510(k) Report

Devices descending from K170195

4 later devices reach QuantX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210670BU-CADTaihao Medical, Inc.20213—
+2K260086CadAI-B DxBeamWorks, Inc.20260—
+2K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+2K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—