510(k) Report

Devices descending from K041286

17 later devices reach Dynacad V1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+1K173744ProFuse CADEigen20181—
+1K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+1K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+1K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+1K081556Cadstream, Version 5.0Confirma, Inc.20099—
+2K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+2K173312ProBx SoftwareHarmonus, Inc.20180—
+2K170195QuantXQuantitative Insights, Inc.20174—
+2K092954Cadstream Version 5Confirma, Inc.200983
+3K231130TumorSight VizSimBioSys, Inc.20232—
+3K210670BU-CADTaihao Medical, Inc.20213—
+4K260086CadAI-B DxBeamWorks, Inc.20260—
+4K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+4K243189TumorSight VizSimBioSys, Inc.20241—
+4K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+5K251766TumorSight VizSimBioSys, Inc.20250—