510(k) Report

Devices descending from K081512

27 later devices reach Stealthviz Advanced Planning Application with Stealthdti Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222359Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (O8t)20232—
+1K203518QuicktomeOmniscient Neurotechnology Pty Ltd (O8t)20214—
+1K162830SIS SoftwareSurgical Information Sciences, Inc.20179—
+1K092954Cadstream Version 5Confirma, Inc.200983
+2K251009Cirrus Resting State fMRI SoftwareSora Neuroscience, Inc.20250—
+2K243209nordicMEDiVANordicneurolab AS20240—
+2K241094BullsaiTuring Medical Technologies, Inc.20240—
+2K231130TumorSight VizSimBioSys, Inc.20232—
+2K230913ANDIImeka Solutions, Inc.20232—
+2K230150OptimMRIRebrain, Sas20231—
+2K183019SIS Software version 3.3.0Surgical Information Sciences, Inc.20196—
+2K170195QuantXQuantitative Insights, Inc.20174—
+3K252298ANDI 2.0Imeka Solutions, Inc.20251—
+3K243189TumorSight VizSimBioSys, Inc.20241—
+3K242054OptimMRI (v2)Rebrain, Sas20240—
+3K210670BU-CADTaihao Medical, Inc.20213—
+3K192304SIS Software Version 3.6.0Surgical Information Sciences, Inc.20195—
+4K260086CadAI-B DxBeamWorks, Inc.20260—
+4K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+4K261405ANDI 2.2Imeka Solutions, Inc.20260—
+4K251766TumorSight VizSimBioSys, Inc.20250—
+4K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+4K210071SIS System (Version 5.1.0)Surgical Information Sciences, Inc.20214—
+5K223032SIS System (Version 5.6.0)Surgical Information Sciences, Inc.20223—
+6K230977SIS SystemSurgical Information Sciences, Inc.20232—
+7K241083SIS SystemSurgical Information Sciences, Inc.20241—
+8K261795Quicktome Software SuiteOmniscient Neurotechnology Pty, Ltd.20260—