSViz. Ai, Inc.20250—
+6K233582RapidIschemaview, Inc.20243—
+6K233512Rapid (6.0)Ischemaview, Inc.20241—
+7K261368Rapid Platform (R6.7)Ischemaview, Inc.20260—
+7K243350Rapid Neuro3DIschemaview, Inc.20251—
+7K242123Brainomix 360 e-CTABrainomix Limited20250—
+8K251987Rapid Aortic MeasurementsIschemaview, Inc.20250—