510(k) Report

Devices descending from K043350

12 later devices reach Mistar, Model V3.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+2K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+3K081556Cadstream, Version 5.0Confirma, Inc.20099—
+4K170195QuantXQuantitative Insights, Inc.20174—
+4K092954Cadstream Version 5Confirma, Inc.200983
+5K231130TumorSight VizSimBioSys, Inc.20232—
+5K210670BU-CADTaihao Medical, Inc.20213—
+6K260086CadAI-B DxBeamWorks, Inc.20260—
+6K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+6K243189TumorSight VizSimBioSys, Inc.20241—
+6K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K251766TumorSight VizSimBioSys, Inc.20250—