510(k) Report

Devices descending from K080196

10 later devices reach Z3D Contrast Acuity through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081556Cadstream, Version 5.0Confirma, Inc.20099—
+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—